NCT04611776

A Study Evaluating the Efficacy and Safety of Adjuvant Platinum-Doublet Chemotherapy, With or Without Atezolizumab, in Patients Who Are ctDNA Positive After Complete Surgical Resection of Stage IB to Select IIIB Non-Small Cell Lung Cancer

A Phase II, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Adjuvant Platinum-Doublet Chemotherapy, With or Without Atezolizumab, in Patients Who Are ctDNA Positive After Complete Surgical Resection of Stage IB to Select IIIB Non-Small Cell Lung Cancer

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II, multicenter, double-blind, randomized study designed to evaluate the efficacy and safety of adjuvant treatment with atezolizumab in combination with platinum-doublet chemotherapy followed by atezolizumab compared with adjuvant placebo in combination with platinum-doublet chemotherapy followed by placebo in patients with Stage IB to IIIB (T3N2) NSCLC following surgical resection who are positive for ctDNA.

Conditions

• Carcinoma, Non-Small Cell Lung

Interventions

Type	Name	Description
DRUG	Atezolizumab	Atezolizumab will be administered intravenously during the induction phase and the maintenance phase.
DRUG	Placebo	Placebo will be administered intravenously during the induction phase and the maintenance phase.
DRUG	Carboplatin	Carboplatin will be administered intravenously during the induction phase.
DRUG	Cisplatin	Cisplatin will be administered intravenously during the induction phase.
DRUG	Pemetrexed	Pemetrexed will be administered intravenously during the induction phase.
DRUG	Gemcitabine	Gemcitabine will be administered intravenously during the induction phase.
DRUG	Paclitaxel	Paclitaxel will be administered intravenously during the induction phase.

Timeline

• Start date: 2021-07-01
• Primary completion: 2025-03-06
• Completion: 2026-01-08
• First posted: 2020-11-02
• Last updated: 2021-06-16

Regulatory

• FDA-regulated drug study