Studieoverzicht

Study name: STAR-121 (Gilead GS-US-626-6216)

Histology NSCLC
Tumor stage Stage IV
Host / recruiting sites UMC Groningen, Erasmus MC
Enrollment Closed
Therapy line First line (1L)
Design

this is a Phase 3, global, multicenter, randomized, open-label, controlled study
to compare the efficacy and safety of DOM+ ZIM in combination with chemotherapy relative
to PEMBRO in combination with chemotherapy in participants with metastatic non–small cell
lung cancer (NSCLC) with no epidermal growth factor receptor (EGFR) or anaplastic
lymphoma kinase (ALK) genomic tumor aberrations who have not received previous systemic
therapy for metastatic disease.

Intervention

domvanalimab (DOM) +
zimberelimab (ZIM) in combination with chemotherapy
relative to pembrolizumab (PEMBRO) in combination with
chemotherapy (Group A versus Group B)

Key inclusion criteria
  1. Participants assigned male at birth and participants assigned female at birth, 18 years of
    age or older, able to understand and give written informed consent.
  2. Life expectancy ≥ 3 months.
  3. Pathologically documented NSCLC that meets both criteria below:
    a) Have documented evidence of Stage IV NSCLC disease at the time of enrollment
    (based on AJCC, Eighth Edition).
    b) Have documented negative test results for EGFR and ALK mutations.
    Note: tumor testing for EGFR or ALK mutations is required for participants with
    nonsquamous NSCLC tumor histology if status is unknown (Section 6.3.9).
  4. Have no actionable genomic alterations such as ROS proto-oncogene 1, neurotrophic
    tyrosine receptor kinase, proto-oncogene B-raf, RET mutations, or other driver oncogenes
    with approved frontline therapies. Testing of actionable genomic alterations required by
    local regulations will be performed locally.
  5. Provide adequate tumor tissue from locations not radiated prior to biopsy to evaluate
    PD-L1 expression prior to randomization. Bone biopsies, cytology, and fine needle
    aspirates are not suitable tissues. If no tissue is available, a new biopsy will need to be
    obtained prior to enrollment in the study.
  6. Have not received prior systemic treatment for metastatic NSCLC. Participants who
    received chemotherapy for nonmetastatic disease are eligible if the treatment was
    completed at least 12 months prior to the start of study treatment.
  7. Measurable disease per RECIST v1.1 criteria by investigator assessment (Appendix 7).
    Tumor lesions situated in a previously irradiated area are considered measurable if
    progression has been demonstrated in such lesions.
  8. ECOG performance status score of 0 or 1."
Key exclusion criteria
  1. Have mixed small-cell lung cancer and NSCLC histology.
  2. Positive serum pregnancy test or participants who are breastfeeding or have plans to
    breastfeed during the study period and for the required duration of contraception use after
    the last dose of study drug.
  3. Received prior treatment with any anti-programmed cell death protein 1, anti-PD-L1, or
    any other antibody targeting an immune checkpoint. Participants who received
    programmed cell death protein 1/programmed cell death ligand 1 inhibitors as a part of
    treatment for early stage or locally advanced NSCLC are not eligible.
  4. Known hypersensitivity to the study drug, its metabolites, or formulation excipient."
Contact information