← Back to Search

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months, 24 months
Awards & highlights

SKYSCRAPER-02 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.Check my eligibility
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.See study design
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.

SKYSCRAPER-02 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My lung cancer is confirmed to be extensive-stage small cell.
Select...
I haven't had chemo or radiotherapy for my small cell lung cancer in the last 6 months.
Select...
I have not received any systemic treatment for small cell lung cancer.
Select...
I am fully active or can carry out light work.

SKYSCRAPER-02 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months, 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months, 24 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
Investigator-Assessed Progression Free Survival (PFS) in the Primary Analysis Set (PAS)
Overall Survival (OS) in the PAS
Secondary outcome measures
Change from Baseline in EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Index-based and Visual Analog Scale Scores
Cmax of Atezolizumab
Cmin of Atezolizumab
+17 more

SKYSCRAPER-02 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
~6670
Tiragolumab
2020
Completed Phase 2
~460
Atezolizumab
2017
Completed Phase 3
~5860
Etoposide
2010
Completed Phase 3
~2440

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,432 Previous Clinical Trials
1,089,396 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,113 Total Patients Enrolled

Media Library

Atezolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04256421 — Phase 3
Small Cell Lung Cancer Research Study Groups: Tiragolumab + Atezolizumab + CE, Placebo + Atezolizumab + CE
Small Cell Lung Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT04256421 — Phase 3
Atezolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04256421 — Phase 3

Frequently Asked Questions

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

Is Tiragolumab known to cause any serious health problems?

"There is already some evidence that Tiragolumab is effective and safe, as this is a Phase 3 trial."

Answered by AI

At how many different locations is this trial being run?

"21 medical centres across America are currently recruiting patients for this trial, with locations in cities such as Austin, Denver and Fort Myers. To help reduce the burden of travel, it is best to select the clinical site nearest to you."

Answered by AI

What are the conditions that Tiragolumab is most effective in treating?

"Tiragolumab is most often used to treat recurrent cancer. Additionally, it can be used as part of the care plan for other conditions such as advanced directives, advanced cervical cancer, and gestational trophoblastic disease."

Answered by AI

Are there any available openings for participants in this research?

"This clinical trial is not accepting patients at the moment. It was originally posted on 2020-02-04 and last edited on 2022-09-29. However, there are currently 1606 other trials for small cell lung carcinoma and 1212 trials for Tiragolumab that are open for enrollment."

Answered by AI

Are there other ongoing research projects that are using Tiragolumab?

"There are a total of 1212 studies being run that are investigating tiragolumab. Out of those, 327 are in Phase 3. The majority of tiragolumab clinical trials are based in Shanghai, but there are 68585 different locations worldwide where these studies are taking place."

Answered by AI

How many people are being asked to participate in this clinical trial?

"This study is no longer recruiting patients. The trial was initially posted on February 4th 2020 and the last edit was on September 29th 2022. There are presently 1606 clinical trials actively enrolling patients with small cell lung carcinoma and 1212 trials for Tiragolumab actively looking for participants."

Answered by AI

Who else is applying?

What site did they apply to?
Florida Cancer Specialists; SCRI; Florida Cancer Specialists - Sarasota (Golf St)
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Patients With Untreated Extensive-Stage Small Cell Lung Cancer
2020. "A Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Patients With Untreated Extensive-Stage Small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04256421.
All > Small Cell Lung Cancer
~93 spots leftby May 2025
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