1 Study Matches
PSCI 21-064: A Phase 3, Randomized, Double-Blind Study of BGB-A1217, an Anti-TIGIT Antibody, in Combination With Tislelizumab Compared to Pembrolizumab in Patients With Previously Untreated, PD-L1-Selected, and Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer.
A study designed to evaluate the efficacy and safety of BGB-A1217 + tislelizumab compared with that of pembrolizumab in patients with PD-L1-selected NSCLC who have locally advanced or recurrent disease that is unresectable or not amenable to radiotherapy, with or without chemoradiotherapy, or previously untreated metastatic disease, and whose tumors do not harbor EGFR-sensitizing mutations or ALK translocations. The efficacy and safety of tislelizumab alone will be explored in a small cohort of the same patient population.
18 year(s) or older
Inclusion Criteria:No prior systemic treatment for metastatic NSCLC.
Age ≥ 18 years on the day of signing the informed consent form
Histologically or cytologically documented locally advanced or recurrent NSCLC that is not eligible for curative surgery and/or definitive radiotherapy with or without chemoradiotherapy, or metastatic nonsquamous or squamous NSCLC.
ECOG Performance Status ≤ 1.
At least 1 measurable lesion as defined per RECIST v1.1.
Exclusion Criteria:Known sensitizing mutation in the EGFR gene or an ALK fusion oncogene.
Active autoimmune diseases or history of autoimmune diseases that may relapse.
Active leptomeningeal disease or uncontrolled, untreated brain metastasis
Patients with active hepatitis C.
Known history of HIV infection.
Lung Disease & Asthma