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Checkpoint Inhibitor

Atezolizumab + Tiragolumab for Lung Cancer (SKYSCRAPER-03 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 documented NSCLC with locally advanced, unresectable Stage III NSCLC of either squamous or non-squamous histology

The radiotherapy (RT) component in the cCRT must have been at a total dose of radiation of 60 (±10 percent [%]) gray (Gy) (54 Gy to 66 Gy) administered by intensity modulated RT (preferred) or 3D-conforming technique

Must not have

Treatment with systemic immunosuppressive medication

Any history of prior NSCLC and/or any history of prior treatment for NSCLC (participants must be newly diagnosed with unresectable Stage III disease)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 114 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a new immunotherapy combination to see if it's more effective than another immunotherapy drug in people with NSCLC who have had chemoradiotherapy.

Who is the study for?

This trial is for adults with Stage III non-small cell lung cancer (NSCLC) who've had some chemo and radiation but no disease progression. They need to be in good health overall, not pregnant, willing to use contraception, and have a life expectancy of at least 12 weeks. People can't join if they've had certain previous treatments for NSCLC or other cancers, specific gene mutations in their cancer, unresolved side effects from past treatments, autoimmune diseases, or are on immunosuppressive drugs.

What is being tested?

The study tests the effectiveness and safety of combining two drugs: Atezolizumab and Tiragolumab versus Durvalumab alone. All participants previously received platinum-based chemoradiotherapy without their cancer getting worse. The goal is to see which combination works better after this initial treatment.

What are the potential side effects?

Potential side effects include immune-related reactions that could affect various organs like the lungs (pneumonitis), liver problems, skin issues such as rash or itching, hormone gland changes leading to different symptoms depending on the gland affected (like thyroid issues), fatigue, nausea and possible infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

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

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My lung cancer is at an advanced stage and cannot be removed by surgery.

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My radiotherapy was 54-66 Gy using advanced techniques.

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I am fully active or can carry out light work.

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My cancer did not worsen during or after platinum-based chemo and radiation therapy.

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I know my PD-L1 status.

Exclusion Criteria

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

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I am taking medication that weakens my immune system.

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I have been newly diagnosed with Stage III lung cancer that cannot be surgically removed.

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My NSCLC has an EGFR mutation or ALK fusion.

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I have previously been treated with specific immune therapies.

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My cancer has spread to distant parts of my body.

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My advanced lung cancer worsened after my last major treatment.

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I have no major side effects from previous cancer treatments.

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I have had severe lung inflammation from previous cancer treatments.

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I have had a previous transplant of stem cells or an organ.

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I have an active Epstein-Barr virus infection.

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I am not pregnant or breastfeeding.

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I have a history of lung inflammation not caused by infections.

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I am receiving a specific treatment sequence for advanced lung cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 114 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 114 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 114 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

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 PPAS

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227

36%

Fatigue

35%

Alopecia

24%

Diarrhoea

23%

Nausea

23%

Decreased appetite

22%

Anaemia

20%

Asthenia

19%

Cough

19%

Dyspnoea

16%

Myalgia

15%

Neutropenia

14%

Constipation

14%

Oedema peripheral

12%

Pyrexia

11%

Stomatitis

11%

Vomiting

11%

Neuropathy peripheral

10%

Arthralgia

Neutrophil count decreased

Rash

Dysgeusia

Headache

Paraesthesia

Pain in extremity

Mucosal inflammation

Back pain

Peripheral sensory neuropathy

Insomnia

Febrile neutropenia

Pneumonia

Lacrimation increased

Abdominal pain

Dry skin

Dizziness

Malaise

Urinary tract infection

Weight decreased

Haemoptysis

Nail disorder

Chest pain

Nasopharyngitis

Musculoskeletal pain

Bronchitis

Productive cough

Upper respiratory tract infection

Pruritus

Influenza like illness

Alanine aminotransferase increased

Aspartate aminotransferase increased

Syncope

Dehydration

Atrial fibrillation

Lower respiratory tract infection

Lung infection

Respiratory tract infection

Acute kidney injury

Chronic obstructive pulmonary disease

Pleural effusion

Depression

Musculoskeletal chest pain

100%

80%

60%

40%

20%

Study treatment Arm

Docetaxel

Atezolizumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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: Atezolizumab + TiragolumabExperimental Treatment2 Interventions

Participants will receive atezolizumab administered intravenously (IV) on Day 1 of each 28-day cycle followed by tiragolumab administered IV on Day 1 of each 28-day cycle for a maximum of 13 cycles.

Group II: DurvalumabActive Control1 Intervention

Participants will receive durvalumab administered IV during each 28-day cycle for a maximum of 13 cycles.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tiragolumab

2019

Completed Phase 3

~2330

Atezolizumab

2016