Atezolizumab Immunotherapy With or Without Tiragolumab for Patients With Unresectable Stage III NSCLC

Conditions

• NSCLC

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Atezolizumab — DRUG
  Atezolizumab will be given to participants either intravenously at a dosage of 1200mg or subcutaneously at a dosage of 1875 mg on Day 1 of each 21-day cycle for Arms A, B, and C, and on days 1 and 22 of concurrent chemoradiotherapy for Arm C only.
• Tiragolumab — DRUG
  Tiragolumab will be given to participants intravenously at a dosage of 600 mg on day 1 of each 21-day cycle (Arms B and C), and on days 1 and 22 of concurrent chemoradiotherapy (Arm C only).

Study Details

This is a phase II trial of neoadjuvant and adjuvant atezolizumab with or without tiragolumab in conjunction with chemoradiotherapy for unresectable stage III NSCLC.

Key Dates

Start date

Dec 7, 2023

Status verified

Jul 2025

Primary completion

Nov 30, 2026

Completion

Nov 30, 2026

Study Design

Enrollment

178 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A: Atezolizumab
  79 participants will be randomized 1:1 to Arm A. Participants in Arm A will receive induction immunotherapy with atezolizumab on Day 1 of each cycle, concurrent chemoradiotherapy, and adjuvant atezolizumab Day 1 of each cycle.
• Experimental: Arm B: Atezolizumab and Tiragolumab
  79 participants will be randomized 1:1 to Arm B. Participants in Arm B will receive induction immunotherapy with atezolizumab plus tiragolumab on Day 1 of each cycle, concurrent chemoradiotherapy, and adjuvant atezolizumab plus tiragolumab on Day 1 of each cycle.
• Experimental: Arm C: Atezolizumab and Tiragolumab
  An additional pilot cohort of 20 patients will be accrued at selected sites towards the end of the overall accrual period and after initial safety evaluations of the addition of tiragolumab to atezolizumab before and after chemoradiotherapy. Participants enrolled to Arm C will receive induction immunotherapy with atezolizumab plus tiragolumab on Day 1 of each cycle, concurrent atezolizumab plus tiragolumab with chemoradiotherapy, and adjuvant atezolizumab plus tiragolumab on Day 1 of each 21 cycle.

Primary Outcome Measure

To determine the progression-free survival (PFS) of patients treated with neoadjuvant, concurrent and adjuvant atezolizumab with or without tiragolumab. [ Time Frame: 2 years ]

Locations (15)

Find similar trials in La Jolla, CA

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