Your session is about to expire
← 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months, 24 months
Awards & highlights
SKYSCRAPER-01 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.Check my eligibility
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.See study design
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.
SKYSCRAPER-01 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
SKYSCRAPER-01 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months, 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months, 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Investigator-Assessed Progression-Free Survival (PFS) in the Primary Analysis Set
Overall Survival (OS) in the Primary Analysis Set
Percentage of Participants With Adverse Events (AEs)
+1 moreSecondary outcome measures
Investigator-Assessed Confirmed Objective Response Rate (ORR)
Investigator-Assessed Duration of Response (DOR)
Investigator-Assessed PFS Rates at 6 Months and 12 Months
+4 moreSide effects data
From 2019 Phase 3 trial • 1225 Patients • NCT0200822736%
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%
Neuropathy peripheral
11%
Vomiting
11%
Stomatitis
10%
Arthralgia
9%
Rash
9%
Neutrophil count decreased
8%
Dysgeusia
8%
Paraesthesia
8%
Headache
7%
Pain in extremity
7%
Peripheral sensory neuropathy
7%
Insomnia
7%
Mucosal inflammation
7%
Back pain
6%
Pneumonia
6%
Febrile neutropenia
6%
Abdominal pain
6%
Dry skin
6%
Lacrimation increased
6%
Dizziness
5%
Haemoptysis
5%
Weight decreased
5%
Malaise
5%
Urinary tract infection
5%
Nail disorder
4%
Productive cough
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
3%
Pruritus
3%
Upper respiratory tract infection
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
2%
Influenza like illness
1%
Respiratory tract infection
1%
Musculoskeletal chest pain
1%
Lower respiratory tract infection
1%
Acute kidney injury
1%
Depression
1%
Lung infection
1%
Dehydration
1%
Chronic obstructive pulmonary disease
1%
Atrial fibrillation
1%
Syncope
1%
Pleural effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab
SKYSCRAPER-01 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
2017
Completed Phase 3
~5860
Tiragolumab
2020
Completed Phase 2
~350
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,088,434 Total Patients Enrolled
Clinical TrialStudy DirectorHoffmann-La Roche
9 Previous Clinical Trials
1,650 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have brain metastases that are untreated or getting worse.My cancer has a known EGFR mutation or ALK fusion.I haven't taken any immune-boosting drugs in the last 4 weeks or 5 half-lives before starting the study.I haven't had any systemic treatment for my advanced lung cancer.I am fully active or can carry out light work.I have previously been treated with specific immune therapies.My blood and organs are functioning well.My lung cancer cannot be cured with surgery or radiotherapy.My cancer has high PD-L1 levels.I have a history of lung inflammation not caused by infections.I have not had a severe infection in the last 4 weeks.You have a detectable tumor that can be measured using specific guidelines.You have tested positive for HIV.I have or had an autoimmune disease or immune deficiency.I have active hepatitis B or C.You currently live in mainland China or Taiwan and are of Chinese descent.I haven't had any cancer other than NSCLC in the last 5 years, except for those considered low risk and treated with curative intent.
Research Study Groups:
This trial has the following groups:- Group 1: Tiragolumab + Atezolizumab
- Group 2: Placebo + Atezolizumab
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you name a few of the hospitals conducting this research?
"In addition to SCRI Florida Cancer Specialists North; Research Office North Region in Saint Petersburg, Florida, and Yale Cancer Center in New Haven, Connecticut, this trial is also running out of Rocky Mountain Cancer Center - Denver in Littleton, Colorado, as well as 9 other locations."
Answered by AI
What conditions does Tiragolumab commonly help alleviate?
"Tiragolumab is most often used to treat small cell lung cancer (sclc), but has also shown efficacy in treating other conditions like malignant neoplasms, non-small cell lung carcinoma, and postoperative."
Answered by AI
Is Tiragolumab a common drug used in medical studies?
"The immunotherapy drug tiragolumab was first studied a decade ago at UZ Gent. There are now a total of 518 trials related to tiragolumab, with 159 of these trials completed. Many of the active trials are based in Saint Petersburg, Florida."
Answered by AI
Have these treatments been trialed before?
"There are 359 ongoing Tiragolumab trials in 74 countries and 1665 cities. The first study was completed in 2008 and sponsored by Genentech, Inc. It included 720 patients and reached Phase 2 approval. In the 12 years since, 159 more trials have completed."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger