A Study of Atezolizumab in Combination With Carboplatin Plus (+) Nab-Paclitaxel Compared With Carboplatin+Nab-Paclitaxel in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (IMpower130)

Roche

Status and phase: Completed; Phase 3

Conditions: Carcinoma, Non-Squamous Non-Small Cell Lung

Treatments: Drug: Pemetrexed; Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody; Drug: Carboplatin; Drug: Nab-Paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02367781

2014-003206-32 (EudraCT Number)

GO29537

Details and patient eligibility

About

This randomized Phase III, multicenter, open-label study designed to evaluate the safety and efficacy of atezolizumab (an engineered anti-programmed death-ligand 1 [PD-L1] antibody) in combination with carboplatin+nab-paclitaxel compared with treatment with carboplatin+nab-paclitaxel in chemotherapy-naive participants with Stage IV non-squamous NSCLC. Participants were randomized in a 2:1 ratio to Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) or Arm B (Nab-Paclitaxel+Carboplatin).

Enrollment: 723 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Eastern Cooperative Oncology Group performance status of 0 or 1
• Histologically or cytologically confirmed, Stage IV non-squamous NSCLC
• Participants with no prior treatment for Stage IV non-squamous NSCLC
• Previously obtained archival tumor tissue or tissue obtained from fresh biopsy at screening
• Measurable disease, as defined by RECIST v1.1
• Adequate hematologic and end organ function

Exclusion criteria

Cancer-Specific Exclusions:

• Active or untreated central nervous system metastases
• Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome

General Medical Exclusions:

• Pregnant or lactating women
• History of autoimmune disease
• History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
• Positive test for human immunodeficiency virus
• Active hepatitis B or hepatitis C
• Severe infection within 4 weeks prior to randomization
• Significant cardiovascular disease
• Illness or condition that interferes with the participant's capacity to understand, follow and/or comply with study procedures

Exclusion Criteria Related to Medications:

• Prior treatment with cluster of differentiation 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1, and anti-PD-L1 therapeutic antibodies

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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723 participants in 2 patient groups

Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)

Experimental group

Description:

Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurred first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.

Treatment:

Drug: Nab-Paclitaxel

Drug: Carboplatin

Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody

Arm B (Nab-Paclitaxel+Carboplatin)

Active Comparator group

Description:

Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurred first during induction treatment phase. Participants received best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed was also permitted. Participants who were consented prior to approval of protocol Version 5 were given the option to cross over to receive atezolizumab as monotherapy until disease progression.

Treatment:

Drug: Nab-Paclitaxel

Drug: Carboplatin

Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody

Drug: Pemetrexed