Atezolizumab and Tiragolumab in Patients With NSCLC or Advanced Solid Tumors Having Had Prior Treatment With a PD-1 Inhibitor

Conditions

• Non-Small Cell Lung Cancer
• Solid Tumor

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Atezolizumab — DRUG
  Atezolizumab at a flat dose of 1200 mg IV every 3 weeks
• Standard of Care Chemotherapy — DRUG
  Platinum-based standard of care doublet chemotherapy (or triplet if bevacizumab is used) will be given by IV every 3 weeks. Platinum chemotherapy may be cisplatin or carboplatin chosen based on histology and at the discretion of the treating investigator. It should be administered according to the directions in the approved labeling.
• Tiragolumab — DRUG
  Tiragolumab at a flat dose of 600 mg IV every 3 weeks

Study Details

This is a Phase II, two part trial (A and B), open label study of Atezolizumab and tiragolumab, or atezolizumab combined with SOC chemotherapy in patients with NSCLC or advanced solid tumors that have had prior treatment with a PD-1 inhibitor (e.g. nivolumab or pembrolizumab).

Key Dates

Start date

Aug 30, 2019

Status verified

Aug 2025

Primary completion

Aug 9, 2024

Completion

Aug 9, 2024

Study Design

Enrollment

46 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A1 (NSCLC Chemo + Atezolizumab)
  Arm A NSCLC participants randomized to receive chemotherapy plus atezolizumab at a flat dose of 1200 mg intravenously (IV) every 3 weeks. Standard of care chemotherapy is defined as a platinum-doublet therapy (or triplet if bevacizumab is used) of the Investigator's choice.
• Experimental: Arm B (Atezolizumab only)
  In Arm B, non-randomized participants with specific advanced solid tumors will be treated with atezolizumab at a flat dose of 1200 mg IV every 3 weeks until progression or unacceptable toxicity.
• Active Comparator: Arm A2 (NSCLC Standard of Care Chemo)
  Arm A NSCLC participants randomized to receive platinum-based standard of care doublet chemotherapy (or triplet if bevacizumab is used) will be given by IV every 3 weeks. Platinum chemotherapy may be cisplatin or carboplatin chosen based on histology and at the discretion of the treating investigator. Arm A2 closed early due to change in recommended Standard of Care therapies.
• Experimental: Arm B (Atezolizumab and Tiragolumab)
  In Arm B, non-randomized participants with specific advanced solid tumors will be treated with atezolizumab at a flat dose of 1200 mg IV and tiragolumab at a flat dose of 600mg IVevery 3 weeks until progression or unacceptable toxicity. The addition of tiragolumab was a later update to protocol. No randomization into or within Arm B.

Primary Outcome Measure

Overall Response Rate [ Time Frame: Every 8 weeks until tumor progression or treatment discontinuation, up to 52 months. ]

Locations (7)

Related coverage on Hipa.ai

• Atezolizumab + Chemo Improves Response in Prior-Treated NSCLC
  Atezolizumab · Aug 27, 2025 · ClinicalTrials.gov

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