A Study of Tislelizumab in Combination With Investigational Agents in Participants With Non-Small… (NCT05635708) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study of Tislelizumab in Combination With Investigational Agents in Participants With Non-Small Cell Lung Cancer
United States400 participantsStarted 2023-03-07
Plain-language summary
The purpose of this study is to assess the antitumor activity, safety, and tolerability of tislelizumab plus investigational agent(s) with or without chemotherapy. This study is structured as a master protocol with separate sub- studies. Sub-study 1 includes participants with non-small cell lung cancer (NSCLC) with high programmed cell death protein ligand-1 (PD-L1) expression (≥ 50%), and Sub-study 2 includes participants with NSCLC with low or negative (PD-L1) expression (\< 50%).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), including nonsquamous or squamous subtypes, that is either locally advanced or recurrent and not eligible for curative surgery and/or definitive chemoradiotherapy, or metastatic NSCLC.
✓. No prior systemic therapy administered as the primary treatment for metastatic NSCLC. Prior adjuvant or neoadjuvant chemotherapy, definitive chemoradiation, or adjuvant radiotherapy for locally advanced disease is permitted, provided the last dose of chemotherapy and/or radiotherapy occurred at least 6 months prior to randomization/enrollment.
✓. Tumor programmed death-ligand 1 (PD-L1) expression must be evaluable, as determined by a local or central laboratory using archival tumor tissue or a fresh biopsy. Participants with unknown PD-L1 expression are not eligible.
✓. At least one measurable lesion, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
. Known genomic alterations for which effective targeted therapies are available according to local standard of care, including but not limited to:
✕. Participants with nonsquamous NSCLC and unknown EGFR mutation status must undergo local testing. Those found to have EGFR-sensitizing mutations will be excluded.
✕. Prior treatment with immune-based therapies that target immune checkpoint pathways, including:
✕. Participants previously treated with these agents in a neoadjuvant, adjuvant, or consolidation setting may be eligible if a treatment-free interval of at least 6 months has elapsed since the last dose and radiologic evidence of recurrence is present.
✕. Use of Chinese herbal medicines or Chinese patent medicines intended for cancer control within 14 days prior to randomization/enrollment.
✕. Presence of active leptomeningeal disease, untreated or uncontrolled brain metastases, or active autoimmune disease.