← Back to Search

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
Male participants must not donate sperm during the treatment period and for 90 days after the final dose of tiragolumab
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12, 24, 36 and 48 months
Awards & highlights

SKYSCRAPER-03 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.Check my eligibility
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.See study design
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.

SKYSCRAPER-03 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My lung cancer is at an advanced stage and cannot be removed by surgery.
Select...
I will not donate sperm during and for 3 months after treatment.
Select...
My radiotherapy was 54-66 Gy using advanced techniques.
Select...
I will not have unprotected sex for 90 days after my last dose of the medication.
Select...
I am fully active or can carry out light work.
Select...
I had a PET-CT scan within the last 42 days before starting chemoradiotherapy.
Select...
My cancer did not worsen during or after platinum-based chemo and radiation therapy.
Select...
My blood and organs are functioning well.
Select...
I know my PD-L1 status.
Select...
I've completed at least two cycles of chemotherapy with radiation within the last 42 days.

SKYSCRAPER-03 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12, 24, 36 and 48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12, 24, 36 and 48 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
IRF-assessed PFS in the Full Analysis Set (FAS)
Independent Review Facility (IRF)-assessed Progression Free Survival (PFS) in the PD-L1-positive Analysis Set (PPAS)
Secondary outcome measures
IRF-assessed Confirmed ORR in the FAS
IRF-assessed Confirmed Objective Response Rate (ORR) in the PPAS
IRF-assessed DOR in the FAS
+20 more

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%
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-03 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
2020
Completed Phase 2
~350
Atezolizumab
2017
Completed Phase 3
~5860

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,088,225 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,199 Previous Clinical Trials
887,673 Total Patients Enrolled

Media Library

Atezolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04513925 — Phase 3
Non-Small Cell Lung Cancer Research Study Groups: Atezolizumab + Tiragolumab, Durvalumab
Non-Small Cell Lung Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT04513925 — Phase 3
Atezolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04513925 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are we still looking for participants in this experiment?

"The listed clinical trial on clinicaltrials.gov is searching for participants, with the posting date being 8/24/2020 and the last update on 10/26/2022."

Answered by AI

What is the FDA-approved use for Atezolizumab?

"Atezolizumab is commonly used to treat disease, though it can also be prescribed for other ailments such as small cell lung cancer (sclc) and unresectable stage iii non-small cell lung cancer."

Answered by AI

Are there any serious risks associated with Atezolizumab?

"Atezolizumab's safety is well-documented, as it has progressed to Phase 3 clinical trials. Consequently, our team rated its risk at a 3."

Answered by AI

Is this trial being conducted in more than one state in the US?

"This trial is being conducted at 33 different locations, some of which are Monument Health Rapid City Hospital, Inc. in Rapid City, Northwell Health in New Hyde Park, and Orange Coast Memorial Medical Center in Fountain Valley."

Answered by AI

How many research participants are allowed to enroll in this study?

"Yes, the clinicaltrials.gov website indicates that this study is open for recruitment. This particular trial was posted on August 24th 2020 and was last edited on October 26th 2020. The researchers are looking to enroll 800 patients from 33 different sites in total."

Answered by AI

Is this a brand new clinical study?

"Atezolizumab has been researched since 2008, when the first study was sponsored by Hoffmann-La Roche. After the initial trial with 720 participants, Atezolizumab received Phase 2 drug approval in ____. There are currently 685 live trials for Atezolizumab being conducted across 1995 cities and 76 countries."

Answered by AI

What other scientific literature is there on Atezolizumab?

"There are currently 685 clinical trials underway to study the efficacy of Atezolizumab. Out of those, 121 are in Phase 3. The high number of trials for this medication is largely due to its promising effects and availability; However, these studies are not limited to Port Huron, Michigan as there are over 30 thousand locations running similar investigations."

Answered by AI

Who else is applying?

What site did they apply to?
Cox Health Systems
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

What questions have other patients asked about this trial?

I do have a question, what is the difference beteewn small cell and non small cell? I have small cell. Am I Appling for the right trail?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

Ive done Chemo it shunk my tumor. But I want to hopefully get a treatment to make it go away.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
A Study of Atezolizumab and Tiragolumab Compared With Durvalumab in Participants With Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC)
2020. "A Study of Atezolizumab and Tiragolumab Compared With Durvalumab in Participants With Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04513925.
All > Lung Cancer Boston
~99 spots leftby Oct 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top