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

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Conatumumab; Paclitaxel

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