Clinical trial NCT01107444: Study of LY2181308 in Combination With Docetaxel Versus Docetaxel in Patients With Non-Small Cell Lung Cancer
Official title: A Randomized Phase 2 Study of LY2181308 in Combination With Docetaxel Versus Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Were Previously Treated With First Line Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2010-04-21
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the anti-tumor activity of LY2181308 in combination with docetaxel compared to docetaxel alone in participants with non-small cell lung cancer who were previously treated with first line chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Participants with non-small cell lung cancer with locally or advanced metastatic disease(Stage IIIB or IV at entry) not amenable to curative therapy and who have progressed after 1 line of chemotherapy
* Measureable disease as defined by response evaluation criteria in solid tumors (RECIST) version 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
* Must make available any existing tumor tissue from the primary biopsy
* Participants with prior radiation may be eligible if they meet certain criteria
* Adequate bone marrow reserve and organ functioning
* Women must have a negative pregnancy test and must comply with a highly reliable contraceptive method during and for 6 months after the treatment period and must not be breastfeeding
* Men must comply with a contraceptive regimen during and for 6 months after the treatment period

Exclusion Criteria:

* Currently enrolled in or discontinued a clinical trial involving an investigational drug/device within the last 30 days. Participants may be permitted to enter treatment before the 30 day waiting period in special circumstances
* Pregnant or breastfeeding
* Serious concomitant systemic disorders that would compromise the safety of the participant or the participant's ability to complete the study
* Second primary malignancy that could affect compliance with the protocol or interpretation of the study results
* Known allergy or hypersensitivity to docetaxel, taxanes, LY2181308, oligonucleotides, or any component of the formulations
* Participants with documented central nervous system or brain metastasis at the time of study entry
* Pre-existing neuropathy equivalent to a common terminology criteria for adverse events(CTCAE)code greater than or equal to 2

Primary outcomes:
measure: Change From Baseline in Tumor Size to the End of Cycle 2
timeFrame: Baseline, End of Cycle 2 (1 cycle = 21 days)
Secondary outcomes:
measure: Number of Participants With Characterization of Toxicities as Defined by Common Terminology Criteria for Adverse Events (CTCAE) Coding
timeFrame: Randomization through long-term follow up (up to 21.6 months)
measure: Progression Free Survival (PFS)
timeFrame: Randomization to the first date of progressive disease or death from any cause (up to 12.88 months)
measure: Pharmacokinetics: Area Under the Concentration Curve From Zero to 4 Hours (AUC[0-4]) for LY2181309 and Docetaxel
timeFrame: Docetaxel: Cycle(C)1 Day(D)1:0,1,1.25,1.75,3,4 hours(h);LY2181308 + Docetaxel: C1 D-1:3,4 h;D1:0,3,4 h
measure: Pharmacokinetics: Area Under the Drug Concentration-Time Curve From Zero to Infinity (AUC[0 ∞]) of LY2181309 and Docetaxel
timeFrame: Docetaxel: Cycle(C)1 Day(D)1:0,1,1.25,1.75,3,4,5,505,513,2521 hours(h);LY2181308 + Docetaxel: C1 D -1:3,4 h;D1:0,3,4,5,5.25,5.75,7,8,120,504,507,509,1008,1512,1515,1517,2016, 2520,2523,2525 h
measure: Overall Survival (OS)
timeFrame: Randomization to date of death from any cause (up to 21.6 months)
measure: Time to Worsening of Symptoms as Defined by Lung Cancer Symptom Score (LCSS) Questionnaire
timeFrame: Baseline to the worsening of symptoms (up to 4.6 months)
measure: Time to Objective Tumor Response of Partial Response (PR) or Complete Response (CR)
timeFrame: Randomization to the date of first response (up to 12.1 months)
measure: Time to Documented Disease Progression
timeFrame: Randomization to the first date of progressive disease (up to 12.9 months)
measure: Percent of Participants Having a Partial Response (PR) or a Complete Response (CR)
timeFrame: Randomization to the first date of progressive disease (up to 12.1 months)
measure: Duration of Response
timeFrame: Time of response to progressive disease (PD) (approximately 8.7 months)
measure: Lung Cancer Symptom Scale (LCSS) Average Symptom Burden Index (ASBI) on Cycle 2 Day 1
timeFrame: Cycle 2 Day 1
measure: Lung Cancer Symptom Scale (LCSS) Average Total Score at Cycle 2 Day 1
timeFrame: Cycle 2 Day 1
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: California
city: Tampa
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Florida
city: Chicago
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Illinois
city: Detroit
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Michigan
city: Minneapolis
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Minnesota
city: Lebanon
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: New Hampshire
city: New York
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: New York
city: Charleston
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: South Carolina
city: Madison
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Wisconsin
city: Brussels
country: Belgium
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Edegem
country: Belgium
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Leuven
country: Belgium
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Braunschweig
country: Germany
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Hamburg
country: Germany
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Hannover
country: Germany
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Heidelberg
country: Germany
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Karlsruhe
country: Germany
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Mannheim
country: Germany
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Muenster
country: Germany
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Ulm
country: Germany
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Aviano
country: Italy
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Genova
country: Italy
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Lido Di Camaiore
country: Italy
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Orbassano
country: Italy
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Pisa
country: Italy
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Rome
country: Italy
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Gdansk
country: Poland
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Poznan
country: Poland
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Szczecin-Zdunowo
country: Poland
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Warsaw
country: Poland
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: London
country: United Kingdom
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: England
city: Nottingham
country: United Kingdom
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Nottinghamshire
city: Headington
country: United Kingdom
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Oxford
city: Aberdeen
country: United Kingdom
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Scotland
city: Sheffield
country: United Kingdom
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Trent
city: Manchester
country: United Kingdom
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT- 5 hours, EST)
role: STUDY_DIRECTOR
References:
citation: Natale R, Blackhall F, Kowalski D, Ramlau R, Bepler G, Grossi F, Lerchenmuller C, Pinder-Schenck M, Mezger J, Danson S, Gadgeel SM, Summers Y, Callies S, Andre V, Das M, Lahn M, Talbot D. Evaluation of antitumor activity using change in tumor size of the survivin antisense oligonucleotide LY2181308 in combination with docetaxel for second-line treatment of patients with non-small-cell lung cancer: a randomized open-label phase II study. J Thorac Oncol. 2014 Nov;9(11):1704-8. doi: 10.1097/JTO.0000000000000285.