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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 (STAR-121)

Zimberelimab and domvanalimab in combination with chemotherapy versus pembrolizumab with chemotherapy in patients with untreated metastatic non-small cell lung cancer (STAR-121)

Ali Nasermoaddeli

Taiho Pharmaceutical Co., Ltd.

1-27 Kandanishiki-cho, Chiyoda-ku, Tokyo

t-aikawa@taiho.co.jp

Aikawa Tokiko

Taiho Pharmaceutical Co., Ltd.

1-27 Kandanishiki-cho, Chiyoda-ku, Tokyo

+81-3-3293-2113

t-aikawa@taiho.co.jp

Not Recruiting

Jan. 01, 2024

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

- 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 known genomic alterations in ROS proto-oncogene 1 (ROS1), neurotrophic tyrosine receptor kinase (NTRK), proto-oncogene B-raf (BRAF), RET mutations, or other actionable driver oncogenes with approved therapies (actionable genomic alteration).
- Have not received prior systemic treatment for metastatic NSCLC.
- Measurable disease by CT or MRI as 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

- Have mixed small-cell lung cancer 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 (ie, 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

Both

Non-small Cell Lung Cancer

- 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.

- Active Comparator: Pembrolizumab + Chemotherapy
Participants will receive Pembrolizumab 200 mg (up to 35 doses) with chemotherapy Q3W on Day 1 of each 21-day cycle.

- 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/m2 or carboplatin area under the concentration versus time curve (AUC)5 + pemetrexed 500 mg/m2 Q3W for first 4 cycles. After the completion of the first 4 cycles, participants with nonsquamous histology may continue with maintenance pemetrexed 500 mg/m2 Q3W until disease progression or intolerable toxicities.
- Participants with squamous histology will receive carboplatin AUC 6 Q3W with paclitaxel 200 mg/m2 Q3W or nab-paclitaxel 100 mg/m2 weekly (QW) for first 4 cycles.

Overall Survival (OS) in Participants With Positive Programmed Cell Death-Ligand 1 (PD-L1) Expression (>=1%Tumor Cells) and in all Randomized Participants.

+81-89-999-1172

Sept. 12, 2023

No

Argentina/Austria/Belgium/Brazil/Canada/Chile/Germany/Hong Kong/Israel/Italy/Netherlands/Portugal/Singapore/Spain/Taiwan/Turkey/United States/China/France/Korea/Mexico/United Kingdom