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

Sponsor
Hoffmann-La Roche
Study ID
NCT04611776
Phase
PHASE2
Status
Withdrawn

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 intravenously during the induction phase and the maintenance phase.
  • Placebo — DRUG
    Placebo will be administered intravenously during the induction phase and the maintenance phase.
  • Carboplatin — DRUG
    Carboplatin will be administered intravenously during the induction phase.
  • Cisplatin — DRUG
    Cisplatin will be administered intravenously during the induction phase.
  • Pemetrexed — DRUG
    Pemetrexed will be administered intravenously during the induction phase.
  • Gemcitabine — DRUG
    Gemcitabine will be administered intravenously during the induction phase.
  • Paclitaxel — DRUG
    Paclitaxel will be administered intravenously during the induction phase.

Study Details

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.

Key Dates

Start date
Jul 1, 2021
Status verified
Jun 2021
Primary completion
Mar 6, 2025
Completion
Jan 8, 2026

Study Design

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

Arms

  • Experimental: Arm A: Atezolizumab + platinum-doublet followed by atezolizumab maintenance
  • Placebo Comparator: Arm B: Placebo + platinum-doublet followed by placebo maintenance

Primary Outcome Measure

ctDNA Clearance Rate at 6 Months [ Time Frame: Randomization up to 6 months ]

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