Efficacy, Safety, and Pharmacodynamics of Tislelizumab Monotherapy and Multiple Tislelizumab-based Immunotherapy Combinations in Participants With Resectable Non-Small Cell Lung Cancer

Non Small Cell Lung Cancer Clinical Trial

Official title:

A Randomized, Open-Label, Multicenter, Phase 2, Umbrella Study to Evaluate the Preliminary Efficacy, Safety, and Pharmacodynamics of Tislelizumab Monotherapy and Multiple Tislelizumab-based Immunotherapy Combinations With and Without Chemotherapy as Neoadjuvant Treatment in Chinese Patients With Resectable Stage II to IIIA Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05577702
• Other study ID #: BGB-LC-202
• Secondary ID: CTR20222760
• Status: Recruiting
• Phase: Phase 2
• Start date: February 16, 2023
• Est. completion date: December 2026

Study information

• Verified date: June 2024
• Source: BeiGene
• Contact: Study Director
• Phone: 1-877-828-5568
• Email: clinicaltrials[@]beigene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Drug:
• Tislelizumab
Administered as an intravenous infusion
• Ociperlimab
Administered as an intravenous infusion
• LBL-007
Administered as an intravenous infusion
• Cisplatin
Administered as an intravenous infusion
• Carboplatin
Administered as an intravenous infusion
• Pemetrexed
Administered as an intravenous infusion
• Paclitaxel
Administered as an intravenous infusion

Locations

Country	Name	City	State
China	Anyang Cancer Hospital	Anyang	Henan
China	Beijing Cancer Hospital	Beijing	Beijing
China	Hunan Cancer Hospital	Changsha	Hunan
China	Fujian Medical University Union Hospital	Fuzhou	Fujian
China	The First Affiliated Hospital of Guangzhou Medical Universitydatansha Hospital)	Guangzhou	Guangdong
China	Shandong Cancer Hospital	Jinan	Shandong
China	The First Affiliated Hospital of Nanchang University Branch Xianghu	Nanchang	Jiangxi
China	The Tumor Hospital Affiliated to Guangxi Medical University	Nanning	Guangxi
China	Hwa Mei Hospital, University of Chinese Academy of Sciences (Ningbo No Hospital)	Ningbo	Zhejiang
China	Rui Jin Hospital Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Shanghai Pulmonary Hospital	Shanghai	Shanghai
China	Liaoning Cancer Hospital and Institute	Shenyang	Liaoning
China	Hubei Cancer Hospital	Wuhan	Hubei
China	The First Affiliated Hospital of Wannan Medical College	Wuhu	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
BeiGene

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Pathological Response (MPR)	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)	Up to approximately 18 weeks after first dose
Secondary	Pathological complete response (pCR)	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	Up to approximately 18 weeks after first dose
Secondary	Event-free survival (EFS)	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	Up to approximately 2 years
Secondary	Overall survival (OS)	OS is defined as the time from the date of randomization to the date of death due to any cause	Up to approximately 2 years
Secondary	Disease-free survival (DFS)	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	Up to approximately 2 years
Secondary	Number of participants with adverse events	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	Up to approximately 2 years
Secondary	Proportion of participants who undergo surgical resection	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	Up to approximately 18 weeks after first dose
Secondary	Serum or plasma concentrations of investigational agents		Up to 30 days after last dose
Secondary	Number of participants with anti-drug antibodies (ADAs)		Up to 30 days after last dose