A Study of Bevacizumab, Carboplatin, and Paclitaxel or Pemetrexed With or Without Atezolizumab in Chemotherapy-Naïve Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer (IMpower151)

Sponsor
Hoffmann-La Roche
Study ID
NCT04194203
Phase
PHASE3
Status
Completed

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    Atezolizumab will be administered by IV infusion at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit.
  • Placebo — DRUG
    Placebo matching to atezolizumab will be administered by IV infusion at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit.
  • Bevacizumab — DRUG
    Bevacizumab will be administered by IV infusion at a dose of 15 mg/kg on Day 1 of each 21-day cycle.
  • Paclitaxel — DRUG
    Paclitaxel will be administered by IV infusion at a dose of 175 mg/m2.
  • Pemetrexed — DRUG
    Pemetrexed will be administered by IV infusion at a dose of 500 mg/m2.
  • Carboplatin — DRUG
    Carboplatin will be administered by IV infusion to achieve an initial target AUC of 6 mg/mL/min.

Study Details

This study will evaluate the efficacy and safety of atezolizumab when given in combination with bevacizumab, investigator's choice of either paclitaxel or pemetrexed, and carboplatin compared with placebo given in combination with bevacizumab, paclitaxel or pemetrexed, and carboplatin in patients with chemotherapy-naive, Stage IV non-squamous Non-Small Cell Lung Cancer (NSCLC). The study will be conducted in two phases: Induction Phase and Maintenance Phase.

Key Dates

Start date
Apr 9, 2020
Status verified
Jul 2024
Primary completion
Feb 2, 2023
Completion
Jun 27, 2024

Study Design

Enrollment
305 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment A
    Participants will receive atezolizumab, bevacizumab, paclitaxel or pemetrexed, and carboplatin (in this order) by intravenous (IV) injection on Day 1 of each 21-day cycle for 4 cycles in the induction treatment. In the maintenance phase, participants will be treated with atezolizumab, bevacizumab and pemetrexed (if given in the induction phase) until unacceptable toxicity or loss of clinical benefit.
  • Placebo Comparator: Treatment B
    Participants will receive placebo, bevacizumab, paclitaxel or pemetrexed, and carboplatin (in this order) by intravenous (IV) injection on Day 1 of each 21-day cycle for 4 cycles in the induction treatment. In the maintenance phase, participants will be treated with placebo, bevacizumab and pemetrexed (if given in the induction phase) until unacceptable toxicity or loss of clinical benefit.

Primary Outcome Measure

Progression Free Survival (PFS) in the intent to treat (ITT) population, as determined by the investigator [ Time Frame: Randomization until the first occurence of disease progression or death from any cause, whichever occures first (up to approximately 33 months) ]

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