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)

Conditions

• Non-Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Atezolizumab — DRUG
  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.
• Carboplatin — DRUG
  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.
• Cisplatin — DRUG
  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.
• Gemcitabine — DRUG
  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.

Study Details

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 Therefore the planned objectives of this study are no longer applicable and formal analyses of efficacy or safety have not been performed.

Key Dates

Start date

May 7, 2015

Status verified

Feb 2019

Primary completion

Dec 7, 2017

Completion

Dec 7, 2017

Study Design

Enrollment

8 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Atezolizumab
  Participants will receive intravenous (IV) infusion of atezolizumab once on Day 1 of each 21-day cycle until loss of clinical benefit.
• Active Comparator: Gemcitabine + Cisplatin/Carboplatin
  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.

Primary Outcome Measure

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

Locations (28)

Find similar trials in Encinitas, CA

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