Clinical trial

A Phase III, Open Label, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Compared With a Platinum Agent (Cisplatin or Carboplatin) in Combination With Either Pemetrexed or Gemcitabine for PD-L1-Selected, Chemotherapy-Naive Patients With Stage IV Non-Squamous Or Squamous Non-Small Cell Lung Cancer

Name

GO29431

Description

This randomized, open-label study will evaluate the efficacy and safety of atezolizumab compared with chemotherapy consisting of a platinum agent (cisplatin or carboplatin per investigator discretion) combined with either pemetrexed (non-squamous disease) or gemcitabine (squamous disease) in programmed death-ligand 1 (PD-L1)-selected, chemotherapy-naive participants with Stage IV Non-Squamous or Squamous NSCLC.

Trial arms

Trial start

2015-07-20

Estimated PCD

2020-02-04

Trial end

2022-03-08

Status

Completed

Phase

Early phase I

Treatment

Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody

Atezolizumab 1200 milligram (mg) will be administered as intravenous infusion every 21 days until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).

Arms:

Atezolizumab

Other names:

MPDL3280A, RO5541267

Carboplatin

Carboplatin will be administered as intravenous infusion at a dose of area under the concentration-time curve (AUC) 6 when given in combination with pemetrexed or at a dose of AUC 5 when given in combination with gemcitabine, every 21 days for 4 or 6 cycles as per local standard of care.

Arms:

(Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)

Cisplatin

Cisplatin will be administered as intravenous infusion at a dose of 75 mg per meter squared (mg/m\^2) every 21 days for 4 or 6 cycles as per local standard of care.

Arms:

(Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)

Gemcitabine

Gemcitabine will be administered as intravenous infusion at a dose of 1250 mg/m\^2 (in combination with cisplatin) or 1000 mg/m\^2 (in combination with carboplatin), on Days 1 and 8 of each 21-day cycle for 4 or 6 cycles as per local standard of care.

Arms:

(Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)

Pemetrexed

Pemetrexed will be administered as intravenous infusion at a dose of 500 mg/m\^2 on Day 1 of each 21-day cycle as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months).

Arms:

(Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)

Size

572

Primary endpoint

Overall Survival (OS) in the TC3 or IC3-WT Populations

From randomization to death from any cause until data cut-off on 10 September 2018 (up to approximately 38 months)

Overall Survival (OS) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations

From randomization to death from any cause until data cut-off on 4 February 2020 (up to approximately 54.5 months)

Eligibility criteria

Inclusion Criteria: * Histologically or cytologically confirmed, Stage IV non-squamous or squamous NSCLC * No prior treatment for Stage IV non-squamous or squamous NSCLC. Participant known to have a sensitizing mutation in the epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) fusion oncogene are excluded from the study * Tumor PD-L1 expression as determined by immunohistochemistry (IHC) assay of archival tumor tissue or tissue obtained at screening * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 * Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) * Adequate hematologic and end-organ function Exclusion Criteria: * Known sensitizing mutation in the EGFR gene or ALK fusion oncogene * Active or untreated central nervous system (CNS) metastases as determined by Computed Tomography (CT) or magnetic resonance imaging (MRI) evaluation * 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 * 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 CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted * Positive test for Human Immunodeficiency Virus (HIV) * Active hepatitis B or hepatitis C * Prior treatment with cluster of differentiation (CD) 137 agonists or immune checkpoint blockade therapies, anti PD1, and anti-PD-L1 therapeutic antibody * Severe infection within 4 weeks prior to randomization * Significant history of cardiovascular disease

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 572, 'type': 'ACTUAL'}}

Updated at

2023-03-15

1 organization

5 products

2 indications

Organization

Hoffmann La Roche

Product

Carboplatin

Indication

Non-Squamous Non-Small Cell Lung Cancer

Indication