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

Amgen

Status and phase: Completed; Phase 2; Phase 1

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: AMG 655; Other: AMG 655 placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00534027

20060295

Details and patient eligibility

About

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).

Enrollment: 172 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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172 participants in 3 patient groups, including a placebo group

Arm 2

Experimental group

Description:

Low Dose AMG 655 with paclitaxel/carboplatin

Treatment:

Drug: AMG 655

Arm 3

Placebo Comparator group

Description:

Placebo with paclitaxel/carboplatin

Treatment:

Other: AMG 655 placebo

Arm 1

Experimental group

Description:

AMG 655 High doseplus paclitaxel/carboplatin

Treatment:

Drug: AMG 655