A Study Evaluating the Safety and Efficacy of Neoadjuvant and Adjuvant Tiragolumab Plus Atezolizumab, With or Without Platinum-Based Chemotherapy, in Participants With Previously Untreated Locally Advanced Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer

Part of paid clinical trials in Duarte, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT04832854
Phase
PHASE2
Status
Terminated

Conditions

  • Non-Small Cell Lung Cancer (NSCLC)

Eligibility Criteria

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

Interventions

  • Atezolizumab — DRUG
    Atezolizumab 1200 mg will be administered by intravenous (IV) infusion on Day 1 of each 21-day cycle.
  • Tiragolumab — DRUG
    Tiragolumab 600 mg will be administered by IV infusion on Day 1 of each 21-day cycle.
  • Carboplatin — DRUG
    Carboplatin at initial target area under the concentration curve (AUC) of 5 or 6 mg/mL/min will be administered by IV infusion on Day 1 of each 21-day cycle.
  • Cisplatin — DRUG
    Cisplatin at 75 mg/m\^2 will be administered by IV infusion on Day 1 of each 21-day cycle.
  • Pemetrexed — DRUG
    Pemetrexed at 500 mg/m\^2 will be administered by IV infusion on Day 1 of each 21-day cycle.
  • Gemcitabine — DRUG
    Gemcitabine at 1000 or 1250 mg/m\^2 will be administered by IV infusion on Days 1 and 8 of each 21-day cycle.
  • Paclitaxel — DRUG
    Paclitaxel at 175 or 200 mg/m\^2 will be administered by IV infusion on Day 1 of each 21-day cycle.

Study Details

This study will evaluate the surgical safety and feasibility of atezolizumab plus tiragolumab alone or in combination with platinum-based chemotherapy as neoadjuvant treatment for participants with previously untreated locally advanced non-small cell lung cancer (NSCLC). The study will also evaluate the efficacy, pharmacokinetics, immunogenicity, and safety of atezolizumab plus tiragolumab alone or in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by adjuvant atezolizumab plus tiragolumab or adjuvant platinum-based chemotherapy.

Key Dates

First listed
Apr 6, 2021
Start date
Apr 23, 2021
Status verified
Mar 2026
Primary completion
Mar 5, 2025
Completion
Mar 5, 2025

Study Design

Enrollment
50 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A (PD-L1 High)
    Participants with high programmed death-ligand 1 (PD-L1) expression level will be enrolled in Cohort A and receive neoadjuvant atezolizumab plus tiragolumab for 4 cycles, followed by surgical resection and either adjuvant atezolizumab plus tiragolumab for 16 cycles or adjuvant chemotherapy for 4 cycles at the discretion of the investigator. Chemotherapy may include: * cisplatin/carboplatin + pemetrexed (for non-squamous only) * carboplatin + gemcitabine (for squamous only) * carboplatin + paclitaxel
  • Experimental: Cohort B (PD-L1 All Comers)
    All comers, which are participants with any PD-L1 expression level, will be enrolled in Cohort B and receive neoadjuvant atezolizumab plus tiragolumab plus chemotherapy for 4 cycles, followed by surgical resection and adjuvant atezolizumab plus tiragolumab for 16 cycles. Chemotherapy may include: * cisplatin/carboplatin + pemetrexed (for non-squamous only) * carboplatin + gemcitabine (for squamous only) * carboplatin + paclitaxel

Primary Outcome Measure

Number of Participants With Surgical Delays [ Time Frame: Up to approximately 4.7 months ]

Locations (6)

FacilityCityStateZIPSite coordinators
City of Hope Cancer CenterDuarteCalifornia91010-
University of Southern CaliforniaLos AngelesCalifornia90033-
Washington University School of MedicineSt LouisMissouri63110-
Winthrop Univ HospitalMineolaNew York11501-
Columbia UniversityNew YorkNew York10032-3725-
NYU Cancer CenterNew YorkNew York10016-

Related coverage on Hipa.ai

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By research site
City of Hope Cancer Center· Duarte, CAUniversity of Southern California· Los Angeles, CAWashington University School of Medicine· St Louis, MOWinthrop Univ Hospital· Mineola, NYColumbia University· New York, NYNYU Cancer Center· New York, NY

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