2022-502738-18-00
Active, not recruiting
Phase 2
MASTER PROTOCOL: A Phase 2, Open-label, Multi-arm Study of Tislelizumab in Combination With Investigational Agents With or Without Chemotherapy in Patients With Previously Untreated, Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer.
Beigene Ltd., Beigene Ltd., Beigene Ltd.9 sites in 4 countries22 target enrollmentStarted: August 22, 2023Last updated:
Overview
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Beigene Ltd., Beigene Ltd., Beigene Ltd.
- Enrollment
- 22
- Locations
- 9
- Primary Endpoint
- Confirmed overall response rate (ORR) as assessed by the investigators per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1
Overview
Brief Summary
To assess the antitumor activity of tislelizumab plus investigational agent(s) with or without chemotherapy.
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Histologically or cytologically confirmed NSCLC (nonsquamous or squamous) that is locally advanced or recurrent and not eligible for curative surgery and/or definitive chemoradiotherapy, or metastatic NSCLC.
- •No prior systemic treatment given as primary therapy for metastatic NSCLC. Prior adjuvant/neoadjuvant chemotherapy or definitive chemoradiation/adjuvant radiotherapy for locally advanced disease is allowed provided the last dose of chemotherapy and/or radiotherapy occurred at least 6 months before randomization/enrollment.
- •Evaluable tumor PD-L1 expression as determined by a local laboratory or by central laboratory on archival tumor tissue or fresh biopsy. Patients with unknown PD-L1 expression will not be eligible for this study.
- •At least 1 measurable lesion as defined per RECIST v1.1
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •NOTE: Other protocol and sub-study protocol defined criteria may apply
Exclusion Criteria
- •Has mixed small cell lung cancer.
- •Patients with known EGFR mutations or actionable mutations with available targeted therapies.
- •Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-TIGIT, anti-LAG-3 or any other antibody or drug targeting T-cell costimulation or immune checkpoint pathways. Note: Patients who received prior neoadjuvant, adjuvant or immuno-oncology therapies targeting PD-1 or PD-L1 in consolidation are eligible, if there has been a treatment-free interval of ≥ 6 months from last dose of immuno-oncology therapy prior to radiologic recurrence of disease.
- •Has received any Chinese herbal medicine or Chinese patent medicines used to control cancer ≤ 14 days before randomization/enrollment.
- •Active leptomeningeal disease or uncontrolled, untreated brain metastasis, or active autoimmune diseases.
- •NOTE: Other protocol and sub-study protocol defined criteria may apply
Outcomes
Primary Outcomes
Confirmed overall response rate (ORR) as assessed by the investigators per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1
Confirmed overall response rate (ORR) as assessed by the investigators per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1
Secondary Outcomes
- Progression-free survival (PFS), duration of response (DOR), clinical benefit rate (CBR), and disease control rate (DCR) as assessed by the investigator per RECIST v1.1.
- The incidence and severity of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events NCI-CTCAE v5.0 in reference arms and experimental arms.
- Plasma or serum concentrations of tislelizumab and investigational agents at specified timepoints.
- Immunogenic responses to tislelizumab and investigational protein therapeutics, evaluated through the detection of antidrug antibodies (ADA).
Investigators
BeiGene Clinical Support
Scientific
Beigene Ltd.
Study Sites (9)
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