What is the mechanism of action of this treatment?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) often involve immune checkpoint inhibitors like tiragolumab and atezolizumab. Tiragolumab targets the TIGIT protein on T cells, enhancing their ability to attack cancer cells. Atezolizumab inhibits the PD-L1 protein on tumor cells, preventing them from evading immune detection. These mechanisms are important for NSCLC patients as they can improve the immune system's ability to fight cancer, potentially leading to better outcomes and prolonged survival.

What side effects are associated with this type of intervention?

Common treatments for NSCLC, particularly those involving immunotherapies like Atezolizumab, Pembrolizumab, and Nivolumab, often have side effects that include fatigue, rash, diarrhea, and pruritus. Severe treatment-related adverse effects can include pneumonitis, colitis, hepatitis, and endocrinopathies. When combined with chemotherapy, these immunotherapies can also lead to increased rates of severe adverse events such as neutropenia, anemia, and thrombocytopenia. The combination of Tiragolumab and Atezolizumab specifically has shown a safety profile generally similar to Atezolizumab alone, with manageable side effects.

What prior FDA approvals exist?

Atezolizumab, an anti-PD-L1 antibody, is FDA-approved for front-line treatment of NSCLC with high PD-L1 expression and for patients whose disease progressed after platinum-containing chemotherapy. Pembrolizumab, targeting PD-1, is approved for tumors with PD-L1 expression (≥1%) and is effective in both first-line and subsequent treatments. Nivolumab, another anti-PD-1 antibody, is approved for NSCLC after progression on platinum-based chemotherapy. These approvals underscore the importance of immune checkpoint inhibitors in NSCLC treatment, similar to the tiragolumab and atezolizumab combination under study.

What other types of research exist?

Promising alternatives to Tiragolumab plus Atezolizumab for NSCLC patients include: 1) Pembrolizumab (Anti-PD-1) plus chemotherapy, which has shown improved overall survival in patients with PD-L1 expression. 2) Nivolumab (Anti-PD-1) plus Ipilimumab (Anti-CTLA-4), which has demonstrated efficacy in various trials. 3) Ramucirumab plus Pembrolizumab, which has shown improved overall survival in patients with progressive disease after initial immunotherapy. These alternatives offer different mechanisms of action and have shown promising results in clinical trials.

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Checkpoint Inhibitor

Tiragolumab + Atezolizumab for Lung Cancer (SKYSCRAPER-15 Trial)

Phase 3

Recruiting

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group performance status of 0 or 1

Participants must have received between one to four cycles of adjuvant histology-based platinum doublet chemotherapy

Must not have

Any evidence of residual disease or disease recurrence following surgical resection of NSCLC, or during or following adjuvant chemotherapy

NSCLC known to have mutation in the EGFR gene or an ALK fusion oncogene

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

Summary

This trial is testing whether adding tiragolumab to atezolizumab is more effective than using atezolizumab alone in patients with non-small cell lung cancer who have had surgery and chemotherapy. The goal is to see if this combination can better help the immune system fight cancer. The study compares the new combination to atezolizumab alone to measure its effectiveness and safety.

Who is the study for?

This trial is for people who have had surgery to remove non-small cell lung cancer and completed chemotherapy. Participants should be in good health post-surgery with no evidence of the cancer returning.

What is being tested?

The study tests if adding Tiragolumab to Atezolizumab (both are immunotherapy drugs) is better than using a placebo with Atezolizumab after lung cancer surgery and chemo.

What are the potential side effects?

Possible side effects include immune-related reactions, such as inflammation in various organs, fatigue, infusion reactions similar to allergic responses, and potential increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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I've had 1-4 rounds of specific chemotherapy for my cancer.

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My tumor shows PD-L1 expression of 1% or more.

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My lung cancer is at a specific advanced stage but not the most severe.

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I had surgery to completely remove my lung cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My lung cancer came back or didn't fully go away after surgery or chemotherapy.

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My lung cancer has an EGFR mutation or ALK fusion.

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I have had non-small cell lung cancer in the past 5 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Atezolizumab + TiragolumabExperimental Treatment2 Interventions

Participants will receive atezolizumab and tiragolumab intravenously (IV).

Group II: Atezolizumab + PlaceboPlacebo Group2 Interventions

Participants will receive atezolizumab and placebo IV.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2016

Completed Phase 3

~5860

Tiragolumab

2019

Completed Phase 3

~1390

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Non-Small Cell Lung Cancer (NSCLC) often involve immune checkpoint inhibitors like tiragolumab and atezolizumab. Tiragolumab targets the TIGIT protein on T cells, enhancing their ability to attack cancer cells. Atezolizumab inhibits the PD-L1 protein on tumor cells, preventing them from evading immune detection. These mechanisms are important for NSCLC patients as they can improve the immune system's ability to fight cancer, potentially leading to better outcomes and prolonged survival.

Tiragolumab plus atezolizumab versus placebo plus atezolizumab as a first-line treatment for PD-L1-selected non-small-cell lung cancer (CITYSCAPE): primary and follow-up analyses of a randomised, double-blind, phase 2 study.Chemotherapy in Combination With Immune Checkpoint Inhibitors for the First-Line Treatment of Patients With Advanced Non-small Cell Lung Cancer: A Systematic Review and Literature-Based Meta-Analysis.