Clinical trial NCT03344861
Conditions: Lung Cancer Lung Cancer Metastatic
Keywords: lung cancer lung carcinoma lung metastases
Sponsor: Concordia Laboratories Inc.
Start date: 2017-08-14; Completion date: 2019-03-22
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This research study is being conducted to assess the safety of PDT in subjects with peripherally located malignant tumors in lung parenchyma prior to surgical resection. It will involve up to 10 sites in USA. Participation will last 4 months.

Detailed description:
Lung cancer accounts for almost one-third of cancer deaths. Cancer screening strategies have the potential to achieve a 20% reduction in death rates. Newly developed bronchoscopic technologies (such as navigational bronchoscopy) have been shown to enable physicians to safely reach lesions in peripheral regions of the lung and obtain diagnosis. This new technology may now potentially offer bronchoscopic therapeutic interventions, such as photodynamic therapy, to tumors that were previously unreachable due to their peripheral anatomic location.

Photodynamic therapy (PDT) uses a combination of a photosensitizing drug (a drug that is activated by light), called porfimer sodium (Photofrin®), and a light from a laser that emits no heat. This technique works to allow the medical doctor to specifically target and destroy abnormal or cancer cells while limiting damage to surrounding healthy tissue. The activation of the drug is done by lightning the abnormal area using a fiber optic device (very fine fiber \[like a fishing line\] that permits light transmission) inserted into a flexible tube with a light, called bronchoscope for the lung. The light activates the porfimer sodium concentrated in the abnormal tissue, leading to its destruction.

The purpose of this study is to assess the safety of using photodynamic therapy prior to surgical resection of tumors located in the periphery of the lung.

Arms: arm 1: Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.
Interventions: intervention 1: Porfimer Sodium intervention 2: Fiber optic
Intervention descriptions: intervention 1: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg. intervention 2: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.

Protocol documents:
Prot_000.pdf: 
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SAP_001.pdf: 


Concordia Laboratories Inc. 
Confidential 
Statistical Analysis Plan  
Study Code CLI-PHO1701 
Version Final  
Date Apr 10, 2018 
2 
TABLE OF CONTENTS 
PAGE 
 
TITLE PAGE ............................................................................................................................ 1 
TABLE OF CONTENTS ......................................................................................................... 2 
LIST OF ABBREVIATIONS .................................................................................................. 4 
1. 
INTRODUCTION ................................................................................................... 5 
2. 
STUDY DETAILS ................................................................................................... 5 
2.1 
Study Objectives ...................................................................................................... 5 
2.1.1 
Primary Objective .................................................................................................... 5 
2.1.2 
Secondary Objective ................................................................................................ 5 
2.2 
Study Design ............................................................................................................ 5 
2.2.1 
Schedule of visits ..................................................................................................... 6 
3. 
DATA ANALYSIS CONSIDERATIONS .............................................................. 6 
3.1 
Determination of Sample Size ................................................................................. 6 
4. 
PRIMARY AND SECONDARY ENDPOINTS ..................................................... 7 
4.1 
Primary Endpoints.................................................................................................... 7 
4.2 
Secondary Endpoints................................................................................................ 7 
5. 
STATISTICAL METHODOLOGY ........................................................................ 8 
5.1 
General Considerations ............................................................................................ 8 
5.2 
Analysis Populations ................................................................................................ 8 
5.2.1 
Intent-to-Treat Population ........................................................................................ 9 
5.2.2 
Safety Population ..................................................................................................... 9 
5.3 
Coding Dictionaries Used ........................................................................................ 9 
5.4 
Analysis Methods ..................................................................................................... 9 
5.4.1 
Study Subjects Disposition ...................................................................................... 9 
5.4.2 
Demographic and Baseline Characteristics.............................................................. 9 
5.4.3 
Medical History........................................................................................................ 9 
5.4.4 
Primary Diagnosis and Oncology History ............................................................. 10 
5.4.5 
Protocol Deviations ................................................................................................ 10 
5.4.6 
Photofrin® Injection ............................................................................................... 10 
5.4.7 
Photodynamic therapy............................................................................................ 10 
5.4.8 
Surgery ................................................................................................................... 10 
5.4.9 
Tumor and Healthy Tissue Response Analysis...................................................... 10 
5.4.10 
ECOG Performance Status..................................................................................... 10 
5.4.11 
Safety Analysis ...................................................................................................... 10 


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5.4.11.1 Adverse Events ...................................................................................................... 10 
5.4.11.2 Clinical Laboratory Parameters ............................................................................. 11 
5.4.11.3 Physical Examination ............................................................................................. 12 
5.4.11.4 Vital Signs .............................................................................................................. 12 
5.4.11.5 Prior and Concomitant Medications ...................................................................... 12 
5.4.11.6 Adjunctive Therapy/Procedures ............................................................................. 13 
5.4.12 
Chest X-ray ............................................................................................................ 13 
5.4.13 
Other Assessments ................................................................................................. 13 
6. 
CHANGES IN ANALYSIS FROM PROTOCOL ................................................ 13 
7. 
REFERENCES....................................................................................................... 14 
8. 
APPENDICES ....................................................................................................... 15 
 
LIST OF TABLES 
Table 1 
Study Schedule ......................................................................................... 15 
 


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LIST OF ABBREVIATIONS 
Abbreviation  
Definition  
AE  
Adverse Event  
AESI 
Adverse Event of Special Interest 
ATC 
Anatomic-therapeutic-chemical 
β-hCG 
β human chorionic gonadotropin 
BMI  
Body mass index  
CL 
Confidence limit 
CRF 
Case Report Form 
CT 
Computed Tomography 
CTCAE 
Common Terminology Criteria for 
Adverse Events 
ECG  
Electrocardiogram  
ECOG 
Eastern Cooperative Oncology Group 
ITT 
Intent-to-Treat 
IV  
Intravenous 
MedDRA  
Medical Dictionary for Regulatory 
Activities  
nm 
nanometer 
PDT 
Photodynamic therapy 
PHO 
Photofrin® 
RFA 
Radiofrequency ablation 
SAE  
Serious adverse event  
SAP 
Statistical analysis plan 
SOC  
System organ class  
TEAE  
Treatment-emergent adverse event  
WHO 
World Health Organization 
 


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1. 
INTRODUCTION 
The purpose of this statistical analysis plan (SAP) is to provide all details and specifications 
for the analysis of the study CLI-PHO1701, "A Multicenter, Prospective, Open-Label, Non-
Randomized Single-Arm Clinical Study of the Safety and Tissue Response to Photodynamic 
Therapy Using Porfimer Sodium for Injection as Treatment for Solid Lung Tumor Prior to 
Surgical Resection" as set forth in the clinical study protocol version 1 dated Mar 01, 2017.  
2. 
STUDY DETAILS 
2.1 
Study Objectives 
2.1.1 
Primary Objective 
The primary objective of this study is to assess the safety of photodynamic therapy (PDT) in 
subjects with solid tumors in peripheral lung prior to surgical resection.  
2.1.2 
Secondary Objective 
The secondary objective of this study is to assess the lung tumor and healthy tissue response to 
PDT. 
2.2 
Study Design 
This is a prospective, multicenter, uncontrolled, non-randomized, open-label, clinical study 
with the primary objective to assess safety of PDT in subjects with peripherally located 
malignant tumors in lung parenchyma prior to surgical resection. A Time and Procedures 
Schedule for the overall conduct of the study is outlined in section 8. 
The primary diagnosis will be performed as per standard of care no more than 60 days prior to 
consent signature. Upon signing consent, subjects will be assigned a unique participation 
number and will undergo screening evaluation conducted during the 30 days prior to 
enrollment. This phase will involve medical evaluations and thorough review of all reports 
that led to the primary diagnosis. Upon successful screening evaluations, subjects will be 
enrolled into the study. 
Treatment Procedures will consist of one PDT-Photofrin® course performed through 
navigational bronchoscopy or peripheral ultrasound guided bronchoscopy. One course will 
consist of an intravenous (IV) injection of Photofrin® (PHO) 2 mg/kg over 3-5 minutes 
followed by one laser light application session. The end of injection will be Study Hour 0. 
Photodynamic laser therapy will be performed on Study Hour 40-50. Laser light (630 nm 
wavelength) will be applied at a dose of 200 J/cm of the diffuser length. 
Ten to 15 days after PDT, subjects will undergo surgery as per standard of care. Macroscopic 
and microscopic examinations of the tumor and surrounding healthy lung tissue will be 
evaluated to determine the effect of PDT on the tumor and the healthy/non-tumor lung tissue. 
Macroscopic examinations will be performed at the local institution. Microscopic 
examinations will be performed by a central reader pathologist. 


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Follow-up assessments will include some or all the following procedures: physical exam; vital 
signs evaluation; body weight measurement; chest CT; chest X-ray; performance status; and 
clinical laboratory testing. All subjects will be asked general questions about the occurrence of 
adverse events, concurrent medical conditions, use of adjunctive therapy/procedure, and 
intake of concomitant medication. 
Data will be analyzed to evaluate the safety of the modality up to 90 days post-surgery. 
2.2.1 
Schedule of visits 
Pre-treatment assessments will be performed during the 30 days prior to enrolment. After 
enrolment, study visits will be as follows: 
• Study Day 0 will be the day the subject is enrolled. 
• Study Day 1 will be the day of the PHO injection. Study Hour 0 will be the time of the 
end of PHO injection. 
• Study Day 3 will be the day of PDT. Study Hour 40-50 will be calculated from Study 
Hour 0. 
• Study Day 5 will be the day of hospital discharge. Subjects will be discharged from the 
48-hour hospital stay after the Chest X-ray and other safety evaluations indicating that 
the subject is stable and able to be discharged; otherwise, the subject’s hospital stay 
may be extended to 72 hours or until the subject is stable for discharge 
• Study Day 13 to Day 18 will be the time-period where the surgery will be performed 
post PDT. 
• Study Day 20 to Day 25 (±2 days) will be the 7-day post-surgery visit. 
• Study Day 43 to Day 48 (±3 days) will be the 30-day post-surgery visit. 
• Study Day 103 to Day 108 (±7 days) will be the 90-day post-surgery last study visit. 
3. 
DATA ANALYSIS CONSIDERATIONS 
3.1 
Determination of Sample Size 
This study is designed to assess the safety of PDT in subjects with solid lung tumors prior to 
surgical resection and to assess the lung tumor and healthy tissue response to PDT. The intent 
of this study is to enroll 10 subjects. This sample size has the following precision for 
estimation of rates of AE's of special interest (AESI). The following table shows historical AE 
rates for RFA ranging from <1 to ~50%. 
AESI 
Rate Observed with RFA 
Pneumothorax  
11-52% 
Pleural effusion  
6-19% 
Hemorrhage  
6-18% 
Pulmonary artery pseudoaneurysm  
0.2% 
Needle tract seeding  
0.3-0.7% 
Cavitation  
14% 
Bronchopleural fistula  
0.6% 
Pneumonitis  
0.4% 


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The sample size of N=10 has precision for estimation of AE rates for estimates ranging from 
<0.01 to ~0.5 as shown in the following list. Precision is measured by 1-sided 95% upper 
confidence limit (CL) on the estimated AE rate via exact binomial distribution. PDT is 
expected to have lower AE rates than RFA, so, for example, for a RFA historical rate of 0.27 
(27%), if no such AE's are observed on PDT, then the TRUE underlying PDT rate is lower 
than 0.27 with 95% confidence since the upper 95% CL is 0.26 - indicated by "*" in the list 
below. 
No. of AESIs 
Rate 
Upper 1-sided 95% confidence limit 
0  
0.00  
0.26* 
1  
0.10  
0.39 
2  
0.20  
0.51 
3  
0.30  
0.61 
4  
0.40  
0.70 
5  
0.50  
0.78 
 
The study will be suspended and re-evaluated from a safety standpoint if 20% of the subjects 
experience a serious adverse event that is related to PDT. 
4. 
PRIMARY AND SECONDARY ENDPOINTS 
4.1 
Primary Endpoints 
The primary endpoints are safety assessments: 
• incidence of adverse events and serious adverse events 
• laboratory data 
• physical examination 
• vital signs 
• concomitant medication 
4.2 
Secondary Endpoints 
Secondary endpoints will include: 
• Tumor destruction and cell death in area of the PDT (0.75 cm radius if the laser fiber is 
eccentrically placed, or 1.5 cm diameter if the laser fiber is centrally placed) as defined 
by cytological and pathological evaluation. 
• Effect of PDT on the non-cancerous lung tissue surrounding the targeted tumor. 


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5. 
STATISTICAL METHODOLOGY 
5.1 
General Considerations 
All statistical evaluations will be conducted using SAS® version 9.4 or higher (SAS® Institute, 
Cary, North Carolina).  All tables, figures and listings will be produced in landscape format.  
In general, all data will be listed by subject and visit/time point where appropriate. The total 
number of subjects under the stated population (N) will be displayed in the header of summary 
tables. 
Data will be summarized using descriptive statistics for continuous variables. Unless otherwise 
specified, descriptive statistics will include number of subjects, mean, standard deviation, 
minimum, median and maximum. In case of n<2, where n indicates the number of evaluable 
subjects at the particular time point, the standard deviation will be empty. The statistic 
“Missing” will also be presented as the number of missing entries/subjects, if any at that 
visit/timepoint, and presented as a summary statistic only when non-zero. The minimum and 
maximum statistics will be presented to the same number of decimal places as the original data. 
The mean and median will be presented to one more decimal place than the original data, 
whereas the standard deviation will be presented to two more decimal places than the original 
data.  
In summary tables of categorical variables, counts and percentages will be used. The count [n] 
indicates the actual number of subjects with a particular value of a variable or event, which 
should always be less than or equal to the total number of subjects with non-missing value of 
the variable or event [M]. Percentage will be obtained by: % = (n/M)*100. Unless otherwise 
stated, all percentages will be expressed to one decimal place. 
In by-visit summary tables only scheduled visits/timepoints will be summarized. In listings all 
visits and timepoints with any data collected, including both scheduled and unscheduled ones 
and early termination visits, will be included. 
The closest non-missing measurement (whether from scheduled or unscheduled visit) taken 
prior to the administration of the study drug (PHO) will be considered as the baseline value. 
The change from baseline values will be derived for each subject as the post-baseline evaluation 
minus the baseline evaluation. 
Study days will be calculated as the number of days from the date of the study drug 
administration: 
Study Day = (Target Date - Date of the study drug administration) + 1 if target date is greater 
than or equal to the date of the study drug administration or 
Study Day = (Target Date – Date of the study drug administration) if target date is less than 
date of the study drug administration. 
All dates will be displayed in DD/MMM/YYYY format. 
5.2 
Analysis Populations 
The analysis populations defined in this study are as follows: 


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5.2.1 
Intent-to-Treat Population 
The Intent-to-Treat (ITT) Population will be defined as all enrolled subjects. 
5.2.2 
Safety Population 
The Safety Population will be defined as all enrolled subjects who received the Photofrin® 
injection. 
5.3 
Coding Dictionaries Used  
Adverse event and medical history verbatim terms provided by the investigator will be coded 
using the Medical Dictionary for Drug Regulatory Affairs (MedDRA, version 20.0). The 
resultant primary system organ class and preferred term will be used for AE summaries.  
Prior and concomitant medication generic terms provided by the investigator will be coded 
according to WHO Drug Dictionary September-2016 B2 and classified by preferred terms and 
ATC classes. The highest available ATC class and preferred term will be used for prior and 
concomitant medication summaries and listings. 
5.4 
Analysis Methods 
5.4.1 
Study Subjects Disposition  
Subject disposition will be summarized by presenting the number of subjects who were enrolled, 
were included into the ITT and safety populations, received PDT, underwent planned surgery, 
completed the study and prematurely discontinued with breakdown by the reason for early 
discontinuation. The analysis will be based on all enrolled subjects.  
A listing will be presented to describe whether the subject completed the study, date of 
completion or early withdrawal, and the reason for early discontinuation, if applicable. A listing 
will also be provided to describe if the subject meets all inclusion/exclusion criteria. The reason 
for entry criteria violation, if any, will be presented.  
5.4.2 
Demographic and Baseline Characteristics 
Demographic and baseline characteristics such as age, sex, childbearing potential (for female 
subjects only), race, ethnicity, height (cm), weight (kg) and BMI (kg/m2) as well as baseline 
ECOG status and skin phototype will be summarized. The analysis will be based on the Safety 
population and ITT population. 
Descriptive statistics will be presented for age, height, weight, BMI. Frequency counts and 
percentage will be presented for sex, childbearing potential, race, ethnicity, ECOG status and 
skin phototype. 
The demographic and baseline characteristic data will also be presented as a data listing. 
5.4.3 
Medical History 
Medical history will be summarized by MedDRA system organ class and preferred term for the 
safety population. 


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Medical history details as collected on the CRF such as condition, MedDRA system organ class 
and preferred term, the date of onset, stop date and intensity of the condition will be presented 
in a by-subject data listing. 
5.4.4 
Primary Diagnosis and Oncology History 
Primary diagnosis and oncology history findings collected at the CRF, such as whether the 
subject has primary or metastatic tumor, tumor size and whether it is completely resectable, 
location of primary tumor (for subjects with metastatic tumor), biopsy of cytology results will 
be summarized descriptively and listed. 
5.4.5 
Protocol Deviations  
The study site will record all deviations occurred through the study on the CRF.  
Protocol deviation frequencies will be summarized descriptively by deviation type. 
All protocol deviations data collected on CRF will be presented as a by-subject data listing. 
5.4.6 
Photofrin® Injection 
All details of Photofrin® injections collected on CRF will be listed. 
5.4.7 
Photodynamic therapy 
All details of light application collected on CRF will be listed. 
5.4.8 
Surgery 
All details of the planned surgery collected on CRF will be summarized descriptively and 
listed. 
5.4.9 
Tumor and Healthy Tissue Response Analysis 
Macroscopic and microscopic examinations of the tumor and surrounding healthy lung tissue 
will be evaluated following the surgery. Findings collected on CRF will be summarized 
descriptively and listed. 
5.4.10 
ECOG Performance Status 
ECOG performance status will be assessed at Screening, prior to PDT procedure, prior to 
surgery, at the Day 20-25, Day 43-48 and Study Exit visits. Number and percentage of 
subjects with each status will be presented by visit. All results will be listed. 
5.4.11 
Safety Analysis 
All safety data will be listed and tabulated. The analysis will be performed on the Safety 
population. 
Safety parameters include adverse events, laboratory data, physical examination findings, vital 
signs and concomitant medications. 
5.4.11.1 Adverse Events 
Adverse Events will be coded using the Medical Dictionary of Regulatory Activities (MedDRA 
version 20.0) AE coding system for purpose of summarization. 


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Events collected at the “NCS Events” CRF page will be summarized together with Adverse 
Events, but excluded from analyses by CTCAE grade and relationship to study drug, since these 
data points are not captured for NCS events. 
An AE will be defined as treatment-emergent (TEAE) if its date of onset is on or after the date 
of the study drug (PHO) administration. 
An AE will be defined as treatment-related if its relationship to the study drug is recorded as 
“Reasonable Possibility” on the CRF. 
An overall summary of number and percentage of subjects with at least one AE, TEAE, serious 
TEAE, treatment-related TEAE, serious treatment-related TEAE, TEAE leading to 
discontinuation and fatal TEAE will be presented. 
A summary of the frequency (number and percentage of subjects) of TEAEs will be presented 
by system organ class and preferred term. One-sided 95% upper confidence limit will be 
computed for each AE percentage via exact (Clopper-Pearson) method for binomial proportion. 
Adverse events will also be analyzed by their CTCAE grade (1 to 5) and relationship to study 
drug (related or not related).  
A subject experiencing the same AE multiple times will be counted only once for that preferred 
term. Similarly, if a subject experiences multiple AEs (preferred terms) within the same system 
organ class, then that subject will be counted only once for that system organ class. When 
summarizing by CTCAE grade and relationship, only event with highest grade or relationship 
will be counted. All AEs will be presented in alphabetical order of SOC and preferred terms. 
Skin photosensitivity is an adverse event of special interest (AESI). Skin photosensitivity will 
be summarized separately by SOC and preferred term as well as by SOC, preferred term and 
CTCAE grade. 
All information pertaining to adverse events noted during the study will be listed by subject, 
detailing verbatim term given by the investigator, preferred term, system organ class, start date, 
stop date, CTCAE grade, outcome, action taken and drug relatedness. Separate listings will be 
created for Serious TEAEs, TEAEs leading to study drug discontinuation and skin 
photosensitivity events. 
5.4.11.2 Clinical Laboratory Parameters 
Samples will be obtained for the clinical laboratory tests at the following time points: Screening, 
Hospital Discharge (Day 5) and Study Exit visits. 
The following tests will be performed:  
• Chemistry: Glucose (random), Blood urea nitrogen, Sodium, Potassium, Chloride, 
Creatinine, 
Alkaline 
Phosphatase, 
Aspartate 
Aminotransferase, 
Alanine 
Aminotransferase, Total bilirubin, Albumin, Total protein. 
• Hematology: Hemoglobin, Hematocrit, White blood cell, Red blood cell, Platelet count, 
Prothrombin time  
Additionally, samples for Serum β-HCG pregnancy test will be collected from women of 
childbearing potential only at Screening, Day 43-48 visit and Study Exist visit. 


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Laboratory results for chemistry and hematology as well as changes from baseline will be 
summarized descriptively by visit. Only subjects with both non-missing baseline and time point 
values will be summarized at each time point. 
Shifts among normal, low and high results (as determined by laboratory normal ranges) from 
baseline to last available post-baseline assessment will be summarized. 
All individual subject clinical laboratory results will be presented in listings by subject and visit. 
Results of the pregnancy test will be listed. 
5.4.11.3 Physical Examination 
Comprehensive physical examination will be performed at Screening and Study Exit Visits. 
The physical examination will include assessment of the following systems: General 
Appearance, Skin, Head and Neck, Mouth, Lymph nodes, Thyroid, Abdomen, Musculoskeletal, 
Cardiovascular, Respiratory and Neurological. Each body system examined will be 
characterized as Normal or Abnormal. 
Physical examination findings will be summarized by visit. The number and percentage of 
subjects with normal and abnormal findings will be presented for each body system. 
Additionally, a shift table comparing the Screening and Study Exit evaluations will be created. 
All physical examination data will be provided in a listing. 
5.4.11.4 Vital Signs 
Vital signs (pulse, systolic and diastolic blood pressure, temperature, and respiration rate) will 
be collected at all visits. On Day 1, vital signs will be performed prior to Photofrin® injection 
and repeated at 15 and 30 minutes, 1, 2, 4, and 8 hours after injection. At other visits vital 
signs to be assessed once. 
Actual values of vital signs and changes from baseline will be summarized using descriptive 
statistics by time point. Only subjects with both non-missing baseline and time point values will 
be summarized at each time point.  
All vital signs data will be provided as a by-subject listing. 
5.4.11.5 Prior and Concomitant Medications 
Subjects may receive medication that is clinically indicated, such as pain prophylaxis, as per the 
investigator’s clinical judgement. The brand name (or, if unknown, the generic name), dose, 
dose unit (or dosage form if compound), frequency, route of administration, duration of use 
(start date and, if applicable, stop date) and indication for all previous medications and 
concomitant medications must be documented in the concomitant medication record section of 
the case report form (CRF). Concomitant medications include intravenous fluids, herbal 
products, vitamins, and any over-the-counter medicines. 
Prior medications are defined as those taken only before the date of informed consent, i.e. 
stopped before the date of informed consent. Concomitant medications are defined as any non-
study medication taken during the course of the study i.e. on or after the date of informed 


Concordia Laboratories Inc. 
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consent. Additionally, the medications will be considered concomitant if the stop date of the 
medication is missing (not available). 
Prior and concomitant medications will be summarized by anatomical-therapeutic-chemical 
(ATC) classification (highest level available) and WHO Drug Dictionary preferred term. 
Prior and concomitant medication information will be presented in a by-subject listing with 
ATC classification (highest level available) and WHO Drug Dictionary preferred term, start and 
stop date, dosage, route, frequency and indication. 
5.4.11.6 Adjunctive Therapy/Procedures 
An adjunctive therapy/procedure is defined as any procedure or intervention (e.g., 
psychotherapy, surgery, dental work, acupuncture, physiotherapy, chiropracty, osteopathy) 
used to treat an illness.  
The adjunctive therapy/procedure (type, duration of use [start date and, if applicable, stop 
date], and indication) received during 30 days prior to the date of the ICF signature and 
throughout the study will be recorded in the adjunctive therapy record of the CRF. 
Frequency of adjunctive therapies will be summarized descriptively by therapy type. All 
information will be listed. 
5.4.12 
Chest X-ray 
Chest X-ray will be performed at Screening, if not done up to 90 days prior to the visit, as well 
as at the Hospital Discharge and Day 20-25 visits. X-ray will be classified as normal or 
abnormal. Number and percentage of subjects with normal and abnormal findings will be 
presented by visit. All findings will be listed. 
5.4.13 
Other Assessments 
12-lead ECG will be performed at screening if not done up to 30 days prior to the informed 
consent. Results will be listed. 
Light challenge will be performed by subjects at home prior to Day 43-48 visit. Results will 
be listed. 
Information on unanticipated events (physical risk, psychological risk, economic risk, social 
risk, other) will be collected throughout the study.  Results will be listed. 
CT scan will be performed prior to surgery and at the Day 43-48 and Study Exit visits. 
Findings will be listed. 
6. 
CHANGES IN ANALYSIS FROM PROTOCOL 
There are no changes from the protocol-specified analyses. 


Concordia Laboratories Inc. 
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Date Apr 10, 2018 
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7. 
REFERENCES 
1. Study protocol: "A Multicenter, Prospective, Open-Label, Non-Randomized Single-Arm 
Clinical Study of the Safety and Tissue Response to Photodynamic Therapy Using Porfimer 
Sodium for Injection as Treatment for Solid Lung Tumor Prior to Surgical Resection", 
version 1 dated Mar 1, 2017. 
 


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8. 
APPENDICES 
Table 1 
Study Schedule  
Procedures/Examinations 
STUDY TIME 
S 
E 
Period I - PDT Course 
Period II- 
Surgery 
Period III - Follow-up 
Days 
-30 to -1 
Day 
0 
Injection 
Day 1 
PDT Day 3 
40-50 H 
Hospital 
Dischargeg 
Day 5 
Day 13-18 
Day 20-25 
(±2 days) 
Day 43-48 
(±3 days) 
Study Exit 
Day 103-108 
(±7 days) 
Informed Consent  
X 
 
 
 
 
 
 
 
 
Eligibility criteria  
Xa  
 
X 
 
 
 
 
 
 
Demography  
X 
 
 
 
 
 
 
 
 
Medical and oncologic history and 
current medical conditions  
X 
 
 
 
 
 
 
 
 
Skin phototype  
X 
 
 
 
 
 
 
 
 
Vital signsb  
X  
 
X 
X 
X 
X 
X 
X 
X 
Height  
X 
 
 
 
 
 
 
 
 
Body weight  
X  
 
X 
 
 
 
 
 
 
Comprehensive physical examination 
X  
 
 
 
 
 
 
 
X 
ECOG Status  
X  
 
 
X 
 
X 
X 
X 
X 
Chest X-ray  
Xc  
 
 
 
X 
 
X 
 
 
12-lead ECG  
Xd 
 
 
 
 
 
 
 
 
CT scan and evaluation  
 
 
 
 
 
X 
 
X 
X 
Clinical labse  
X  
 
 
 
X 
 
 
 
X 
Serum -HCGf  
X  
 
 
 
 
 
 
X 
X 
Enrolment  
 
X 
 
 
 
 
 
 
 
Photofrin® injection  
 
 
X 
 
 
 
 
 
 
Instructions to subjects  
  
X 
X 
X 
X 
X 
X 
X 
X 
PDT & 48-hour hospitalization  
 
 
 
X 
 
 
 
 
 
Macro/microscopic tissue examination 
 
 
 
 
 
X 
 
 
 
Light Challenge  
 
 
 
 
 
 
 
X 
 
Record Adverse Eventsh  
X  
 
X 
X 
X 
X 
X 
X 
X 
Medication/Therapy Assessmenti  
X  
 
X 
X 
X 
X 
X 
X 
X 
S=Screening; E=Enrolment; a Will include radiology/pathology reports confirming primary or metastatic solid tumor in peripheral lung and thoracic surgeon confirming the tumor resectability; b On 
Day 1, vital signs (pulse, blood pressure, temperature, and respiration rate) to be performed prior to Photofrin® injection and repeated at 15 and 30 minutes, 1, 2, 4, and 8 hours after injection. 
Afterwards, vital signs to be assessed once, prior to all other procedures being performed; c If not done up to 90 days prior to ICF signature; d If not done up to 30 days prior to ICF signature; e Clinical 
labs to include hematology and chemistry as specified in Appendix 13-4; f For females of childbearing potential only, who must agree to use acceptable contraceptive method for 90 days post 
Photofrin® injection; g Subject to be discharged from the 48-hour hospital stay after the Chest X-ray and other safety evaluations indicating that the subject is stable and able to be discharged; otherwise, 
the subject’s hospital stay may be extended to 72 hours or until the subject is stable for discharge; h All AEs to be recorded from the time of ICF signature; i All medications and adjunctive 
therapies/procedures to be recorded 30 days prior to screening and throughout the study.