← Back to Search

Monoclonal Antibodies

Tiragolumab + Atezolizumab for Non-Small Cell Lung Cancer (SKYSCRAPER-01 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

No prior systemic treatment for metastatic NSCLC

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Must not have

Symptomatic, untreated, or actively progressing central nervous system metastases

Known mutation in the EGFR gene or an ALK fusion oncogene

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization until the first confirmed clinically meaningful deterioration (up to approximately 59 months)

Awards & highlights

Pivotal Trial

Summary

This trial is testing a new combination of drugs to treat lung cancer that hasn't been treated before. The drugs are tiragolumab and atezolizumab, which will be given either with or without placebo. The goal is to see if the combination of tiragolumab and atezolizumab is more effective and has fewer side effects than atezolizumab given with placebo.

Who is the study for?

This trial is for adults with advanced non-small cell lung cancer (NSCLC) that has high PD-L1 expression, no prior treatments for metastatic NSCLC, and no EGFR mutations or ALK translocations. Participants should be in good physical condition (ECOG 0 or 1), have measurable disease, and proper organ function. Exclusions include a history of certain lung diseases, previous immune therapy treatments, active hepatitis B/C, HIV positive status, other cancers within the last 5 years except those with low risk.

What is being tested?

The study tests the effectiveness and safety of combining Tiragolumab with Atezolizumab versus a placebo combined with Atezolizumab in untreated advanced NSCLC patients selected based on PD-L1 expression. Patients are randomly assigned to either treatment group in equal numbers.

What are the potential side effects?

Possible side effects may include reactions related to the immune system such as inflammation of organs like lungs or intestines; skin reactions; hormonal gland problems; infusion-related reactions; fatigue; liver issues; and potential increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

Select...

I haven't had any systemic treatment for my advanced lung cancer.

Select...

I am fully active or can carry out light work.

Select...

My lung cancer cannot be cured with surgery or radiotherapy.

Select...

My cancer has high PD-L1 levels.

Exclusion Criteria

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

Select...

I have brain metastases that are untreated or getting worse.

Select...

My cancer has a known EGFR mutation or ALK fusion.

Select...

I have previously been treated with specific immune therapies.

Select...

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

Select...

I have or had an autoimmune disease or immune deficiency.

Select...

I have active hepatitis B or C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization until the first confirmed clinically meaningful deterioration (up to approximately 59 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization until the first confirmed clinically meaningful deterioration (up to approximately 59 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization until the first confirmed clinically meaningful deterioration (up to approximately 59 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

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

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

Headache

Dysgeusia

Paraesthesia

Pain in extremity

Mucosal inflammation

Back pain

Peripheral sensory neuropathy

Insomnia

Pneumonia

Febrile neutropenia

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

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: Tiragolumab + AtezolizumabExperimental Treatment2 Interventions

Participants will receive atezolizumab followed by tiragolumab every 3 weeks (Q3W) on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity.

Group II: Placebo + AtezolizumabPlacebo Group2 Interventions

Participants will receive atezolizumab followed by placebo Q3W on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity.

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