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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]

NCT02409342 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 572

Last updated 2023-03-15

Study results available
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Summary

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.

Conditions

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

Interventions

DRUG

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).

DRUG

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.

DRUG

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.

DRUG

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.

DRUG

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).

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-20
Primary Completion
2020-02-04
Completion
2022-03-08

Countries

  • United States
  • Brazil
  • China
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Japan
  • Poland
  • Romania
  • Russia
  • Serbia
  • South Korea
  • Spain
  • Thailand
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02409342 on ClinicalTrials.gov