Efficacy, Safety, and Pharmacodynamics of Tislelizumab Monotherapy and Multiple Tislelizumab-based Immunotherapy Combinations in Participants With Resectable Non-Small Cell Lung Cancer
- Conditions
- Non Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT05577702
- Lead Sponsor
- BeiGene
- Brief Summary
This is a randomized, open-label, multicenter, Phase 2, umbrella study to evaluate the preliminary efficacy, safety, and pharmacodynamics of tislelizumab as monotherapy and in combination with investigational agents as neoadjuvant treatment in Chinese participants with resectable Stage II to IIIA non-small cell lung cancer (NSCLC). The study is designed with the flexibility of adding treatment arms as new treatments become available or discontinuing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, and of modifying the participant population.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 121
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
- Histologically confirmed Stage II-IIIA NSCLC (per the Eighth American Joint Committee on Cancer/Union Internationale Contre le Cancer [NSCLC] staging system)
- Evaluation by an attending thoracic surgeon to confirm eligibility for an R0 resection with curative intent
- Adequate hematologic and organ function, defined by protocol-specified laboratory test results, obtained ≤ 7 days before randomization
- Provide formalin-fixed paraffin-embedded block (preferred) or at least 15 freshly cut unstained FFPE slides of the primary tumor for biomarker evaluation during screening
- Any prior antineoplastic therapy(ies) for current lung cancer (eg, radiotherapy, targeted therapies, ablation, or other systemic or local antineoplastic treatment)
- Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, anti-cell immunoglobulin and ITIM domain (TIGIT), anti-lymphocyte activation gene-3 (LAG-3), or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways
- Has mixed small cell lung cancer
- Participants with large cell neuroendocrine carcinoma (LCNEC)
- The presence of locally advanced unresectable NSCLC regardless of stage or metastatic disease
- Known EGFR sensitizing mutations and/or ALK rearrangement
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1B: Tislelizumab and Ociperlimab Ociperlimab Tislelizumab + ociperlimab on a 3-week cycle for 2 to 4 cycles, followed by surgical resection (each cycle is 21 days) Arm 1C: Tislelizumab and LBL-007 LBL-007 Tislelizumab + LBL-007 on a 3-week cycle for 2 to 4 cycles, followed by surgical resection (each cycle is 21 days) Arm 2C: LBL-007 and Tislelizumab and Chemotherapy LBL-007 LBL-007 + tislelizumab + chemotherapy on a 3-week cycle for 2 to 4 cycles, followed by surgical resection (each cycle is 21 days); Platinum-based doublet chemotherapy options may include: * Cisplatin/carboplatin + pemetrexed (nonsquamous) * Cisplatin/carboplatin + paclitaxel (squamous) Arm 1A: Tislelizumab Monotherapy Tislelizumab Tislelizumab on a 3-week cycle for 2 to 4 cycles, followed by surgical resection (each cycle is 21 days) Arm 1B: Tislelizumab and Ociperlimab Tislelizumab Tislelizumab + ociperlimab on a 3-week cycle for 2 to 4 cycles, followed by surgical resection (each cycle is 21 days) Arm 2A: Tislelizumab and Chemotherapy Cisplatin Tislelizumab + chemotherapy on a 3-week cycle for 2 to 4 cycles, followed by surgical resection (each cycle is 21 days); Platinum-based doublet chemotherapy options may include: * Cisplatin/carboplatin + pemetrexed (nonsquamous) * Cisplatin/carboplatin + paclitaxel (squamous) Arm 1C: Tislelizumab and LBL-007 Tislelizumab Tislelizumab + LBL-007 on a 3-week cycle for 2 to 4 cycles, followed by surgical resection (each cycle is 21 days) Arm 2A: Tislelizumab and Chemotherapy Pemetrexed Tislelizumab + chemotherapy on a 3-week cycle for 2 to 4 cycles, followed by surgical resection (each cycle is 21 days); Platinum-based doublet chemotherapy options may include: * Cisplatin/carboplatin + pemetrexed (nonsquamous) * Cisplatin/carboplatin + paclitaxel (squamous) Arm 2A: Tislelizumab and Chemotherapy Tislelizumab Tislelizumab + chemotherapy on a 3-week cycle for 2 to 4 cycles, followed by surgical resection (each cycle is 21 days); Platinum-based doublet chemotherapy options may include: * Cisplatin/carboplatin + pemetrexed (nonsquamous) * Cisplatin/carboplatin + paclitaxel (squamous) Arm 2A: Tislelizumab and Chemotherapy Carboplatin Tislelizumab + chemotherapy on a 3-week cycle for 2 to 4 cycles, followed by surgical resection (each cycle is 21 days); Platinum-based doublet chemotherapy options may include: * Cisplatin/carboplatin + pemetrexed (nonsquamous) * Cisplatin/carboplatin + paclitaxel (squamous) Arm 2C: LBL-007 and Tislelizumab and Chemotherapy Pemetrexed LBL-007 + tislelizumab + chemotherapy on a 3-week cycle for 2 to 4 cycles, followed by surgical resection (each cycle is 21 days); Platinum-based doublet chemotherapy options may include: * Cisplatin/carboplatin + pemetrexed (nonsquamous) * Cisplatin/carboplatin + paclitaxel (squamous) Arm 2A: Tislelizumab and Chemotherapy Paclitaxel Tislelizumab + chemotherapy on a 3-week cycle for 2 to 4 cycles, followed by surgical resection (each cycle is 21 days); Platinum-based doublet chemotherapy options may include: * Cisplatin/carboplatin + pemetrexed (nonsquamous) * Cisplatin/carboplatin + paclitaxel (squamous) Arm 2C: LBL-007 and Tislelizumab and Chemotherapy Tislelizumab LBL-007 + tislelizumab + chemotherapy on a 3-week cycle for 2 to 4 cycles, followed by surgical resection (each cycle is 21 days); Platinum-based doublet chemotherapy options may include: * Cisplatin/carboplatin + pemetrexed (nonsquamous) * Cisplatin/carboplatin + paclitaxel (squamous) Arm 2C: LBL-007 and Tislelizumab and Chemotherapy Cisplatin LBL-007 + tislelizumab + chemotherapy on a 3-week cycle for 2 to 4 cycles, followed by surgical resection (each cycle is 21 days); Platinum-based doublet chemotherapy options may include: * Cisplatin/carboplatin + pemetrexed (nonsquamous) * Cisplatin/carboplatin + paclitaxel (squamous) Arm 2C: LBL-007 and Tislelizumab and Chemotherapy Carboplatin LBL-007 + tislelizumab + chemotherapy on a 3-week cycle for 2 to 4 cycles, followed by surgical resection (each cycle is 21 days); Platinum-based doublet chemotherapy options may include: * Cisplatin/carboplatin + pemetrexed (nonsquamous) * Cisplatin/carboplatin + paclitaxel (squamous) Arm 2C: LBL-007 and Tislelizumab and Chemotherapy Paclitaxel LBL-007 + tislelizumab + chemotherapy on a 3-week cycle for 2 to 4 cycles, followed by surgical resection (each cycle is 21 days); Platinum-based doublet chemotherapy options may include: * Cisplatin/carboplatin + pemetrexed (nonsquamous) * Cisplatin/carboplatin + paclitaxel (squamous)
- Primary Outcome Measures
Name Time Method Major Pathological Response (MPR) Up to approximately 18 weeks after first dose MPR is defined as the proportion of participants with ≤ 10% residual viable tumor in the resected primary tumor and all resected lymph nodes as assessed by blinded independent pathology review (BIPR)
- Secondary Outcome Measures
Name Time Method Pathological complete response (pCR) Up to approximately 18 weeks after first dose pCR is defined as the proportion of participants with absence of residual tumor in the resected primary tumor and all resected lymph nodes as assessed by the BIPR
Event-free survival (EFS) Up to approximately 2 years EFS is defined as the time from randomization until any of the following events, whichever occurs first: radiographic disease progression that precludes definitive surgery, local or distant recurrence, as assessed by investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause
Overall survival (OS) Up to approximately 2 years OS is defined as the time from the date of randomization to the date of death due to any cause
Disease-free survival (DFS) Up to approximately 2 years DFS is defined as the time from the first date of no disease (ie, participants who underwent margin-negative \[R0\] resection) to local or distant recurrence, as assessed by the investigator according to RECIST v1.1, or death due to any cause, whichever occurs first
Number of participants with adverse events Up to approximately 2 years Number of participants with treatment-emergent adverse events, including serious adverse events and immune-mediated adverse events (imAEs), with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Proportion of participants who undergo surgical resection Up to approximately 18 weeks after first dose Proportion of participants who undergo surgical resection within a scheduled period after receiving any dose of investigational agents, delayed or canceled surgery, duration of surgery and surgical approach
Trial Locations
- Locations (14)
Hwa Mei Hospital, University of Chinese Academy of Sciences (Ningbo No Hospital)
🇨🇳Ningbo, Zhejiang, China
The First Affiliated Hospital of Wannan Medical College
🇨🇳Wuhu, Anhui, China
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China
The First Affiliated Hospital of Guangzhou Medical Universitydatansha Hospital)
🇨🇳Guangzhou, Guangdong, China
The Tumor Hospital Affiliated to Guangxi Medical University
🇨🇳Nanning, Guangxi, China
Anyang Cancer Hospital
🇨🇳Anyang, Henan, China
Hubei Cancer Hospital
🇨🇳Wuhan, Hubei, China
Liaoning Cancer Hospital and Institute
🇨🇳Shenyang, Liaoning, China
Shandong Cancer Hospital
🇨🇳Jinan, Shandong, China
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, Shanghai, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
The First Affiliated Hospital of Nanchang University Branch Xianghu
🇨🇳Nanchang, Jiangxi, China
Shanghai Pulmonary Hospital
🇨🇳Shanghai, Shanghai, China