Mass General - Division of Clinical Research

A Study of Tislelizumab in Combination With Investigational Agents in Participants With Non-Small Cell Lung Cancer

Purpose

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%).

Conditions

Non-small Cell Lung Cancer
Metastatic Non-small Cell Lung Cancer

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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. 2. 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. 3. 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. 4. At least 1 measurable lesion as defined per RECIST v1.1. 5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

Exclusion Criteria

Has mixed small cell lung cancer. 2. Participants with known actionable mutations (including but not limited to EGFR, ALK, BRAF, RET, and ROSI mutations) for which a targeted therapy is available per local standard of care. 3. 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. 4. Has received any Chinese herbal medicine or Chinese patent medicines used to control cancer ≤ 14 days before randomization/enrollment. 5. Active leptomeningeal disease or uncontrolled, untreated brain metastasis, or active autoimmune diseases. NOTE: Other protocol and sub-study protocol defined criteria may apply

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Sub-study 1: Experimental Arm 1A	Tislelizumab + BGB-A445	Drug: Tislelizumab Administered by intravenous infusion Drug: BGB-A445 Administered by intravenous infusion
Experimental Sub-study 1: Experimental Arm 2A	Tislelizumab + LBL-007	Drug: Tislelizumab Administered by intravenous infusion Drug: LBL-007 Administered by intravenous infusion
Experimental Sub-study 1: Experimental Arm 3A	Tislelizumab + BGB-15025	Drug: Tislelizumab Administered by intravenous infusion Drug: BGB-15025 Administered Orally
Experimental Sub-study 1: Reference Arm Tislelizumab alone	Tislelizumab alone	Drug: Tislelizumab Administered by intravenous infusion
Experimental Sub-study 2: Experimental Arm 1B	Tislelizumab + investigator's choice of histology-appropriate chemotherapy + BGB-A445	Drug: Tislelizumab Administered by intravenous infusion Drug: BGB-A445 Administered by intravenous infusion Drug: Carboplatin Investigator's choice; administered by intravenous infusion Drug: Cisplatin Investigator's choice; administered by intravenous infusion Drug: pemetrexed Investigator's choice; administered by intravenous infusion Drug: Paclitaxel Investigator's choice; administered by intravenous infusion Drug: Nab paclitaxel Investigator's choice; administered by intravenous infusion
Experimental Sub-study 2: Experimental Arm 2B	Tislelizumab + investigator's choice of histology-appropriate chemotherapy + LBL-007	Drug: Tislelizumab Administered by intravenous infusion Drug: LBL-007 Administered by intravenous infusion Drug: Carboplatin Investigator's choice; administered by intravenous infusion Drug: Cisplatin Investigator's choice; administered by intravenous infusion Drug: pemetrexed Investigator's choice; administered by intravenous infusion Drug: Paclitaxel Investigator's choice; administered by intravenous infusion Drug: Nab paclitaxel Investigator's choice; administered by intravenous infusion
Experimental Sub-study 2: Experimental Arm 3B	Tislelizumab + investigator's choice of histology-appropriate chemotherapy + BGB-15025	Drug: Tislelizumab Administered by intravenous infusion Drug: Carboplatin Investigator's choice; administered by intravenous infusion Drug: Cisplatin Investigator's choice; administered by intravenous infusion Drug: pemetrexed Investigator's choice; administered by intravenous infusion Drug: Paclitaxel Investigator's choice; administered by intravenous infusion Drug: Nab paclitaxel Investigator's choice; administered by intravenous infusion Drug: BGB-15025 Administered Orally
Active Comparator Sub-study 2: Reference Arm	Tislelizumab + investigator's choice of histology-appropriate chemotherapy	Drug: Tislelizumab Administered by intravenous infusion Drug: Carboplatin Investigator's choice; administered by intravenous infusion Drug: Cisplatin Investigator's choice; administered by intravenous infusion Drug: pemetrexed Investigator's choice; administered by intravenous infusion Drug: Paclitaxel Investigator's choice; administered by intravenous infusion Drug: Nab paclitaxel Investigator's choice; administered by intravenous infusion

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114

More Details

Status: Recruiting
Sponsor: BeiGene

Study Contact

BeiGene
+1-877-828-5568
clinicaltrials@beigene.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.