Phase 1b/2 Trial of AMG386 With Pemetrexed and Carboplatin in Non-Small Cell Lung Cancer

Phase 1

Completed

• Conditions: Non Small Cell Lung Cancer
• Interventions: Drug: AMG 386 Placebo; Drug: AMG 386; Drug: Pemetrexed; Drug: Carboplatin

• Registration Number: NCT01666977
• Lead Sponsor: Amgen

Brief Summary

The purpose of this phase 1b/2 study is to estimate the treatment effect of study drug measuring progression free survival.

Detailed Description

To evaluate the incidence of adverse events and clinical laboratory abnormalities defined as dose-limiting toxicity in subjects with metastatic non-squamous non-small cell lung cancer (NSCLC) treated with AMG 386 in combination with pemetrexed and carboplatin

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-15
• Study First Submitted QC: 2012-08-15
• Study First Posted: 2012-08-17
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Disposition First Submitted: 2016-03-10
• Disposition First Submitted QC: 2016-04-15
• Status Verified: 2016-05
• Disposition First Posted: 2016-05-16
• Last Update Submitted: 2016-05-18
• Last Update Posted: 2016-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Histologically confirmed, unresectable stage IV non-squamous non small cell lung cancer (NSCLC)
• Radiographically evaluable disease (measurable or non-measurable) per RECIST 1.1 with modifications
• Adequate hematological, renal, and hepatic function, normal coagulation profile, calculated CrCL ≥ 45 mL/min
• Other criteria may apply

Exclusion Criteria

• Any prior chemotherapy or targeted therapy for non-squamous NSCLC
• Subjects with adenosquamous histology or any histology subtype containing greater than 10% squamous cells
• Subjects with an epidermal growth factor receptor (EGFR) mutation sensitive to treatment with a tyrosine kinase inhibitor (TKI)
• Subjects with known anaplastic lymphoma kinase (EML4-ALK) translocations
• History or presence of central nervous system metastases
• Central (chest) radiation therapy within 28 days prior to enrollment/randomization, radiation therapy to any other site(s) within 14 days prior to enrollment/randomization
• History of pulmonary hemorrhage or gross hemoptysis within 6 months
• History of arterial or venous thromboembolism within 12 months
• History of clinically significant bleeding within 6 months
• Clinically significant cardiovascular disease within 12 months
• Other criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	AMG 386 Placebo	Arm A: AMG 386 placebo IV QW, pemetrexed 500 mg/m2 IV Q3W, carboplatin AUC 6 IV Q3W, for up to 6 cycles
Arm B	AMG 386	Arm B: AMG 386 15 mg/kg IV QW, pemetrexed 500 mg/m2 IV Q3W, carboplatin AUC 6 IV Q3W, for up to 6 cycles
Arm C	AMG 386	Arm C: AMG 386 30 mg/kg IV QW, pemetrexed 500 mg/m2 IV Q3W, carboplatin AUC 6 IV Q3W, for up to 6 cycles
Arm C	Pemetrexed	Arm C: AMG 386 30 mg/kg IV QW, pemetrexed 500 mg/m2 IV Q3W, carboplatin AUC 6 IV Q3W, for up to 6 cycles
Arm A	Carboplatin	Arm A: AMG 386 placebo IV QW, pemetrexed 500 mg/m2 IV Q3W, carboplatin AUC 6 IV Q3W, for up to 6 cycles
Arm A	Pemetrexed	Arm A: AMG 386 placebo IV QW, pemetrexed 500 mg/m2 IV Q3W, carboplatin AUC 6 IV Q3W, for up to 6 cycles
Arm B	Pemetrexed	Arm B: AMG 386 15 mg/kg IV QW, pemetrexed 500 mg/m2 IV Q3W, carboplatin AUC 6 IV Q3W, for up to 6 cycles
Arm B	Carboplatin	Arm B: AMG 386 15 mg/kg IV QW, pemetrexed 500 mg/m2 IV Q3W, carboplatin AUC 6 IV Q3W, for up to 6 cycles
Arm C	Carboplatin	Arm C: AMG 386 30 mg/kg IV QW, pemetrexed 500 mg/m2 IV Q3W, carboplatin AUC 6 IV Q3W, for up to 6 cycles

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	Incidence of adverse events and clinical laboratory abnormalities defined as a DLT	Subjects will be evaluated for progression free survival.

Trial Locations

Locations (1)

Research Site; 🇪🇸 Madrid, Spain