A Study of Atezolizumab (MPDL3280A) Compared With a Platinum Agent (Cisplatin or Carboplatin) + (Pemetrexed or Gemcitabine) in Participants With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower110]

Conditions

• Non-Squamous Non-Small Cell Lung Cancer, Squamous Non-Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody — DRUG
  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).
• Carboplatin — DRUG
  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.
• Cisplatin — DRUG
  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.
• Gemcitabine — DRUG
  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.
• Pemetrexed — DRUG
  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).

Study Details

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.

Key Dates

Start date

Jul 20, 2015

Status verified

Feb 2023

Primary completion

Feb 4, 2020

Completion

Mar 8, 2022

Study Design

Enrollment

572 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
  Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).
• Experimental: Atezolizumab
  Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).

Primary Outcome Measure

Overall Survival (OS) in the TC3 or IC3-WT Populations [ Time Frame: From randomization to death from any cause until data cut-off on 10 September 2018 (up to approximately 38 months) ]

Locations (9)

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