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Monoclonal Antibodies
Tiragolumab + Atezolizumab + Chemo for Non-Small Cell Lung Cancer (SKYSCRAPER-06 Trial)
Phase 2 & 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
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Known tumor programmed death-ligand 1 (PD-L1) status
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 5 years (phase 2); up to approximately 7 years (phase 3)
Awards & highlights
SKYSCRAPER-06 Trial Summary
This trial will compare the efficacy, safety, and pharmacokinetics of tiragolumab in combination with atezolizumab and pemetrexed compared with placebo in combination with pembrolizumab and pemetrexed in participants with previously untreated, locally advanced unresectable or metastatic NSCLC.
Who is the study for?
This trial is for adults with advanced non-squamous NSCLC who haven't had treatment for metastatic lung cancer. They should have measurable disease, a life expectancy of at least 12 weeks, good performance status (able to carry out daily activities), and proper organ function. Excluded are those with certain gene mutations, active infections or pneumonitis, recent immunotherapy or systemic treatments, autoimmune diseases, untreated brain metastases, pregnancy or breastfeeding.Check my eligibility
What is being tested?
The study compares the effectiveness and safety of two drug combinations in treating NSCLC: Arm A uses Tiragolumab with Atezolizumab plus chemotherapy drugs Pemetrexed and Carboplatin/Cisplatin; Arm B uses a placebo with Pembrolizumab plus the same chemo drugs. Participants will be randomly assigned to one of these arms.See study design
What are the potential side effects?
Possible side effects include immune-related reactions like inflammation in various organs (lungs, liver), infusion reactions from the drug administration process itself, fatigue from treatment burden on the body's energy resources, potential blood disorders due to bone marrow suppression by chemotherapy agents.
SKYSCRAPER-06 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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I know my cancer's PD-L1 status.
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I haven't received any systemic treatment for my advanced non-squamous NSCLC.
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My advanced lung cancer cannot be removed by surgery or cured with radiation and chemotherapy.
SKYSCRAPER-06 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 5 years (phase 2); up to approximately 7 years (phase 3)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 5 years (phase 2); up to approximately 7 years (phase 3)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Investigator-Assessed Confirmed Objective Response Rate (ORR) (Phase 2)
Investigator-Assessed Progression-Free Survival (PFS) (Phase 2 and Phase 3)
Overall Survival (Phase 3)
Secondary outcome measures
Investigator-Assessed Confirmed ORR (Phase 3)
Investigator-Assessed Duration of Response (DOR) (Phase 2 and Phase 3)
Investigator-Assessed PFS at 6 Months and 12 Months (Phase 3)
+13 moreSKYSCRAPER-06 Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Tiragolumab+Atezolizumab+Pemetrexed+Carboplatin or CisplatinExperimental Treatment5 Interventions
Induction treatment with tiragolumab in combination with atezolizumab plus pemetrexed and cisplatin or carboplatin will be administered to participants on Day 1 of each 21-day cycle for 4 cycles. Following the induction phase, participants will continue maintenance therapy with tiragolumab in combination with atezolizumab and pemetrexed on Day 1 of each 21-day cycle.
Group II: Placebo+Pembrolizumab+Pemetrexed+Carboplatin or CisplatinPlacebo Group5 Interventions
Induction treatment with placebo in combination with pembrolizumab plus pemetrexed and cisplatin or carboplatin will be administered to participants on Day 1 of each 21-day cycle for 4 cycles. Following the induction phase, participants will continue maintenance therapy with placebo in combination with pembrolizumab and pemetrexed on Day 1 of each 21-day cycle.
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
Pemetrexed
2014
Completed Phase 3
~5250
Carboplatin
2014
Completed Phase 3
~6670
Cisplatin
2013
Completed Phase 3
~1940
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,088,512 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,199 Previous Clinical Trials
887,960 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have tested negative for HIV.I have or had an autoimmune disease or immune deficiency.I haven't taken any immune-weakening drugs in the last 2 weeks and don't expect to need any during the study.I am fully active or can carry out light work.I haven't had cancer other than NSCLC in the last 5 years, except for very low-risk types.I haven't had a severe infection in the last 4 weeks.I am not allergic to any of the chemotherapy drugs I might receive.My lung cancer is of a specific type called pulmonary lymphoepithelioma-like carcinoma.I have previously been treated with specific immune therapies.You do not have an active hepatitis B or C virus in your blood.I haven't taken any immune-boosting drugs in the last 4 weeks or longer.You have a tumor that can be measured using specific guidelines for evaluating solid tumors.I have a history of certain lung conditions or currently have lung inflammation.My cancer has EGFR mutations or ALK gene changes.I know my cancer's PD-L1 status.I haven't received any systemic treatment for my advanced non-squamous NSCLC.You are expected to live for at least 12 more weeks.I am not pregnant or breastfeeding.I have brain metastases that are untreated or getting worse.My cancer has a specific genetic change in ROS1 or BRAFV600E.My advanced lung cancer cannot be removed by surgery or cured with radiation and chemotherapy.My blood and organs are functioning well.
Research Study Groups:
This trial has the following groups:- Group 1: Tiragolumab+Atezolizumab+Pemetrexed+Carboplatin or Cisplatin
- Group 2: Placebo+Pembrolizumab+Pemetrexed+Carboplatin or Cisplatin
Awards:
This trial has 0 awards, including: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.
For what indications is Tiragolumab typically prescribed?
"Tiragolumab is an effective treatment for refractory, relapsed mediastinal large b-cell lymphoma as well as other conditions like initial treatment, small cell lung cancer (sclc), and advanced testicular cancer."
Answered by AI
Are there any open vacancies for participants in this clinical trial?
"The study, which is detailed on clinicaltrials.gov, is still looking for participants. December 14th 2020 was when the study was first made public and the most recent update was on November 3rd, 2022."
Answered by AI
Has Tiragolumab been studied in any other scientific research trials?
"Tiragolumab was first researched over two decades ago in 1997. As of now, there have been 2045 completed trials and 2316 trials are currently underway. A notable amount of these ongoing trials are taking place in Knoxville, Tennessee."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
Kaiser Permanente - Vallejo
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
2
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