Back to resultsA Phase 1b/2 Study of AMG 655 in Combination With Paclitaxel and Carboplatin for the First-Line Treatment of Advanced Non-Small Cell Lung Cancer
Primary Purpose
Non-Small Cell Lung Cancer
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
AMG 655
AMG 655 placebo
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring NSCLC, Non-Small Cell Lung Cancer, Paclitaxel, Carboplatin, AMG 655
Eligibility Criteria
Inclusion Criteria:
Disease Related
- Histologically or cytologically confirmed non-small cell lung cancer.
- Subjects must have advanced non-small cell lung cancer defined as stage IIIB with malignant pleural effusion or stage IV or recurrent disease.
- Planning to receive up to 6 cycles of chemotherapy
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 Demographic
- Men or women > 18 years of age Ethical
- Adequate Hematological, renal, hepatic and coagulation function General
- Plan to begin protocol specific therapy < 7 days after enrollment/randomization
Exclusion Criteria:
Disease Related
- Untreated or symptomatic central nervous system metastases. Subjects with a history of brain metastases are eligible if definitive therapy has been administered (surgery and/or radiation therapy), there is no planned treatment for brain metastasis and the subject is clinically stable and off corticosteroids for at least 14 days before enrollment/randomization.
- Prior chemotherapy as follows:
- Any prior chemotherapy for advanced non-small cell lung cancer
- Any prior adjuvant chemotherapy for non-small cell lung cancer < 52 weeks prior to enrollment/randomization. Adjuvant chemotherapy completed > 52 weeks prior to randomization is permitted.
- Any prior chemoradiation.
- Central (chest) radiation therapy < 28 days prior to randomization, radiation therapy for peripheral lesions < 14 days prior to enrollment/randomization
- Other abnormal medical conditions
- Documented myocardial infarction or unstable/uncontrolled cardiac condition
- History of arterial thrombosis, pulmonary embolus, deep vein thrombosis or hemorrhagic disorders
- Major surgical procedure < 30 days prior to enrollment/randomization or not yet recovered from prior major surgery, Minor surgical procedure < 7 days prior to enrollment/randomization or not yet recovered from prior minor surgery
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Experimental
Arm Label
Arm 2
Arm 3
Arm 1
Arm Description
Low Dose AMG 655 with paclitaxel/carboplatin
Placebo with paclitaxel/carboplatin
AMG 655 High doseplus paclitaxel/carboplatin
Outcomes
Primary Outcome Measures
Progression free survival
Secondary Outcome Measures
Objective response rate, duration of response, time to response, overall survival and incidence of adverse events and clinical laboratory abnormalities
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00534027
Brief Title
A Phase 1b/2 Study of AMG 655 in Combination With Paclitaxel and Carboplatin for the First-Line Treatment of Advanced Non-Small Cell Lung Cancer
Official Title
A Phase 1b/2 Study of AMG 655 in Combination With Paclitaxel and Carboplatin for the First-Line Treatment of Advanced Non-Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
5. Study Description
Brief Summary
Part 1 is complete. Part 2 is a multi-center, randomized, double-blind, placebo-controlled, phase 2 segment that will commence upon identification of the maximum tolerated dose in part 1. The Primary objective of Part 2 of the study is to estimate efficacy in combination with carboplatin and paclitaxel. Subjects will be randomized at a 1:1:1 ratio to 1 of 3 treatment arms. Subjects in each of the 3 arms will receive up to 6 cycles of paclitaxel/carboplatin (at the same dose and schedule in part 1) in combination with either AMG 655 at the maximum tolerated dose (Arm 1), AMG 655 at a lower dose (Arm 2), or AMG 655 placebo (Arm 3) IV Q3W. Randomization will be stratified by ECOG (0 or 1) and disease stage (IIIb or IV/recurrent).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
NSCLC, Non-Small Cell Lung Cancer, Paclitaxel, Carboplatin, AMG 655
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
172 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
Low Dose AMG 655 with paclitaxel/carboplatin
Arm Title
Arm 3
Arm Type
Placebo Comparator
Arm Description
Placebo with paclitaxel/carboplatin
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
AMG 655 High doseplus paclitaxel/carboplatin
Intervention Type
Drug
Intervention Name(s)
AMG 655
Other Intervention Name(s)
Placebo
Intervention Description
AMG 655 is a monoclonal antibody directed against TR-2.
Intervention Type
Other
Intervention Name(s)
AMG 655 placebo
Intervention Description
Inactive dummy AMG 655 (to maintain blind)
Primary Outcome Measure Information:
Title
Progression free survival
Time Frame
Until disease progression
Secondary Outcome Measure Information:
Title
Objective response rate, duration of response, time to response, overall survival and incidence of adverse events and clinical laboratory abnormalities
Time Frame
Until disease progression
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Disease Related
Histologically or cytologically confirmed non-small cell lung cancer.
Subjects must have advanced non-small cell lung cancer defined as stage IIIB with malignant pleural effusion or stage IV or recurrent disease.
Planning to receive up to 6 cycles of chemotherapy
Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 Demographic
Men or women > 18 years of age Ethical
Adequate Hematological, renal, hepatic and coagulation function General
Plan to begin protocol specific therapy < 7 days after enrollment/randomization
Exclusion Criteria:
Disease Related
Untreated or symptomatic central nervous system metastases. Subjects with a history of brain metastases are eligible if definitive therapy has been administered (surgery and/or radiation therapy), there is no planned treatment for brain metastasis and the subject is clinically stable and off corticosteroids for at least 14 days before enrollment/randomization.
Prior chemotherapy as follows:
Any prior chemotherapy for advanced non-small cell lung cancer
Any prior adjuvant chemotherapy for non-small cell lung cancer < 52 weeks prior to enrollment/randomization. Adjuvant chemotherapy completed > 52 weeks prior to randomization is permitted.
Any prior chemoradiation.
Central (chest) radiation therapy < 28 days prior to randomization, radiation therapy for peripheral lesions < 14 days prior to enrollment/randomization
Other abnormal medical conditions
Documented myocardial infarction or unstable/uncontrolled cardiac condition
History of arterial thrombosis, pulmonary embolus, deep vein thrombosis or hemorrhagic disorders
Major surgical procedure < 30 days prior to enrollment/randomization or not yet recovered from prior major surgery, Minor surgical procedure < 7 days prior to enrollment/randomization or not yet recovered from prior minor surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
23370314
Citation
Paz-Ares L, Balint B, de Boer RH, van Meerbeeck JP, Wierzbicki R, De Souza P, Galimi F, Haddad V, Sabin T, Hei YJ, Pan Y, Cottrell S, Hsu CP, RamLau R. A randomized phase 2 study of paclitaxel and carboplatin with or without conatumumab for first-line treatment of advanced non-small-cell lung cancer. J Thorac Oncol. 2013 Mar;8(3):329-37. doi: 10.1097/JTO.0b013e31827ce554.
Results Reference
derived
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
A Phase 1b/2 Study of AMG 655 in Combination With Paclitaxel and Carboplatin for the First-Line Treatment of Advanced Non-Small Cell Lung Cancer
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