A Phase 2 Trial of AMG 706 or Bevacizumab in Combination With Chemo for Advanced NSCLC

Amgen

Status and phase: Terminated; Phase 2

Conditions: Advanced Non-squamous NSCLC

Treatments: Drug: Carboplatin; Drug: AMG 706; Biological: Bevacizumab; Drug: Paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00369070

20060136

Details and patient eligibility

About

The purpose of this study is to estimate the difference in objective response rates between each paclitaxel/carboplatin plus AMG 706 arm (Arm A and B) and paclitaxel/carboplatin plus bevacizumab arm (Arm C) in subjects with advanced non-squamous NSCLC.

Enrollment: 186 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men or women 18 years or older with histologically or cytologically confirmed advanced non-squamous NSCLC (unresectable stage IIIB with pericardial or pleural effusion or stage IV/recurrent)
• Measureable disease per RECIST criteria modified
• ECOG performance status of 0 or 1
• Ability to take oral medications
• Competent to give written informed consent

Exclusion criteria

• Current or prior history of CNS metastases
• Any prior chemotherapy for advanced NSCLC
• History of pulmonary hemorrhage or gross hemoptysis within 6 months prior to randomization
• Prior targeted therapies
• Known history of allergy or hypersensitivity to paclitaxel or carboplatin
• History of arterial or venous thrombosis within 52 weeks prior to randomization
• History of bleeding diathesis or non-pulmonary bleeding within 14 days prior to randomization
• Peripheral neuropathy > grade 1 per CTCAE Version 3.0
• Myocardial infarction, cerebrovascular accident, grade 2 or greater peripheral vascular disease, transient ischemic attack, congestive heart failure, percutaneous transluminal coronary angioplasty/stent, ongoing arrythmias requiring medication or unstable angina within 52 weeks prior to randomization
• Any kind of disorder that compromises the ability of the subject to comply with the study procedures
• Uncontrolled hypertension as defined by resting blood pressure > 150/90 mm Hg. Anti-hypertensive medications are allowed if hypertension is stably controlled at the time of randomization.
• Participation in therapeutic clinical trials or currently receiving other investigational treatment(s) within 30 days prior to randomization
• Pregnant or breast feeding women
• Known to be HIV, hepatitis B surface antigen, or hepatitis C positive

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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186 participants in 3 patient groups

A

Experimental group

Description:

AMG 706 125 mg once daily (QD) and paclitaxel and carboplatin chemotherapy regimen (paclitaxel 200 mg/m2 and carboplatin at AUC of 6 mg/mL x min) on day 1 of each 3 week cycle for a maximum of 6 cycles.

Treatment:

Drug: Carboplatin

Drug: AMG 706

Drug: Paclitaxel

B

Experimental group

Description:

AMG 706 75 mg twice daily every 12 ± approximately 1 hour for 5 days followed by a 2 day treatment free period every 7 days and paclitaxel and carboplatin chemotherapy regimen (paclitaxel 200 mg/m2 and carboplatin at AUC of 6 mg/mL x min) on day 1 of each 3 week cycle for a maximum of 6 cycles.

Treatment:

Drug: Carboplatin

Drug: AMG 706

Drug: Paclitaxel

C

Active Comparator group

Description:

Bevacizumab 15 mg/kg bevacizumab, delivered via intravenous (IV) infusion once every 3 weeks and paclitaxel and carboplatin chemotherapy regimen (paclitaxel 200 mg/m2 and carboplatin at AUC of 6 mg/mL x min) on day 1 of each 3 week cycle for a maximum of 6 cycles.

Treatment:

Drug: Carboplatin

Biological: Bevacizumab

Drug: Paclitaxel