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

NCT00534027 | Completed Phase 1

• 1 other identifier: 20060295
• Study Type: interventional
• Target: 172
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Non-Small Cell Lung Cancer

Keywords

NSCLC; Non-Small Cell Lung Cancer; Paclitaxel; Carboplatin; AMG 655

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  Until disease progression

Secondary Outcomes (1)

• Objective response rate, duration of response, time to response, overall survival and incidence of adverse events and clinical laboratory abnormalities

  Until disease progression

Study Arms (3)

Arm 2

EXPERIMENTAL

Low Dose AMG 655 with paclitaxel/carboplatin

Drug: AMG 655

Arm 3

PLACEBO COMPARATOR

Placebo with paclitaxel/carboplatin

Other: AMG 655 placebo

Arm 1

EXPERIMENTAL

AMG 655 High doseplus paclitaxel/carboplatin

Drug: AMG 655

Interventions

AMG 655 DRUG

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

Also known as: Placebo

Arm 1; Arm 2

AMG 655 placebo OTHER

Inactive dummy AMG 655 (to maintain blind)

Arm 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Related Publications (1)

• 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.

  PMID: 23370314 DERIVED

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

conatumumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2007
• First Posted: September 24, 2007
• Study Start: January 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: January 14, 2016

Record last verified: 2015-12