Clinical trial NCT00534027: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Non-Small Cell Lung Cancer
Keywords: NSCLC
Non-Small Cell Lung Cancer
Paclitaxel
Carboplatin
AMG 655
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2007-09-24
Enrollment: 172
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: 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).


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

Primary outcomes:
measure: Progression free survival
timeFrame: Until disease progression
Secondary outcomes:
measure: Objective response rate, duration of response, time to response, overall survival and incidence of adverse events and clinical laboratory abnormalities
timeFrame: Until disease progression
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
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.