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)

Study Overview
=================
Brief Summary
-----------------
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 Therefore the planned objectives of this study are no longer applicable and formal analyses of efficacy or safety have not been performed.

Official Title
-----------------
A Phase III, Open-Label, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Compared With Gemcitabine+Cisplatin or Carboplatin for PD-L1-Selected, Chemotherapy Naive Patients With Stage IV Squamous Non-Small Cell Lung Cancer

Conditions
-----------------
Non-Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: Atezolizumab
* Drug: Carboplatin
* Drug: Cisplatin
* Drug: Gemcitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atezolizumab<br>Participants will receive intravenous (IV) infusion of atezolizumab once on Day 1 of each 21-day cycle until loss of clinical benefit. | Drug: Atezolizumab<br>* Atezolizumab will be administered at a dose of 1200 milligrams (mg) by IV infusion on Day 1 of each 21-day cycle until loss of clinical benefit.<br>* Other names: MPDL3280A; Tecentriq;|
| Active Comparator: Gemcitabine + Cisplatin/Carboplatin<br>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. | Drug: Carboplatin<br>* Carboplatin will be administered at area under the concentration-time curve (AUC) 5 IV infusion once on Day 1 of each 21-day cycle for 4 or 6 cycles.<br>Drug: Cisplatin<br>* Cisplatin will be administered at 75 milligrams per square meter (mg/m^2) IV infusion once on Day 1 of each 21-day cycle for 4 or 6 cycles.<br>Drug: Gemcitabine<br>* Gemcitabine will be administered at 1000 mg/m^2 (when coadministered with carboplatin) or 1250 mg/m^2 (when coadministered with cisplatin) IV infusion on Days 1 and 8 of each 21-day cycle for 4 or 6 cycles.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) |  | Baseline up to death or disease progression, whichever occurs first (up to approximately 2.5 years) |