An Observational Study to Evaluate the Incidence of Clinically Suspicious Lambert-Eaton Myasthenic Syndrome (LEMS) in Subjects Diagnosed With Small Cell Lung Cancer (SCLC)
Conditions: Small Cell Lung Cancer ( SCLC ), Lambert Eaton Myasthenic Syndrome (LEMS)
Sponsor: Addario Lung Cancer Medical Institute

 
 
 
Protocol: ALCMI-024  
 
 
    Version:12 June 2025  
CONFIDENTIAL – PROPRIETARY INFORMATION 
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Clinical Protocol ALCMI-024 
 
An Observational Study to Evaluate the Incidence of Clinically Suspicious 
Lambert-Eaton Myasthenic Syndrome (LEMS) in Subjects Diagnosed with Small 
Cell Lung Cancer (SCLC) 
 
Issue Date(s): 12 June 2025 
  
Issue Version V 1.0  
 
IND Status: Exempt 
 
 
Principal Investigator 
Jacob M. Sands, MD 
Thoracic Oncologist Dana-Farber Cancer 
Institute (DFCI) 
Assistant Prof of Medicine, Harvard Medical 
School  
450 Brookline Ave.  
Boston, MA 02215 
Phone: 617-632-6049 
Email: Jacob_sands@dfci.harvard.edu 
 Co-Principal Investigator 
Gilbert Youssef, MD 
  Neuro-Oncologist, Dana-Farber Cancer 
Institute (DFCI) 
Instructor in Neurology, Harvard Medical School  
450 Brookline Ave.  
Boston, MA 02215 
Phone: 817-632-6177 
Email: Gilbert_youssef@dfci.harvard.edu 
 
Study Manager 
Allison M. Harper, PharmD 
Director of Clinical Research 
Addario Lung Cancer Medical Inst (ALCMI) 
Phone: 704-996-6579 
Email: aharper@alcmi.org 
 
Sponsor 
ADDARIO LUNG CANCER MEDICAL INSTITUTE (ALCMI) 
1100 Industrial Rd, Suite 1 
San Carlos, CA  94070 
 
 
This protocol contains information that is confidential and proprietary to  
Addario Lung Cancer Medical Institute (ALCMI) 

 
 
 
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TABLE OF CONTENTS 
 
1 
INTRODUCTION ............................................................................................................................................................ 7 
1.1 
BACKGROUND ................................................................................................................................................................ 7 
1.2 
RATIONALE .................................................................................................................................................................... 7 
1.3 
OVERALL BENEFIT/RISK ASSESSMENT........................................................................................................................... 7 
2 
STUDY OBJECTIVES .................................................................................................................................................... 8 
2.1 
PRIMARY OBJECTIVE ...................................................................................................................................................... 8 
2.2 
SECONDARY OBJECTIVE(S) ............................................................................................................................................ 8 
3 
STUDY DESIGN AND EVALUATION ........................................................................................................................ 8 
3.1 
STUDY DESIGN ............................................................................................................................................................... 8 
3.1.1 
Duration of Study ................................................................................................................................................. 9 
3.1.2 
Screening / Enrollment ........................................................................................................................................ 9 
3.1.3 
Observation Period .............................................................................................................................................. 9 
3.1.4 
Study Administration Structure .......................................................................................................................... 10 
3.2 
STUDY POPULATION ..................................................................................................................................................... 10 
3.3 
CRITERIA FOR EVALUATION ......................................................................................................................................... 10 
4 
STATISTICICS .............................................................................................................................................................. 10 
4.1 
SAMPLE SIZE DETERMINATION .................................................................................................................................... 10 
4.2 
DATA SET DESCRIPTIONS ............................................................................................................................................. 11 
4.3 
DATA SET ANALYSES ................................................................................................................................................... 11 
4.3.1 
Interim Analysis ................................................................................................................................................. 11 
4.3.2 
Safety Analyses .................................................................................................................................................. 11 
5 
DATA MANAGEMENT ............................................................................................................................................... 11 
5.1 
DATABASE DESIGN AND CREATION ............................................................................................................................. 11 
5.2 
DATA CODING .............................................................................................................................................................. 12 
5.3 
DATA ENTRY AND VERIFICATION ................................................................................................................................ 12 
5.4 
DATA TRANSFER .......................................................................................................................................................... 12 
5.5 
DATABASE LOCK ......................................................................................................................................................... 12 
6 
SUBJECT SELECTION AND DISCONTINUATION ............................................................................................... 12 
6.1 
INCLUSION ................................................................................................................................................................... 12 
6.2 
EXCLUSION .................................................................................................................................................................. 13 
6.3 
SUBJECT DISCONTINUATION ........................................................................................................................................ 13 
6.3.1 
Subject Discontinuation Criteria ....................................................................................................................... 13 
6.3.2 
Procedures for Discontinuation ......................................................................................................................... 13 
6.3.3 
Replacement of Subjects .................................................................................................................................... 13 
7 
STUDY PROCEDURES AND OBSERVATIONS ...................................................................................................... 14 
7.1 
TIME AND EVENTS SCHEDULE (FLOW CHART) ............................................................................................................. 14 
7.2 
PROCEDURES BY VISIT ................................................................................................................................................. 14 
7.2.1 
Screening Period* (Day -15 to Day 0) .............................................................................................................. 14 
7.2.2 
Enrollment visit* (Day 0) ................................................................................................................................... 14 
7.2.3 
Quarterly Observational visits (Q 3 months) ..................................................................................................... 15 
7.2.4 
End of Study visit ............................................................................................................................................... 15 
7.3 
SUBJECT ASSESSMENTS................................................................................................................................................ 15 
7.3.1 
Demographics .................................................................................................................................................... 15 
7.3.2 
SCLC Cancer diagnosis and Treatment, relevant medical history .................................................................... 15 

 
 
 
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7.3.3 
Symptom Directed Neurological Evaluation...................................................................................................... 15 
7.3.4 
VGCC Antibody Blood draw .............................................................................................................................. 16 
7.3.5 
Investigator Course of Action Form .................................................................................................................. 16 
8 
INVESTIGATIONAL PRODUCT ............................................................................................................................... 16 
9 
ADVERSE EVENT REPORTING IN CLINICAL TRIALS ..................................................................................... 16 
10 
QUALITY ASSURANCE .............................................................................................................................................. 17 
10.1 
COMPLIANCE WITH PROTOCOL AND PROTOCOL REVISIONS .................................................................................... 17 
10.2 
MONITORING FOR PROTOCOL COMPLIANCE ............................................................................................................ 17 
11 
ETHICAL AND LEGAL CONSIDERATIONS .......................................................................................................... 18 
11.1 
INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC) .................................................... 18 
11.2 
INFORMED CONSENT ............................................................................................................................................... 18 
11.2.1 
Informed Consent Procedures ....................................................................................................................... 18 
11.2.2 
Subjects Unable to Give Informed Consent................................................................................................... 19 
11.2.2.1 
Minors ........................................................................................................................................................................ 19 
11.2.2.2 
Patients Experiencing Acute Events or Emergencies ................................................................................................. 19 
11.2.2.3 
Mentally Impaired or Incapacitated Subjects ............................................................................................................. 19 
11.2.2.4 
Other Circumstances .................................................................................................................................................. 19 
11.2.3 
Illiterate Subjects .......................................................................................................................................... 19 
11.2.4 
Update of Informed Consent ......................................................................................................................... 20 
11.3 
CONFIDENTIALITY ................................................................................................................................................... 20 
11.3.1 
Confidentiality of Data .................................................................................................................................. 20 
11.3.2 
Confidentiality of Patient Records ................................................................................................................ 20 
11.3.3 
Confidentiality of Investigator Information................................................................................................... 20 
11.4 
PUBLICATIONS AND OTHER RIGHTS ........................................................................................................................ 20 
11.4.1.1 
Responsibilities .......................................................................................................................................................... 21 
11.4.1.2 
Patents ........................................................................................................................................................................ 21 
11.4.1.3 
Right to Use ............................................................................................................................................................... 22 
12 
ADMINISTRATIVE ...................................................................................................................................................... 22 
12.1 
RECORDS AND REPORTS .......................................................................................................................................... 22 
12.2 
RECORDS RETENTION .............................................................................................................................................. 22 
12.3 
SPONSOR ................................................................................................................................................................. 23 
12.4 
INVESTIGATORS, INVESTIGATIONAL SITES AND IRBS ............................................................................................. 23 
12.5 
CENTRAL ORGANIZATIONS AND/OR VENDORS ........................................................................................................ 23 
13 
LIST OF ABBREVIATIONS ........................................................................................................................................ 24 
14 
REFERENCES ............................................................................................................................................................... 25 
15 
APPENDICES ................................................................................................................................................................ 26 
15.1 
APPENDIX 1:  QUEST LAB ORDER ............................................................................................................................ 26 
15.2 
APPENDIX 2: LEMS SYMPTOM DIRECTED NEUROLOGICAL EVALUATION .............................................................. 27 
15.3 
APPENDIX 3: INVESTIGATOR COURSE OF ACTION FORM ......................................................................................... 29 
 
Tables 
TABLE 4.1  STUDY ADMINISTRATIVE STRUCTURE. ................................................................... 10 
 

 
 
 
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PROTOCOL SIGNATURE PAGE  
 
Study Protocol   ALCMI-024 
 
An Observational Study to Evaluate the Incidence of Clinically Suspicious 
Lambert-Eaton Myasthenic Syndrome (LEMS) in Subjects Diagnosed with Small 
Cell Lung Cancer (SCLC) 
 
 
Issue Date(s): 12 June 2025 
Protocol Version: V1.0  
  
  
Sponsor Statement  
  
This protocol was subject to critical review and has been approved by the following persons:  
  
  
  
Jacob M. Sands, MD 
Thoracic Oncologist, Dana-Farber Cancer Institute (DFCI) 
 
 
Date  
  
Gilbert Youssef 
Neuro-Oncologist, Dana-Farber Cancer Institute (DFCI) 
 
Date  
  
 
 
 
 
 
  
 

 
 
 
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INVESTIGATOR SIGNATURE PAGE  
 
Study Protocol   ALCMI-024 
 
An Observational Study to Evaluate the Incidence of Clinically Suspicious 
Lambert-Eaton Myasthenic Syndrome (LEMS) in Subjects Diagnosed with Small 
Cell Lung Cancer (SCLC) 
 
 
Issue Date(s): 12 June 2025 
Protocol Version: V1.0  
 
Investigator Agreement 
I have read the above-Mentioned protocol and am aware of my responsibilities as Investigator 
for this trial.  As such, I agree to:  
• Personally supervise the conduct of this trial 
• Conduct the trial in accordance with International Conference on Harmonization E6 
Good Clinical Practice (ICH GCP) Consolidated Guidance, applicable regulatory 
requirements, and the protocol.  
• Comply with the procedures for data recording and reporting as required by the 
regulatory authorities and the Sponsor.  
• Permit monitoring, auditing and inspection of trial records as required by ICH GCP.  
• Retain the essential clinical trial documents as required by ICH GCP and the sponsor.  
 
The information contained in this protocol is proprietary and provided to me in confidence, and 
may not be disclosed to any other party, in any form, without prior authorization from the 
sponsor, except to the extent necessary for conduct of the trial.   
 
_________________________________________               _____________________ 
Investigator Signature  
 
 
 
 
 
Date 
 
 
_________________________________________ 
 
 
Investigator Name (Print) 

 
 
 
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SYNOPSIS 
Title of Study:  An Observational Study to evaluate the incidence of clinically suspicious Lambert-
Eaton Myasthenic Syndrome (LEMS) in subjects diagnosed with Small Cell Lung Cancer (SCLC)  
Investigational sites:  Up to 10 investigative sites; USA 
 
Study Phase (if applicable):  N/A observational study  
 
Study Objectives and Endpoints:   
Primary Objective(s):   
• 
Evaluate the incidence of clinically suspicious LEMS diagnosis in Subjects diagnosed with 
Small Cell Lung Cancer 
 
Secondary Objective(s):  
• 
Correlate the occurrence of clinically suspicious LEMS neurologic symptoms with VGCC 
antibody positivity.  
• 
Evaluate the occurrence of clinically suspicious LEMS with Small Cell Lung Cancer.  
• 
Evaluate the occurrence of clinically suspicious LEMS with Lung Cancer treatments received.  
• 
Record the number of subjects enrolled with a prior LEMS diagnosis. 
Study Rationale and Design: 
The incidence of LEMS associated with small cell lung cancer (SCLC) is described as about 3%, but 
population screening has not been evaluated. We hypothesize that the incidence of LEMS 
associated with SCLC is higher, and a screening test may help to better identify patients. We plan a 
multi-center testing of as many eligible patients as possible who present to clinic with small cell lung 
cancer. We will monitor testing every 3 months with documentation of any symptoms. Any workup 
will be done per standard of care.   
Number of Subjects per Cohort:   
Up to 400 subjects with SCLC  
Subject Population:   
Adult subjects meeting age of majority (AOM), with a diagnosis of SCLC will be enrolled. 
Test Product:   
N/A Observational Study   
Reference Product:  N/A 
Study Duration:   
Part A (est. 12 months): All subjects enrolled will have quarterly (Q 3 months) visits conducted during 
this initial 12-month period.  At around month 12, enrollment and study visits will be suspended and 
an interim analysis for futility will be performed to determine if the study will progress into Part B.   
 
Part B: The duration and sample size for Part B will be determined from the Part A interim analysis. 
Criteria for Evaluation:   
All enrolled subjects will be used for evaluation.  
Statistical Methods: A descriptive analysis of all data collected will be carried out.  
• 
At 1 year (12 months) an interim analysis for futility will be conducted.  

 
 
 
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1 INTRODUCTION 
 
1.1 Background 
 
Lambert-Eaton Myasthenic Syndrome (LEMS) is a rare auto-immune presynaptic disorder of 
the neuromuscular junction (NMJ) associated with proximal muscle weakness, reduced or 
absent muscle stretch reflexes, and autonomic dysfunction (PMID: 4330759). Up to 60% of 
cases occur in the setting of a paraneoplastic disorder, with small-cell lung cancer (SCLC) 
being the most common tumor type (PMID: 21245427; 2838124; 15277653). Antibodies (Ab) 
against voltage-gated calcium channels (VGCC), particularly of the P/Q type, are identified in 
85-90% of patients with LEMS (PMID: 9668336; 7739683; 9094058). Antibodies to N-type and 
L-type VGCC have also been reported in 25-40% of LEMS, concurrently with the P/Q-type 
antibodies, where (PMID: 8309586; 8583238), while few cases are seronegative. 
 
Awareness of the clinical features, diagnostic evaluation, malignancy workup, and 
management of LEMS, as well as a high index of suspicion, are important for timely diagnosis 
and proper treatment. When LEMS is suspected or diagnosed, the evaluation of a primary 
malignancy, particularly SCLC, is warranted due to the strong association. A diagnosis of 
SCLC has been established within 1 year of LEMS diagnosis in 96% of patients (PMID: 
18779614). Treatment of the underlying malignancy may be the only intervention necessary to 
improve neurologic symptoms.  
   
In the context of LEMS associated with SCLC, the median survival is approximately 18 
months. Median survival in individuals with SCLC and LEMS is better than those with only 
SCLC (median survival of 17 vs 7 months). This longer survival was seen in both limited SCLC 
(median survival of 19 vs 12.1 months) and extensive SCLC (13 vs 4.9 months). Individuals 
with non–tumor–associated LEMS have a similar life expectancy to the general population.  
 
 
1.2 Rationale 
 
LEMS is a paraneoplastic syndrome that occurs in about 3% of individuals with small cell lung 
cancer, whereas the prevalence of VGCC antibodies at the time of SCLC diagnosis is 
estimated around 7-8% of patients (PMID: 15904978; 19934775). However, the frequency of 
neurologic symptoms has not been thoroughly evaluated, neither has longitudinal serial 
assessment of VGCC antibodies throughout the SCLC disease course.  
This study aims at evaluating the incidence of LEMS in patients with SCLC at the time of their 
initial diagnosis, as well as at regular timepoints during their disease course. 
 
1.3 Overall Benefit/Risk Assessment 
 
This is an observational, non-treatment, non-interventional, non-randomized multi-center study 
in subjects who have been diagnosed with Small Cell Lung Cancer. No expected benefit or risk 
is anticipated for subjects participating in the study.  

 
 
 
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2 STUDY OBJECTIVES 
 
2.1 Primary Objective 
 
• To evaluate the incidence of clinically suspicious LEMS diagnosis in small cell lung cancer 
patients 
 
2.2 Secondary Objective(s) 
 
• To correlate the occurrence of clinically suspicious LEMS symptoms with VGCC antibody 
positivity  
• To evaluate the occurrence of clinically suspicious LEMS with SCLC 
• To evaluate the occurrence of clinically suspicious LEMS with Lung Cancer treatments 
received 
• Record the number of subjects enrolled with a prior LEMS diagnosis 
 
3 STUDY DESIGN AND EVALUATION 
3.1 Study Design 
 
This is a multi-center observational study in subjects with a diagnosis of small cell lung cancer. 
All eligible subjects enrolled will undergo a brief, symptom directed neurological evaluation and 
VGCC antibody testing (to be performed at a participating Quest laboratory). The results 
(positive/negative) of VGCC antibody testing will be documented as well as the receptor type 
P, Q or N.   
 
These tests will be repeated quarterly (Q3 months) for the duration of the study.  
 
If at any visit the subject is found to be BOTH neurologically suggestive of having LEMS and 
the VGCC Ab test is positive, then the subject is considered to be Clinically Suspicious of 
having LEMS. At any visit if a subject meets the criteria of Clinically Suspicious of LEMS. the 
end of study visit will be completed. Once the End of study visit is completed no further 
treatment information will be collected. 
 
There will be an Investigator Intended Course of Action Form to record possible course(s) of 
action taken for all subjects who meet the definition of clinically suspicious LEMS (have 
positive VGCC antibody and suspicious neurologic symptoms). A confirmatory diagnosis of 
LEMS is by electrophysiologic studies, including repetitive nerve stimulation and/or single fiber 
electromyography, in patients with suspicious neurologic symptoms and positive VGCC 
antibodies. This observational (only) trial will not involve any medical course of action as an 
outcome to testing or participation in this trial, and no adjustments to the subject’s existing 
treatment plan will result as an outcome to participation in this trial. Any treatment actions that 

 
 
 
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may be considered stemming from participation in this trial will not be considered as part of this 
observational study – and the intended course(s) of action only will be recorded in this trial.  
If a subject has been diagnosed with LEMS prior to enrollment in the study, the symptom 
directed neurological evaluation and VGCC Ab collection do not need to be completed.  The 
enrollment visit and End of study visit will be completed once all diagnosis information has 
been collected. No further follow up will be needed for this subject.   
 
This study is to be conducted in conformance with the International Conference on 
Harmonisation/Good Clinical Practices (ICH/GCP). 
 
3.1.1 Duration of Study 
 
Part A (est. 12 months): All subjects enrolled will have quarterly (Q 3 months) visits conducted 
during this initial 12-month period.  At around month 12, enrollment and study visits will be 
suspended and an interim analysis for futility will be performed to determine if the study will 
progress into Part B.   
 
Part B: The duration and sample size for Part B will be determined during from the Part A 
interim analysis. 
 
If the interim analysis for Part A determines that Part B will not be conducted, then the study 
will be closed and all study close out procedures completed.   
 
3.1.2 Screening / Enrollment  
 
Potential subjects will be reviewed against the inclusion/exclusion criteria to determine 
eligibility.  Small Cell Lung Cancer treatments received up to 30 days prior to enrollment will be 
collected. 
 
Subjects will be enrolled once eligibility is confirmed. 
 
3.1.3 Observation Period 
 
The observation period begins at enrollment (day 0). Subjects will be evaluated with a 
symptom directed neurological evaluation and given an order for a VGCC Ab test to be 
completed at Quest Laboratory. Both the Symptom directed neurological evaluation and VGCC 
Ab test will be completed every 3 months while the trial remains open.   
 
At each quarterly observation visit the following will be completed;  
• Review of disease progression and current cancer therapy 
• Complete the symptom directed neurological evaluation 
• VGCC Ab test  
o Results of positive/negative and receptor subtype (P, Q, or N) will be 
documented. 
 

 
 
 
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At month 12 of Part A, enrollment and study visits will be suspended for an interim analysis. 
 
3.1.4 Study Administration Structure 
 
Protocol ALCMI-024 is sponsored by ALCMI.  The administrative structure of the study is 
described in Table 4.1 Study Administrative Structure. 
 
 
Table 4.1  Study Administrative Structure.   
Group 
Responsibility 
Addario Lung Cancer Medical Institute (ALCMI)  
Provide scientific direction for the study.  Responsible for 
monitoring the progress of the study, data management, site 
monitoring, determining the need for modification of the 
protocol, publishing the results of the study.   
 
Quest Diagnostic Laboratories 
Collect, process and report the VGCC Ab test  
 
REDCap Database  
Electronic Data Capture for the study, Remote monitoring, and 
Datasets 
 
 
 
3.2 Study Population 
 
Adult subjects meeting age of majority with a diagnosis of SCLC will be evaluated for possible 
participation in the study. A goal of up to 400 SCLC subjects will be enrolled at approximately 
10 investigational sites. It is anticipated that each investigational site will enroll approximately 
40 SCLC subjects during Part A.  
 
Subjects must meet all of the inclusion criteria and none of the exclusion criteria to be enrolled 
in the study.  
 
3.3 Criteria for Evaluation 
 
All data collected will be included in the data evaluation.  
 
4 STATISTICICS 
 
4.1 Sample Size Determination 
 
The total target sample size will be up to 400 subjects. With an estimated 3% incidence of 
LEMS, which correlates with about 12 subjects to meet the definition of clinically suspicious of 
LEMS.  
 
 

 
 
 
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4.2 Data Set Descriptions 
 
The “observation period” refers to all data collected once the subject is enrolled and has 
completed at minimum one Symptom directed neurological evaluation and/or one VGCC 
antibody test. The symptom directed neurological evaluation and VGCC Ab tests will not be 
completed for any subject enrolled with a prior LEMS diagnosis. 
 
The data sets will consist of all data collected including all results of the symptom directed 
neurological evaluation and the VGCC antibody tests.  
 
The Intended Course of Action determined by the investigators will also be collected for all 
subjects who have an incidence of clinically suspicious LEMS diagnosis.  
 
4.3 Data Set Analyses 
   
Descriptive analysis of all data collected will be carried out. The study will explore correlations 
between all variables – including demographics, medical history, symptom directed 
neurological evaluation, VGCC Ab results, VGCC Ab subtypes identified, number of subjects 
enrolled with a prior LEMS diagnosis, number of subjects with an incidence of clinically 
suspicious LEMS diagnosis, and Intended Course of Investigator Action forms. An incidence of 
clinically suspicious LEMS diagnosis is defined as neurologic symptoms suggestive of having 
LEMS and positive VGCC Ab.  
 
4.3.1 Interim Analysis 
 
At approximately 1 year (12 months) after enrollment start, there will be an interim analysis for 
futility. After review of the data there will be a determination if the study will close or if Part B of 
the study will be designed and conducted.  
4.3.2 Safety Analyses 
 
This study is an observational and blood sample collection study that does not involve 
treatment safety analyses. 
 
5 Data Management 
 
Every effort will be made to ensure that data management practices adhere to international 
standardization of the following data management procedures.   
 
5.1 Database Design and Creation 
 
The REDCap database system will be used for this study. This database will be designed to 
store the data as recorded in the source and will ensure a one-to-one mapping between the 
source and the electronic case report form (CRF) stored in the system. 

 
 
 
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5.2 Data Coding 
 
Because this is a non-interventional, no treatment study, data coding is not required. 
 
5.3 Data Entry and Verification 
 
The data recorded on the protocol-unique source documents will be verified and entered into 
the REDCap trial database. 
 
5.4 Data Transfer 
 
Data transfers will be sent to Sponsor or their designee, electronically on a schedule and in a 
format mutually agreed upon by Sponsor or their designee, and the vendor responsible for the 
analysis of these data.   
 
5.5 Database Lock 
 
At around 12 months there will be a soft lock of the data for interim analysis. The interim 
analysis will determine if the study should be terminated or if Part B will be designed and 
conducted.  
 
On completion of the entire trial (Part A and Part B if it is continued), after data entry is 
complete and the data has been pronounced clean, the database will be locked and final write 
access will be removed. 
 
6 SUBJECT SELECTION AND DISCONTINUATION 
 
6.1 Inclusion 
 
Subjects must satisfy the following criteria before being enrolled into the study.  
 
1) 
Adult men or women meeting Age of Majority (AOM) at the time of consent  
2) 
Provide voluntary consent to participate in this study, documented via a signed 
informed Consent Form (ICF) 
3) 
Any diagnosis of SCLC 
4) 
Willing to provide clinical and medical information related to his/her cancer 
diagnoses to the study team as required 
5) 
Willing to comply with the requirements of the study 
 
 
 

 
 
 
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6.2 Exclusion 
 
A subject who meets any of the following exclusion criteria will be disqualified from 
participation in the study: 
 
1) 
Has been diagnosed with non-tumor Lamber-Eaton Myasthenic syndrome 
(LEMS) > 1 year prior to the SCLC diagnosis.  
2) 
Known existence of an uncontrolled intercurrent illness including, but not limited 
to, psychiatric illness or social situations that would impair compliance with study 
requirements 
 
Note: Concurrent enrollment in other clinical trials is NOT exclusionary 
 
6.3 Subject Discontinuation  
 
6.3.1 Subject Discontinuation Criteria 
 
Subject participation in the study may be prematurely discontinued for any of the following 
reasons: 
• Withdrawal of informed consent (subject’s decision and right to withdraw at any 
time for any reason); 
• Any abnormality or intercurrent illness, which in the opinion of the investigator, 
indicates that continued participation in the trial is not in the best interest of the 
subject; 
• Failure to comply with protocol requirements, evaluations, or other study 
parameters; 
• Subjects who become prisoners or become involuntarily incarcerated; 
• Termination of the study by Sponsor; 
• Lost to follow-up. 
 
6.3.2 Procedures for Discontinuation 
 
The reason for withdrawal or discontinuation will be documented in the CRF and source 
documents. If a subject chooses to withdraw from the study the reason or event must be 
captured in the CRF and source documents on the End of Study CRF.     
 
If a patient is lost to follow-up, a reasonable effort is required to contact the patient and perform 
the End of Study procedures. A reasonable effort is considered, at minimum, 3 phone attempts 
and/or 3 email attempts requesting patient to complete protocol requirements. The reason for 
withdrawal or discontinuation will be documented in the CRF and source documents. 
 
6.3.3 Replacement of Subjects 
 
Subjects who discontinue early will not be replaced in this study. 

 
 
 
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7 STUDY PROCEDURES AND OBSERVATIONS 
 
7.1 Time and Events Schedule (Flow Chart) 
 
Procedure 
Screening*  
Observation Period 
Enrollment 
Visit* 
Quarterly visit 
(Q 3 months) 
End of 
study 
Obtain Informed Consent 
X 
 
 
 
Review Inclusion/Exclusion Criteria 
X 
X 
 
 
Relevant Medical History 
X 
X 
 
 
SCLC diagnosis and treatment  
X 
X 
 
 
Demographics (Age, sex, 
Race/Ethnicity) 
 
X 
 
 
Review of disease progression and 
treatments 
 
 
X 
X 
Symptom Directed Neurological 
Evaluation 
 
X** 
X 
 
VGCC Ab blood collection 
 
X** 
X 
 
Investigator Intended course of 
Action Form (for clinically suspicious 
LEMS only) 
 
 
 
X 
* The screening and enrollment visit can be completed on the same day. 
**If the subject has a prior LEMS diagnosis at enrollment do not complete these activities and also complete the End 
of study visit. 
 
7.2 Procedures by Visit 
 
The investigator is responsible for adherence to the protocol. Prompt and complete reporting of 
all pertinent data is essential.  In order to minimize variability of evaluations, it is preferred that 
the same individuals perform the same or similar evaluations within each subject in the study. 
 
7.2.1 Screening Period* (Day -15 to Day 0) 
• Obtain written informed consent 
• Collect demographics (Age, sex, Race/Ethnicity) 
• Collect SCLC cancer diagnosis and treatment (up to 30 days prior to enrollment) 
• Collect relevant medical history, collect Medical History release form if needed 
• Review Inclusion/Exclusion criteria 
• Schedule Enrollment visit 
 
7.2.2 Enrollment visit* (Day 0)  
• Review inclusion/exclusion criteria 
• Review SCLC cancer diagnosis and treatment 
• Review of relevant medical history 
• Symptom directed neurological evaluation 

 
 
 
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• Provide Quest lab order for VGCC Ab collection 
• Schedule next observation visit in 3 months 
7.2.3 Quarterly Observational visits (Q 3 months) 
• Review SCLC disease progression and treatments 
• Symptom directed neurological evaluation 
• Provide Quest lab order for VGCC Ab collection 
• Schedule next observation visit in 3 months 
7.2.4 End of Study visit  
This visit will be conducted at any time a subject has met the definition of clinically 
suspicious LEMS, when a subject has completed 12 months of observation, or study 
terminated by sponsor. 
• Review SCLC disease progression and treatments  
• Document reason for end of study 
• Complete the Investigator Intended Course of Action form (Only complete for those 
subjects who met the definition of clinically suspicious LEMS). 
 
*The screening and enrollment visit can occur on the same day.  
7.3 Subject Assessments 
7.3.1 Demographics 
The demographics collected for this study will include subjects’ date of birth, subject initials, 
age, sex at birth, race and ethnicity 
7.3.2 SCLC Cancer diagnosis and Treatment, relevant medical history 
The SCLC date of diagnosis and any cancer treatments will be collected. Relevant medical 
history to confirm inclusion/exclusion criteria will be collected.  
 
If a subject has been diagnosed with LEMS prior to enrollment this will be documented in the 
subject’s medical history including the date of LEMS diagnosis, date of EMG and findings, and 
any LEMS treatment given.  
 
NOTE: If a subject has been diagnosed with LEMS prior to enrollment the symptom 
directed neurological evaluation and VGCC Ab collection will not be completed.  The 
enrollment visit and End of study visit will be completed once all diagnosis information 
has been collected. No further follow up will be needed for this subject.   
7.3.3 Symptom Directed Neurological Evaluation 
This evaluation will be administered by a delegated individual to make a determination of 
clinically suggestive or not clinically suggestive of having LEMS 
 

 
 
 
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If determined clinically suggestive of having LEMS the Investigator will complete the second 
part of the symptom evaluation to document the symptoms present. 
 
If the subject’s neurologic symptoms are suggestive of having LEMS the investigator will 
review to see if the VGCC antibody test was positive. If the subject is BOTH neurologically 
suggestive of having LEMS and the VGCC Ab test is positive, then the subject is considered 
as Clinically Suspicious of having LEMS and the end of study visit completed.  
7.3.4 VGCC Antibody Blood draw 
At each observation visit the subject will be provided an order for a VGCC antibody blood test, 
to be collected within 15 days of the visit, at the Quest Diagnostic Laboratory of their 
convenience.  Quest will report the lab results to the Investigator.  The results of positive or 
negative and any indicated subtype will be documented for the subject 
 
If a positive result is found the Investigator will review if the subject has a clinically suggestive 
symptom directed neurological evaluation. If the subject is BOTH neurologically suggestive of 
having LEMS and the VGCC Ab test is positive, then the subject is considered as Clinically 
Suspicious of having LEMS and the end of study visit completed.   
 
7.3.5  Investigator Course of Action Form  
The investigator course of action will be completed to document what actions the investigator 
will take for each subject who is considered clinically suspicious of having LEMS.   
 
At any visit if a subject is considered clinically suspicious of LEMS. the end of study visit will be 
completed. Once the End of study visit is completed no further treatment information will be 
collected. 
 
8 INVESTIGATIONAL PRODUCT 
 
Not Applicable as this is an observational study. 
 
9 ADVERSE EVENT REPORTING IN CLINICAL TRIALS 
Adverse events are not expected in this study, as the only change in patient care mandated by 
this protocol is an additional collection of blood. There may be a small risk of bruising or 
hematoma from the taking of the peripheral blood due to the needle stick, as well as a slight 
risk of fainting.  However, any other evaluations (imaging, physical assessment, etc.) are 
considered to be standard of care in the evaluation of patients with lung cancer and would be 
performed as part of the standard of care clinical work-up, not for the purpose of this study. 
 

 
 
 
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10 QUALITY ASSURANCE 
 
10.1 Compliance with Protocol and Protocol Revisions 
 
The study shall be conducted as described in this approved protocol.  All revisions to the 
protocol must be discussed with, and be prepared by, Sponsor or designee.  The Investigator 
should not implement any deviation or change to the protocol without prior review and 
documented approval/favorable opinion from the IRB/IEC of an Amendment, except where 
necessary to eliminate an immediate hazard(s) to study subjects.  Any significant deviation 
must be documented.   
 
If a deviation or change to a protocol is implemented to eliminate an immediate hazard(s) prior 
to obtaining IRB/IEC approval/favorable opinion, as soon as possible the deviation or change 
will be submitted to: 
• IRB/IEC for review and approval/favorable opinion; 
• Sponsor; 
• Regulatory Authority(ies), if required by local regulations. 
 
Documentation of approval signed by the chairperson or designee of the IRB(s)/IEC(s) must 
be sent to Sponsor. 
 
If an Amendment substantially alters the study design or increases the potential risk to the 
subject: (1) the consent form must be revised and submitted to the IRB(s)/IEC(s) for review 
and approval/favorable opinion; (2) the revised form must be used to obtain consent from 
subjects currently enrolled in the study if they are affected by the Amendment; and (3) the new 
form must be used to obtain consent from new subjects prior to enrollment. 
 
10.2  Monitoring for Protocol Compliance 
 
Representatives of Sponsor must be allowed to visit all investigational site locations in person 
or remotely to periodically to assess the date, quality and study integrity.  During these visits 
they will review study records in comparison with source documents, discuss the conduct of 
the study with the Investigator, and verify that the facilities remain acceptable.   
 
In addition, the study may be evaluated by Sponsor internal auditors and government 
inspectors who must be allowed access to CRFs, source documents and other study files.  
Sponsor audit reports will be kept confidential. 
 
Deviations to the protocol shall be recorded and reported to Sponsor and/or IRB as applicable.  
 
THE INVESTIGATOR MUST NOTIFY SPONSOR PROMPTLY OF ANY INSPECTIONS 
SCHEDULED BY REGULATORY AUTHORITIES, AND PROMPTLY FORWARD COPIES OF 
INSPECTION REPORTS TO SPONSOR. 
 

 
 
 
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11 ETHICAL AND LEGAL CONSIDERATIONS 
 
11.1  Institutional Review Board/Independent Ethics Committee (IRB/IEC) 
 
Before study initiation, the Investigator must have written and dated approval/favorable opinion 
from the IRB/IEC for the protocol, informed consent form, subject recruitment 
materials/process (e.g., advertisements), and any other written information to be provided to 
subjects.  The IRB/IEC approval/favorable opinion should be obtained in writing, clearly 
identifying the trial, the documents reviewed, and the date of the review.   
 
As appropriate, amendments to the above stated documents must also be submitted and 
receive approval/favorable opinion from the IRB/IEC prior to implementation at the 
investigational site. The IRB/IEC approval/favorable opinion should be obtained in writing, 
clearly identifying the trial, the documents reviewed, and the date of the review.   
 
The Investigator or Sponsor should also provide the IRB/IEC with a copy of the Investigator 
Brochure and/or product labeling, reports, updates and other information according to 
regulatory requirements or Institution procedures. 
 
11.2  Informed Consent 
 
Investigators must ensure that subjects or their legally acceptable representative are clearly 
and fully informed about the purpose, potential risks and other critical issues regarding clinical 
trials in which they volunteer to participate. 
 
The following sections contain Sponsor procedures on obtaining informed consent from 
subjects or their legally acceptable representative prior to participating in a clinical trial.  
Procedures are described for all subjects, including those who are unable to give informed 
consent.  The relevant procedures must be used whenever they are applicable. 
 
11.2.1 
Informed Consent Procedures 
Preparation of the consent form is the responsibility of the Investigator and must include all 
elements required by ICH, GCP and applicable regulatory requirements, and must adhere to 
GCP and to the ethical principles that have their origin in the Declaration of Helsinki.  The 
consent form must also include a statement that Sponsor and regulatory authorities have direct 
access to subject records.  Prior to the beginning of the study, the Investigator must have the 
IRB/IEC’s written approval/favorable opinion of the written informed consent form and any 
other information to be provided to the subjects. 
 
The Investigator must provide the subject or legally acceptable representative with a copy of 
the consent form and written information about the study in the language in which the subject 
is most proficient.  The language must be non-technical and easily understood.  The 
investigator should allow time necessary for subject or subject’s legally acceptable 
representative to inquire about the details of the study, then informed consent must be signed 

 
 
 
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and personally dated by the subject or the subject’s legally acceptable representative and by 
the person who conducted the informed consent discussion. The subject or legally acceptable 
representative should receive a copy of the signed informed consent and any other written 
information provided to study subjects prior to subject’s participation in the trial. 
 
11.2.2 
Subjects Unable to Give Informed Consent 
Patients must be able to provide consent to be included in this study. 
 
11.2.2.1 
Minors 
Not applicable to this study. 
 
11.2.2.2 
Patients Experiencing Acute Events or Emergencies 
Not applicable to this study. 
 
11.2.2.3 
Mentally Impaired or Incapacitated Subjects 
Investigators should determine whether or not a mentally impaired or incapacitated subject is 
capable of giving informed consent and should sign a statement to that effect.  If the subject is 
deemed mentally competent to give informed consent, the investigator should follow standard 
procedures.  If the subject is deemed not to be mentally competent to give informed consent, a 
fully informed legal guardian or legally acceptable representative can be asked to give consent 
for, or on behalf of, the subject.  All local laws, rules and regulations regarding informed 
consent of mentally impaired or incapacitated subjects must be followed. 
 
11.2.2.4 
Other Circumstances 
Imprisonment or the compulsory detention for treatment of either a psychiatric or physical (e.g., 
infections disease) illness must not be enrolled in clinical trials. 
 
In circumstances where a subject’s only access to treatment is through enrollment in a clinical 
trial (e.g., for subjects in developing countries with limited resources or for subjects with no 
marketed treatment options), the investigator must take special care to explain the potential 
risks and benefits associated with the trial and ensure that the subject is giving informed 
consent. 
 
Relatives of the investigator or the study staff must not be enrolled in the clinical trial.   
 
11.2.3 
Illiterate Subjects 
If the subject or legally acceptable representative is unable to read, a reliable and independent 
witness should be present during the entire informed consent discussion.  The choice of the 
witness must not breach the subject’s rights to confidentiality.  A reliable independent witness 
is defined as one not affiliated with the institution or engaged in the investigation.  A family 
member or acquaintance is appropriate independent witnesses.  After the subject or legally 
acceptable representative orally consents and has signed, if capable, the witness should sign 
and personally date the consent form attesting that the information is accurate and that the 

 
 
 
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subject or legally acceptable representative has fully understood the content of the informed 
consent agreement and is giving true informed consent.  
 
11.2.4 
Update of Informed Consent 
The informed consent and any other information provided to subjects or the subject’s legally 
acceptable representative, should be revised whenever important new information becomes 
available that is relevant to the subject’s consent, and should receive IRB/IEC 
approval/favorable opinion prior to use.  The Investigator, or a personal designated by the 
Investigator should fully informed the subject or the subject’s legally acceptable representative 
of all pertinent aspects of the study and of any new information relevant to the subject’s 
willingness to continue participation in the study.  This communication should be documented. 
 
11.3  Confidentiality 
 
11.3.1 
Confidentiality of Data 
By signing this protocol, the investigator affirms to Sponsor that information furnished to the 
investigator by Sponsor will be maintained in confidence and such information will be divulged 
to the Institutional Review Board, Ethical Review Committee, or similar or expert committee, 
affiliated institution, and employees only under appropriate understanding of confidentiality with 
such board or committee, affiliated institution and employees. Data generated by this study will 
be considered confidential by the investigator, except to the extent that it is included in a 
publication as provided in Section 12.4.  
 
11.3.2 
Confidentiality of Patient Records 
The confidentiality of records that could identify subjects must be protected, respecting the 
privacy and confidentiality rules in accordance with the applicable regulatory requirement(s).  
By signing this protocol, the investigator agrees that Sponsor (or Sponsor representative), 
Institutional Review Board/Independent Ethics Committee (IRB/IEC), or Regulatory Agency 
representatives may consult and/or copy study documents in order to verify Case Report Form 
data. By signing the consent form, the subject agrees to this process. If study documents will 
be photocopied during this process of verification, the subject will be identified by unique code 
only; full name/initials and other personal identifiers will be masked. 
 
11.3.3 
Confidentiality of Investigator Information 
By signing this protocol, the investigator recognizes that certain personal identifying 
information (e.g., name, hospital or clinic address, curriculum vitae) may be made part of a 
regulatory submission and may be transmitted (either in hard copy or electronically) to Sponsor 
for internal study management purposes or as required by individual regulatory agencies. 
Additionally, the investigator’s name, hospital/clinic address/phone number may be included 
when reporting certain SAEs to regulatory agencies or to other investigators and stored in 
managed regulatory-controlled databases such as REDCap. 
 
11.4  Publications and Other Rights 
 

 
 
 
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Manuscript(s) and abstract(s) will be prepared through cooperation between Sponsor and the 
study investigator(s). 
 
11.4.1.1 
Responsibilities 
The principal investigator has the right to publish or publicly present the results of the study in 
accordance with this section of the protocol. In the event that the Protocol is part of a multi-
center study, it is understood that it is the intent of Sponsor and the principal investigator to 
initially only publish or present the study results together with the other investigational sites, 
unless specific written permission is obtained in advance from Sponsor to publish separate 
results. Sponsor shall advise as to the implications of timing of any publication in the event 
clinical trials are still in progress at investigational sites other than that of the principal 
investigator’s. 
 
The principal investigator agrees not to publish or publicly present any interim results of the 
Study without prior written consent of Sponsor. The principal investigator further agrees to 
provide 45 days written notice to Sponsor prior to submission for publication or presentation to 
permit Sponsor to review copies of abstracts or manuscripts for publication (including, without 
limitation, slides and text of oral or other public presentations and text of any transmission 
through any electronic media, e.g., any computer access system such as the Internet, World 
Wide Web, etc.) which report any results of the Study. Sponsor shall have the right to review 
and comment on any presentation, which shall include editorial rights to: 
 
(i) ensure that proprietary information is protected by the provisions contained in 
Section B below; 
(ii) ensure the accuracy of the information contained in the presentation; and 
(iii) ensure that the Public Presentation is fairly balanced as required by, and otherwise 
in compliance with, FDA Regulations. 
 
If the parties disagree concerning the appropriateness of the data analysis and presentation, 
and/or confidentiality of Sponsor’s confidential information, the principal investigator agrees to 
meet with Sponsor’s representatives at the clinical investigational site or as otherwise agreed, 
prior to submission of presentation for publication, for the purpose of making good faith efforts 
to discuss and resolve any such issues or disagreement. 
 
11.4.1.2 
Patents 
No publication or manuscript shall contain any trade secret information of Sponsor or any 
proprietary or confidential information of Sponsor and shall be confined to new discoveries and 
interpretations of scientific fact. If Sponsor believes there is patentable subject matter 
contained in any publication or manuscript submitted for review, Sponsor shall promptly 
identify such subject matter to principal investigator. If Sponsor requests and at Sponsor’s 
expense, Principal Investigator shall use his/her best efforts to assist Sponsor to file a patent 
application covering such subject matter with the US Patent and Trademark Office or through 
the Patent Cooperation Treaty prior to any publication. 
 

 
 
 
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11.4.1.3 
Right to Use 
The principal investigator is granted the right to use the results of all work provided by principal 
investigator under this Protocol, including but not limited to, the results of tests and any raw 
data and statistical data generated for principal investigator’s own teaching, research and 
publication purposes only. Principal investigator/institution agrees, on behalf of itself and its 
employees, officers, trustees, and agents, not to cause said results to be knowingly used for 
any commercial purpose whatsoever except as authorized by Sponsor in writing. 
 
12 ADMINISTRATIVE 
 
12.1 Records and Reports 
 
An Investigator is required to prepare and maintain adequate and accurate case histories 
designed to record all observations and other data pertinent to the investigation on each 
individual treated with the investigational product or entered as a control in the investigation.  
Data reported on the CRF, that are derived from source documents, must be consistent with 
the source documents or the discrepancies must be explained. Corrections to source 
documents must be made by striking through the incorrect entry with a single line and entering 
the correct information adjacent to the incorrect entry.  The correction must be initialed and 
dated by the person making the correction and must not obscure the original entry.  The 
source documents may further provide an explanation for the change, if necessary. 
 
The eCRF must be completed within one week of subject visits.  All requested information 
must be entered on the eCRF.  If an item is not available or is not applicable, it must be 
documented as such; do not leave a space blank. 
 
The Investigator will maintain a Site Signature and Delegation of Duties Log to document 
signatures and initials of all persons authorized to make entries and/or corrections on the 
eCRFs.  
  
12.2 Records Retention 
 
The investigator must maintain copies of all documents and records related to the conduct of 
the trial (such as investigational product disposition records, copies of CRFs (or electronic 
files), and source documents, etc.) for the maximum period required by applicable regulations 
and guidelines, or Institution procedures, or for the period specified by Sponsor.   
 
If the Investigator wishes to relocate the records or is unable to retain them for the specified 
retention period, Sponsor must be contacted and notified in writing. 
 
If the Investigator withdraws from the study (e.g., relocation, retirement) the records shall be 
transferred to a mutually agreed upon designee (e.g., another Investigator, IRB).  Sponsor 
must be notified in writing of any such transfer.   
 

 
 
 
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All trial documents shall be made available if required by relevant health authorities.  The 
Investigator must contact Sponsor prior to destroying any records associated with the study. 
 
12.3 Sponsor 
 
Sponsor of this study is: 
 
Addario Lung Cancer Medical Institute (ALCMI) 
1100 Industrial Rd, Suite 1 
San Carlos, CA  94070 
 
12.4 Investigators, Investigational Sites and IRBs 
 
Only investigators qualified by training and experience to perform a clinical investigation are 
selected.  Sponsor or designee will contact and select all principal investigators (legally 
responsible party(ies) at each investigational site), who, in turn, will select their staff.  
 
A list of active Investigator names, sub-investigator names, Institution names/ addresses and 
reviewing IRBs names/addresses is maintained by Sponsor, external to the protocol.   
 
12.5 Central Organizations and/or Vendors 
 
A list of names and addresses of organizations and/or vendors involved in patient 
management and associated testing and analysis where it affects the validity of the 
investigation is maintained by Sponsor, external to the protocol 

 
 
 
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13 LIST OF ABBREVIATIONS 
 
Term 
Definition 
AE 
Adverse event 
ALCMI 
Addario Lung Cancer Medical Institute 
AOM 
Age of Majority 
CDMS 
Clinical Data Management System 
CRF 
Case Report Form  
CRO 
Clinical Research Organization 
CSR 
Clinical Study Report 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
EMG 
Electromyography 
ICH/GCP 
International Conference on Harmonisation / Good Clinical Practices 
HIPAA 
The Health Insurance Portability and Accountability Act of 1996  
Hx 
History 
IRB/IEC 
Institutional Review Board / Independent Ethics Committee 
kg 
Kilogram 
LEMS 
Lambert-Eaton myasthenic syndrome 
Q3m 
Every three months 
SCLC 
Small Cell Lung Cancer 
VGCC Ab 
Voltage-gated calcium channel antibody test 
 

 
 
 
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14 REFERENCES  
 
Jayarangaiah, A., Lui, F., & Kariyanna, P. T. (2023, October 23). Lambert-Eaton Myasthenic Syndrome. 
NCBI Bookshelf, National Library of Medicine, National Institutes of Health: StatPearls 
Publishing. 
Lambert-Eaton Myasthenic Syndrome (LEMS) - Diseases . (2025). Retrieved from Muscular Dystorphy 
Association : https://www.mda.org/disease/lambert-eaton-myasthenic-syndrome 
Matthew C. Varon, M., & Mazen M. Dimachkie, M. (2024). Diagnosis and Treatment of Lambert-Eaton 
Myasthenic Syndrome. Autoimmune Neruomuscular Diseases, 26-28, 47. 

 
 
 
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15  Appendices 
15.1  Appendix 1:  Quest Lab order 
 
 

 
 
 
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15.2  Appendix 2: LEMS Symptom Directed Neurological Evaluation 
 
 
 
 
 

 
 
 
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15.3  Appendix 3: Investigator Course of Action Form