A Study of the Efficacy and Safety of RO7198457 in Combination With Atezolizumab Versus Atezolizumab Alone Following Adjuvant Platinum-Doublet Chemotherapy in Participants Who Are ctDNA Positive After Surgical Resection of Stage II-III Non-Small Cell Lung Cancer

Sponsor
Hoffmann-La Roche
Study ID
NCT04267237
Phase
PHASE2
Status
Withdrawn

Conditions

  • Non-small Cell Lung Cancer (NSCLC)

Eligibility Criteria

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

Interventions

  • Atezolizumab — DRUG
    Atezolizumab 1680 mg will be administered by intravenous (IV) infusion on Day 1 of Cycles 1-12.
  • RO7198457 — DRUG
    RO7198457 will be administered by IV infusion at protocol-defined intervals for 12 cycles.

Study Details

This study will evaluate the efficacy, safety, pharmacokinetics, immunogenicity and biomarkers of RO7198457 plus atezolizumab compared with atezolizumab alone in patients with Stage II-III non-small cell lung cancer (NSCLC) who are circulating tumor DNA (ctDNA) positive following surgical resection and have received standard-of-care adjuvant platinum-doublet chemotherapy.

Key Dates

Start date
Mar 31, 2021
Status verified
Feb 2021
Primary completion
Sep 30, 2025
Completion
Sep 30, 2025

Study Design

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

Arms

  • Experimental: Atezolizumab
    Participants will receive atezolizumab on Day 1 of each 28-day cycle (Q4W) for 12 cycles.
  • Experimental: Atezolizumab + RO7198457
    Participants will receive atezolizumab Q4W along with RO7198457 for 12 cycles.

Primary Outcome Measure

Disease-free Survival (DFS) [ Time Frame: Up to 62 months ]

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