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Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung Cancer (STAR-121)

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ClinicalTrials.gov Identifier: NCT05502237
Recruitment Status : Recruiting
First Posted : August 16, 2022
Last Update Posted : April 8, 2024
Sponsor:
Collaborator:
Arcus Biosciences, Inc.
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE August 12, 2022
First Posted Date  ICMJE August 16, 2022
Last Update Posted Date April 8, 2024
Actual Study Start Date  ICMJE October 12, 2022
Estimated Primary Completion Date September 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2022)
  • Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [ Time Frame: Up to 31 months ]
    PFS is defined as the time from the date of randomization until disease progression (PD) or death from any cause, whichever comes first.
  • Overall Survival (OS) [ Time Frame: Up to 58 months ]
    OS is defined as the time from the date of randomization to the date of death from any cause.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2022)
  • Objective Response Rate (ORR) as Assessed by BICR per RECIST Version 1.1 [ Time Frame: Up to 58 Months ]
    ORR is defined as the proportion of participants who have achieved a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks later.
  • Duration of Response (DOR) as Assessed by BICR per RECIST Version 1.1 [ Time Frame: Up to 58 Months ]
    DOR is defined as the time from the first response (CR or PR), to the first documented PD or death from any cause, whichever comes first.
  • Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) [ Time Frame: First dose date up to 58 months plus 30 days ]
  • Percentage of Participants Experiencing Clinical Laboratory Abnormalities [ Time Frame: First dose date up to 58 months plus 30 days ]
  • Time to First Symptom Deterioration in Non-small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) Total Score [ Time Frame: Baseline, Up to 58 Months ]
    The NSCLC-SAQ is a patient reported outcome measure with seven items assessing five symptom concepts of NSCLC: cough, pain, dyspnea, fatigue, and appetite. Each item is rated using a five-point verbal rating scale from "No <symptom> At All" to "Very severe <symptom>" or from "Never to Always," corresponding to a score of 0 to 4. The sum of all 5 domain scores will be computed, if any scores are missing, a total score will not be computed. The total score ranges between 0 and 20 with higher scores indicating more severe symptoms.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung Cancer
Official Title  ICMJE A Randomized, Open-Label, Phase 3 Study to Evaluate Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy for the First-Line Treatment of Patients With Metastatic Non-Small Cell Lung Cancer With No Epidermal Growth Factor Receptor or Anaplastic Lymphoma Kinase Genomic Tumor Aberrations
Brief Summary The primary objective of this study is to compare the effect of zimberelimab (ZIM) and domvanalimab (DOM) in combination with chemotherapy relative to pembrolizumab (PEMBRO) in combination with chemotherapy on progression-free survival (PFS) and overall survival (OS) in patients with untreated metastatic non-small cell lung cancer with no actionable genomic alteration.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-small Cell Lung Cancer
Intervention  ICMJE
  • Drug: Zimberelimab
    Administered intravenously
    Other Names:
    • GS-0122
    • AB122
  • Drug: Domvanalimab
    Administered intravenously
    Other Names:
    • GS-0154
    • AB154
  • Drug: Pembrolizumab
    Administered intravenously
    Other Name: KEYTRUDA®
  • Drug: Carboplatin
    Administered intravenously
  • Drug: Cisplatin
    Administered intravenously
  • Drug: Paclitaxel
    Administered intravenously
  • Drug: Nab-paclitaxel
    Administered intravenously
  • Drug: Pemetrexed
    Administered intravenously
Study Arms  ICMJE
  • Experimental: Zimberelimab (ZIM) +Domvanalimab (DOM) + Chemotherapy

    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.
    Interventions:
    • Drug: Zimberelimab
    • Drug: Domvanalimab
    • Drug: Carboplatin
    • Drug: Cisplatin
    • Drug: Paclitaxel
    • Drug: Nab-paclitaxel
    • Drug: Pemetrexed
  • Active Comparator: Pembrolizumab (PEMBRO) + Chemotherapy

    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.
    Interventions:
    • Drug: Pembrolizumab
    • Drug: Carboplatin
    • Drug: Cisplatin
    • Drug: Paclitaxel
    • Drug: Nab-paclitaxel
    • Drug: Pemetrexed
  • Experimental: Zimberelimab (ZIM) + Chemotherapy

    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.
    Interventions:
    • Drug: Zimberelimab
    • Drug: Carboplatin
    • Drug: Cisplatin
    • Drug: Paclitaxel
    • Drug: Nab-paclitaxel
    • Drug: Pemetrexed
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 12, 2022)
720
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2027
Estimated Primary Completion Date September 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Life expectancy ≥ 3 months.
  • Pathologically documented NSCLC that meets both of the criteria below:

    • Have documented evidence of Stage IV NSCLC disease at the time of enrollment (based on American Joint Committee on Cancer (AJCC), Eighth Edition).
    • Have documented negative test results for epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) mutations.
  • Have no actionable genomic alterations such as ROS proto-oncogene 1 (ROS1), neurotrophic tyrosine receptor kinase (NTRK), proto-oncogene B-raf (BRAF), RET mutations, or other driver oncogenes with approved frontline therapies.
  • Have not received prior systemic treatment for metastatic NSCLC.
  • Measurable disease per RECIST v1.1 criteria by investigator assessment.
  • Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.
  • Have adequate organ functions.

Key Exclusion Criteria:

  • Have mixed small-cell lung cancer (SCLC) and NSCLC histology.
  • Positive serum pregnancy test or individuals who are breastfeeding or have plans to breastfeed during the study period.
  • Received prior treatment with any anti-PD-1, anti-PD-L1, or any other antibody targeting an immune checkpoint.
  • Known hypersensitivity to the study drug, its metabolites, or formulation excipient.
  • Have an active second malignancy or have had an active second malignancy within 3 years prior to enrollment.
  • Have an active autoimmune disease that required systemic treatment in past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs).
  • Are receiving chronic systemic steroids.
  • Have significant third-space fluid retention.
  • Have untreated central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or gastrointestinal perforation within 6 months of enrollment.
  • Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
  • Has had an allogenic tissue/solid organ transplant.
  • Have received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu and COVID-19 vaccines that do not contain live virus are permitted.
  • Have known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gilead Clinical Study Information Center 1-833-445-3230 (GILEAD-0) GileadClinicalTrials@gilead.com
Listed Location Countries  ICMJE Argentina,   Austria,   Belgium,   Brazil,   Canada,   Chile,   China,   France,   Germany,   Hong Kong,   Israel,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   Portugal,   Singapore,   Spain,   Taiwan,   Turkey,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05502237
Other Study ID Numbers  ICMJE GS-US-626-6216
2022-000578-25 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Gilead Sciences
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Gilead Sciences
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Arcus Biosciences, Inc.
Investigators  ICMJE
Study Director: Gilead Study Director Gilead Sciences
PRS Account Gilead Sciences
Verification Date April 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP