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

A Phase 1b/2 Trial of AMG 386 in Combination With Pemetrexed and Carboplatin as First Line Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01666977

Enrollment

Registered

2012-08-17

Start date

2012-08-31

Completion date

2015-11-30

Last updated

2016-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung Cancer

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

Interventions

DRUGAMG 386

15mg/kg

DRUGAMG 386 Placebo

AMG 386 Placebo

DRUGPemetrexed

Pemetrexed 500 mg/m2

DRUGCarboplatin

Carboplatin AUC 6

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 95 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Australia, Belgium, Canada, Greece, Spain, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026