A Study of Tislelizumab in Combination With Investigational Agents in Participants With Non-Small Cell Lung Cancer
- 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%).
- Short title
- A Study of Tislelizumab in Combination With Investigational Agents in Participants With Non-Small Cell Lung Cancer
- Official title
- 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
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Active, not recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2026-10-01
- First posted
- 2022-12-02
- Registry last updated
- 2026-04-15
- Primary completion date
- 2025-12-31
- Start date
- 2023-03-07
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- BeiGene
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05635708
- ClinicalTrials.gov ID
- NCT05635708
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- No masking
Confirmed overall response rate (ORR)
Timeframe: Up to 6 months
ORR is defined as the percentage of participants with partial or complete response, as assessed by the investigator using the Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1
Progression-free survival (PFS)
Timeframe: Up to 1 year
PFS is defined as the time from date of randomization, or the first dose for safety lead-in participants , until first documentation of progression or death, whichever comes first, as assessed by the investigator using RECIST v1.
Duration of Response (DOR)
Timeframe: Up to 1 year
DOR is defined as the time from the first determination of a confirmed response per RECIST v1.1 until the first documentation of progression or death, whichever comes first as assessed by the investigator
Clinical Benefit Rate (CBR)
Timeframe: Up to 6 months
CBR is defined as the percentage of participants with a best overall response of a complete response, partial response, or durable stable disease, as assessed by the investigator using RECIST v1.1
Disease Control Rate (DCR)
Timeframe: Up to 6 months
DCR is defined as the percentage of participants with a best overall response of complete response, partial response, or stable disease, as assessed by the investigator using RECIST v1.1
Number of participants with adverse events (AEs)
Timeframe: From the first dose of study drug(s) to 90 days after initiation of new anticancer therapy, death, withdrawal of consent, or loss to follow-up, whichever occurs first, up to approximately 2 years
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including laboratory values, vital signs, physical examination findings, and electrocardiogram results.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
Key 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.
Key Exclusion Criteria:
-
Diagnosis of mixed small cell lung cancer.
-
Known genomic alterations for which effective targeted therapies are available according to local standard of care, including but not limited to:
- Epidermal growth factor receptor (EGFR) mutations
- Anaplastic lymphoma kinase (ALK) rearrangements
- B-Raf proto-oncogene (BRAF) mutations
- Rearranged during transfection (RET) fusions
- c-ros oncogene 1 (ROS1) rearrangements
-
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:
- PD-1 (programmed cell death protein 1) inhibitors
- PD-L1 (programmed death-ligand 1) inhibitors
- PD-L2 (programmed death-ligand 2) inhibitors
- TIGIT (T cell immunoreceptor with Ig and ITIM domains) inhibitors
- LAG-3 (lymphocyte activation gene 3) inhibitors
-
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.
Note: Additional protocol-defined and sub-study-specific criteria may apply.
- Valkyrie Clinical TrialsLos Angeles, United States
- Massachusetts General HospitalBoston, United States
- Memorial Sloan Kettering Cancer Center MskccNew York, United States
- Providence Portland Medical CenterPortland, United States
- The University of Texas Md Anderson Cancer CenterHouston, United States
- Blacktown Cancer and Haematology CentreBlacktown, Australia
- Chris Obrien LifehouseCamperdown, Australia
- Northern Beaches HospitalFrenchs Forest, Australia
- Port Macquarie Base HospitalPort Macquarie, Australia
- One Clinical ResearchNedlands, Australia
- St John of God Health CareSubiaco, Australia
- Hospital de Amor BarretosBarretos, Brazil
- Hospital Do Cancer de LondrinaLondrina, Brazil
- Centro Gaucho Integrado de Oncologia Hospital Mae de DeusPorto Alegre, Brazil
- Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio PretoSão José do Rio Preto, Brazil
- Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de OliveiraSão Paulo, Brazil
- Cross Cancer InstituteEdmonton, Canada
- The Second Hospital of Anhui Medical UniversityHefei, China
- The Fifth Medical Center of Chinese Pla General HospitalBeijing, China
- Fujian Cancer HospitalFuzhou, China
- Affiliated Hospital of Hebei UniversityBaoding, China
- Harbin Medical University Cancer HospitalHarbin, China
- Henan Cancer HospitalZhengzhou, China
- Hubei Cancer HospitalWuhan, China
- Nantong Tumor Hospital Branch NorthNantong, China
And 36 more, listed on the interactive page.
- 2022-502738-18-00
- CTR20230892
Related records
Drugs (6)
Lead sponsors (1)
Conditions (1)
- Non-small cell lung carcinoma Primary condition