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

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).

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AMG 655

Drug

AMG 655 is a monoclonal antibody directed against TR-2.

Other names: Placebo

AMG 655 placebo

Other

Inactive dummy AMG 655 (to maintain blind)

Primary outcomes

Progression free survival

Time frame: Until disease progression

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Important dates

Study start: 2008
Primary completion: 2011
Study completion: 2011
First posted: Sep 24, 2007
Registry last updated: Jan 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed