NCT04194203

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)

A Phase III, Randomized, Double-Blind 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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 305 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	Atezolizumab	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.
DRUG	Placebo	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.
DRUG	Bevacizumab	Bevacizumab will be administered by IV infusion at a dose of 15 mg/kg on Day 1 of each 21-day cycle.
DRUG	Paclitaxel	Paclitaxel will be administered by IV infusion at a dose of 175 mg/m2.
DRUG	Pemetrexed	Pemetrexed will be administered by IV infusion at a dose of 500 mg/m2.
DRUG	Carboplatin	Carboplatin will be administered by IV infusion to achieve an initial target AUC of 6 mg/mL/min.

Timeline

• Start date: 2020-04-09
• Primary completion: 2023-02-02
• Completion: 2024-06-27
• First posted: 2019-12-11
• Last updated: 2024-07-19

Locations

23 sites across 1 country: China