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Monoclonal Antibodies

Atezolizumab + Chemotherapy for Small Cell Lung Cancer (SKYSCRAPER-02 Trial)

Phase 3

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

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

Must have

Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC)

Treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC

Must not have

Severe infection at the time of randomization

Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-cytotoxic T lymphocyte-associated protein 4 (anti-CTLA-4), anti-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline up to 50 months

Awards & highlights

Pivotal Trial

Summary

This trial will compare tiragolumab plus atezolizumab with placebo plus atezolizumab in people with small cell lung cancer who have not had chemotherapy before.

Who is the study for?

This trial is for adults with untreated extensive-stage small cell lung cancer (ES-SCLC). Participants should have no prior treatments, good organ function, and an ECOG Performance Status of 0 or 1. They can't join if they have autoimmune diseases, active CNS metastases, previous immune therapy use, recent immunostimulatory agents use, other cancers within the last 5 years (except those with low risk), HIV/Hepatitis B/C infections, severe infections at randomization time or a history of certain lung conditions.

What is being tested?

The study tests whether adding Tiragolumab to Atezolizumab plus chemotherapy (Carboplatin and Etoposide) improves outcomes compared to using a placebo with Atezolizumab and the same chemo in ES-SCLC patients. After initial treatment phase ('induction'), participants continue maintenance therapy either with both drugs or one drug plus placebo.

What are the potential side effects?

Possible side effects include reactions related to the immune system such as inflammation in different organs including lungs (pneumonitis), liver issues; infusion-related reactions; fatigue; blood disorders like anemia; increased risk of infections due to weakened immunity.

Eligibility Criteria

Inclusion Criteria

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

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My lung cancer is confirmed to be extensive-stage small cell.

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I haven't had chemo or radiotherapy for my small cell lung cancer in the last 6 months.

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I have not received any systemic treatment for small cell lung cancer.

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I am fully active or can carry out light work.

Exclusion Criteria

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

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I do not have a severe infection currently.

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I have previously received treatments targeting the immune system.

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I have had lung conditions like pulmonary fibrosis or pneumonitis, or my CT scan shows active pneumonitis.

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I have or had an autoimmune disease or immune deficiency.

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My brain cancer is getting worse or causing symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline up to 50 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline up to 50 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to 50 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change from Baseline in EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Index-based and Visual Analog Scale Scores

TTCD Assessed Using EORTC QLQ-C30 Score in the FAS

Time to Confirmed Deterioration (TTCD) Assessed Using European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core (QLQ-C30) Score in the PAS

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

Active Control

Group I: Tiragolumab + Atezolizumab + CEExperimental Treatment4 Interventions

Participants will receive atezolizumab on Day 1 of each 21-day cycle followed by tiragolumab on Day 1 of each 21-day cycle. Carboplatin will be administered followed by etoposide on Day 1 for 4 cycles. Participants will also receive etoposide on Days 2 and 3.

Group II: Placebo + Atezolizumab + CEActive Control4 Interventions

Participants will receive atezolizumab on Day 1 of each 21-day cycle followed by placebo on Day 1 of each 21-day cycle. Carboplatin will be administered followed by etoposide on Day 1 for 4 cycles. Participants will also receive etoposide on Days 2 and 3.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6120

Tiragolumab

2019

Completed Phase 3

~2330