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

Amgen

Status and phase: Completed; Phase 2; Phase 1

Conditions: Non Small Cell Lung Cancer

Treatments: Drug: Carboplatin; Drug: AMG 386 Placebo; Drug: AMG 386; Drug: Pemetrexed

Study type: Interventional

Funder types: Industry

Identifiers

NCT01666977

2011-001111-31 (EudraCT Number)

20101128

Details and patient eligibility

About

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

Full 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

Enrollment: 36 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

36 participants in 3 patient groups

Arm A

Experimental group

Description:

Arm A: AMG 386 placebo IV QW, pemetrexed 500 mg/m2 IV Q3W, carboplatin AUC 6 IV Q3W, for up to 6 cycles

Treatment:

Drug: Pemetrexed

Drug: Carboplatin

Drug: AMG 386 Placebo

Arm B

Experimental group

Description:

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

Treatment:

Drug: AMG 386

Drug: Pemetrexed

Drug: AMG 386

Drug: Carboplatin

Arm C

Experimental group

Description:

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

Treatment:

Drug: AMG 386

Drug: Pemetrexed

Drug: AMG 386

Drug: Carboplatin