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Atezolizumab + Tiragolumab for Lung Cancer (SKYSCRAPER-03 Trial)
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.
SKYSCRAPER-03 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSKYSCRAPER-03 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 3 trial • 1225 Patients • NCT02008227SKYSCRAPER-03 Trial Design
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- You are expected to live for at least 12 weeks.My lung cancer is at an advanced stage and cannot be removed by surgery.I am taking medication that weakens my immune system.I will not donate sperm during and for 3 months after treatment.I have been newly diagnosed with Stage III lung cancer that cannot be surgically removed.My NSCLC has an EGFR mutation or ALK fusion.My radiotherapy was 54-66 Gy using advanced techniques.I have previously been treated with specific immune therapies.My cancer has spread to distant parts of my body.I will not have unprotected sex for 90 days after my last dose of the medication.I am fully active or can carry out light work.I had a PET-CT scan within the last 42 days before starting chemoradiotherapy.My cancer did not worsen during or after platinum-based chemo and radiation therapy.My advanced lung cancer worsened after my last major treatment.I have no major side effects from previous cancer treatments.I have had severe lung inflammation from previous cancer treatments.I have had a previous transplant of stem cells or an organ.I have an active Epstein-Barr virus infection.I am not pregnant or breastfeeding.I've had severe or ongoing mild side effects from past immunotherapy.My blood and organs are functioning well.I know my PD-L1 status.I have a history of lung inflammation not caused by infections.I am receiving a specific treatment sequence for advanced lung cancer.I have had cancer other than lung cancer in the last 5 years, but it was not likely to spread or be fatal.You currently have or have had a condition where your immune system attacks your own body, or your immune system does not work properly.I've completed at least two cycles of chemotherapy with radiation within the last 42 days.
- Group 1: Atezolizumab + Tiragolumab
- Group 2: Durvalumab
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
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."
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."
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."
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."
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."
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."
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."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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