A Study of Atezolizumab Compared With Gemcitabine Plus (+) Cisplatin or Carboplatin for PD-L1-Selected Participants With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) (IMpower111)

Roche

Status and phase: Terminated; Phase 3

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: Gemcitabine; Drug: Cisplatin; Drug: Atezolizumab; Drug: Carboplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02409355

2014-003106-33 (EudraCT Number)

GO29432

Details and patient eligibility

About

This randomized, open-label study was designed to evaluate and compare the safety and efficacy of atezolizumab with gemcitabine + cisplatin or carboplatin in PD-L1 selected participants with chemotherapy-naive, Stage IV squamous NSCLC. The study was closed due to low patient enrollment and the Sponsor's decision to include patients with squamous NSCLC into the GO29431 study, NCT02409342. Therefore the planned objectives of this study are no longer applicable and formal analyses of efficacy or safety have not been performed.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically confirmed Stage IV squamous NSCLC
• Tumor programmed death-ligand 1 (PD-L1) expression, as determined by immunohistochemistry (IHC) assay of archival tumor tissue or tissue obtained at screening
• No prior treatment for Stage IV squamous NSCLC
• Measurable disease as defined by RECIST v1.1
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Adequate hematologic and end-organ function

Exclusion criteria

• Active or untreated central nervous system (CNS) metastases
• Untreated or inadequately treated spinal cord compression
• Leptomeningeal disease
• Uncontrolled pleural effusion, pericardial effusion, or ascites
• Uncontrolled tumor-related pain
• Uncontrolled hypercalcemia
• Any other malignancies within 5 years except those with negligible risk of metastasis or death
• Pregnant or lactating women
• Known hypersensitivity to any component of atezolizumab formulation or other study medication
• History of autoimmune disease except controlled, treated hypothyroidism or type I diabetes
• Prior allogeneic bone marrow or solid organ transplantation
• Positive human immunodeficiency virus (HIV) test
• Active hepatitis B or C
• Active tuberculosis
• Significant cardiovascular disease
• Severe infection or major surgery within 4 weeks prior to randomization
• Use of any approved anti-cancer therapy within 3 weeks prior to treatment
• Use of an investigational agent or participation in another clinical trial within 4 weeks prior to randomization
• Exposure to oral or IV antibiotics within 2 weeks or live attenuated vaccines within 4 weeks prior to randomization
• Prior treatment with cluster of differentiation (CD) 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibodies
• Treatment with immunostimulatory agents within 4 weeks or immunosuppressive agents within 2 weeks prior to randomization

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

Atezolizumab

Experimental group

Description:

Participants will receive intravenous (IV) infusion of atezolizumab once on Day 1 of each 21-day cycle until loss of clinical benefit.

Treatment:

Drug: Atezolizumab

Gemcitabine + Cisplatin/Carboplatin

Active Comparator group

Description:

Participants will receive IV infusion of gemcitabine + cisplatin or gemcitabine + carboplatin once on Day 1 of each 21-day cycle for four or six cycles as per local standard of care.

Treatment:

Drug: Cisplatin

Drug: Gemcitabine

Drug: Carboplatin