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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

NCT04611776 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2021-06-16

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2025-03-06
Completion
2026-01-08
FDA Drug
Yes

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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 NCT04611776 on ClinicalTrials.gov