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Chemotherapy
Immunotherapy + Chemotherapy for Non-Small Cell Lung Cancer (STAR-121 Trial)
Phase 3
Recruiting
Research Sponsored by Gilead Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pathologically documented NSCLC with documented evidence of Stage IV disease at the time of enrollment
Not received prior systemic treatment for metastatic NSCLC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 58 months
Awards & highlights
STAR-121 Trial Summary
This trial compares 3 treatments for metastatic non-small cell lung cancer to see how they affect progression-free and overall survival.
Who is the study for?
This trial is for adults with untreated metastatic non-small cell lung cancer without certain genetic mutations. Participants should have a good performance status, no prior treatments targeting immune checkpoints, and no history of severe lung conditions or active autoimmune diseases. Pregnant or breastfeeding individuals are excluded.Check my eligibility
What is being tested?
The study compares the effectiveness of two immunotherapy drugs (Zimberelimab and Domvanalimab) combined with chemotherapy against Pembrolizumab with chemotherapy in extending life and delaying cancer progression in patients.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system attacking normal organs, infusion-related reactions, fatigue, nausea, blood count changes, increased risk of infections and potential allergic responses to drug components.
STAR-121 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer is at stage IV.
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I haven't had systemic treatment for advanced lung cancer.
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I am fully active or can carry out light work.
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My tests for EGFR and ALK mutations are negative.
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My cancer does not have genetic changes treatable by specific drugs.
STAR-121 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 58 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 58 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival (OS)
Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Secondary outcome measures
Duration of Response (DOR) as Assessed by BICR per RECIST Version 1.1
Objective Response Rate (ORR) as Assessed by BICR per RECIST Version 1.1
Percentage of Participants Experiencing Clinical Laboratory Abnormalities
+2 moreSTAR-121 Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Zimberelimab (ZIM) +Domvanalimab (DOM) + ChemotherapyExperimental Treatment7 Interventions
Participants will receive ZIM 360 mg + DOM 1200 mg (up to 35 doses) with chemotherapy every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Choice of chemotherapy is dependent on histology.
Participants with nonsquamous histology will receive cisplatin 75 mg/m^2 or carboplatin area under the concentration versus time curve (AUC)5 + pemetrexed 500 mg/m^2 Q3W for first 4 cycles. After the completion of the first 4 cycles, participants with nonsquamous histology may continue with maintenance pemetrexed 500 mg/m^2 Q3W until disease progression or intolerable toxicities.
Participants with squamous histology will receive carboplatin AUC 6 Q3W with paclitaxel 200 mg/m^2 Q3W or nab-paclitaxel 100 mg/m^2 weekly (QW) for first 4 cycles.
Group II: Zimberelimab (ZIM) + ChemotherapyExperimental Treatment6 Interventions
Participants will receive ZIM 360 mg (up to 35 doses) with chemotherapy Q3W on Day 1 of each 21-day cycle.
Choice of chemotherapy is dependent on histology.
Participants with nonsquamous histology will receive cisplatin 75 mg/m^2 or carboplatin AUC 5 + pemetrexed 500 mg/m^2 Q3W for first 4 cycles After the completion of the first 4 cycles, participants with nonsquamous histology may continue with maintenance pemetrexed 500 mg/m^2 Q3W until disease progression or intolerable toxicities.
Participants with squamous histology will receive carboplatin AUC 6 Q3W with paclitaxel 200 mg/m^2 Q3W or nab-paclitaxel 100 mg/m^2 weekly (QW) for first 4 cycles.
Group III: Pembrolizumab (PEMBRO) + ChemotherapyActive Control6 Interventions
Participants will receive PEMBRO 200 mg (up to 35 doses) with chemotherapy Q3W on Day 1 of each 21-day cycle.
Choice of chemotherapy is dependent on histology.
Participants with nonsquamous histology will receive cisplatin 75 mg/m^2 or carboplatin AUC 5 + pemetrexed 500 mg/m^2 Q3W for first 4 cycles. After the completion of the first 4 cycles, participants with nonsquamous histology may continue with maintenance pemetrexed 500 mg/m^2 Q3W until disease progression or intolerable toxicities.
Participants with squamous histology will receive carboplatin AUC 6 Q3W with paclitaxel 200 mg/m^2 Q3W or nab-paclitaxel 100 mg/m^2 weekly (QW) for first 4 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zimberelimab
2018
Completed Phase 1
~50
Carboplatin
2014
Completed Phase 3
~6670
Cisplatin
2013
Completed Phase 3
~1940
Paclitaxel
2011
Completed Phase 4
~5380
Nab-paclitaxel
2014
Completed Phase 3
~2030
Pemetrexed
2014
Completed Phase 3
~5250
Find a Location
Who is running the clinical trial?
Gilead SciencesLead Sponsor
1,084 Previous Clinical Trials
847,759 Total Patients Enrolled
Arcus Biosciences, Inc.Industry Sponsor
41 Previous Clinical Trials
5,346 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
343 Previous Clinical Trials
185,973 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are expected to live for at least 3 more months.I have not received a live-virus vaccine in the last 30 days.My lung cancer is at stage IV.I have or had lung inflammation that needed steroids.My organs are working well.I have received a transplant from another person.I have an active hepatitis B or C infection.I have not had another type of cancer in the last 3 years.I have significant fluid buildup in my body.My lung cancer is a mix of small cell and non-small cell types.I have been treated with drugs targeting the immune system.I haven't had systemic treatment for advanced lung cancer.I am fully active or can carry out light work.I have not had inflammatory bowel disease or a gut perforation in the last 6 months.I have brain metastases or carcinomatous meningitis that haven't been treated.My tests for EGFR and ALK mutations are negative.I am on long-term steroid medication.I have been treated for an autoimmune disease in the last 2 years.My cancer does not have genetic changes treatable by specific drugs.You have a disease that can be measured according to specific guidelines.
Research Study Groups:
This trial has the following groups:- Group 1: Zimberelimab (ZIM) +Domvanalimab (DOM) + Chemotherapy
- Group 2: Pembrolizumab (PEMBRO) + Chemotherapy
- Group 3: Zimberelimab (ZIM) + Chemotherapy
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Has the FDA cleared Zimberelimab (ZIM) +Domvanalimab (DOM) + Chemotherapy for use?
"Zimberelimab (ZIM) +Domvanalimab (DOM) + Chemotherapy is being evaluated in a Phase 3 clinical trial, which means that while there is some evidence of efficacy, safety has been supported by multiple rounds of data collection."
Answered by AI
How many people fit the bill to qualify for this experiment?
"In order to complete this study, the sponsor Gilead Sciences needs to recruit 720 patients from 2 locations in America: Peachtree Hematology Oncology Consultants (Atlanta, Georgia) and Eastern CT Hematology and Oncology Associates (Norwich, Connecticut)."
Answered by AI
Who else is applying?
What site did they apply to?
Palo Verde Hematology Oncology Ltd
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
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