Study of Ociperlimab Plus Tislelizumab Plus Chemoradiotherapy in Participants With Untreated Limited-Stage Small Cell Lung Cancer

Study Overview
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Brief Summary
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This phase 2 trial examining the combination of ociperlimab plus tislelizumab plus cCRT is expected to provide valuable data to advance treatment options in the serious unmet medical need population of LS-SCLC patients. Immunotherapy combined with chemoradiotherapy may have a synergetic anti -cancer activities. The combination of anti-TIGIT antibody and anti-PD-1/L1 antibody may augment the immune effect with tolerable safety profile. The novel therapeutic strategy with dule immune therapy in combination with CRT is expected to provide valuable data to advance treatment options in the population of LS-SCLC patients.

Official Title
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A Phase 2, Multicenter, Randomized, 3-Arm, Open-Label Study to Investigate the Preliminary Efficacy and Safety of the Anti-TIGIT Monoclonal Antibody Ociperlimab (BGB-A1217) Plus Tislelizumab Plus Concurrent Chemoradiotherapy in Patients With Untreated Limited-Stage Small Cell Lung Cancer

Conditions
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Limited Stage Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Ociperlimab
* Drug: Tislelizumab
* Drug: Concurrent Chemoradiotherapy


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Patient has pathologically (histologically or cytologically) proven diagnosis of small cell lung cancer Has limited-stage disease (stage Tx, T1-T4, N0-3, M0; AJCC staging, 8th edition), and can be safely treated with definitive radiation doses. Patient has not received any prior treatment for LS-SCLC. Patient has measurable disease as assessed according to RECIST v1.1 that is appropriate for selection as a target lesion for repeat measurement, as determined by local site investigator/radiology review ECOG Performance Status ≤ 2 assessed within 7 days before the first administration of study intervention, and must have a life expectancy of ≥ 12 weeks. Key Exclusion Criteria: Mixed small cell lung cancer histology. Note: mixed SCLC with the component of neuroendocrine carcinoma origin is considered eligible Have received surgical resection for LS-SCLC Any patient for whom the tumor is considered resectable by surgery or stereotactic body radiation therapy/stereotactic ablative radiotherapy should be considered ineligible Is expected to require any other form of antineoplastic therapy while on study. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-TIGIT, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways Note: Other protocol-defined Inclusion/Exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A: Ociperlimab + Tislelizumab<br>Ociperlimab + tislelizumab + cCRT for 4 cycles followed by ociperlimab + tislelizumab | Drug: Ociperlimab<br>* Ociperlimab is a monoclonal antibody formulated for intravenous injection.<br>* Other names: BGB-A1217;Drug: Tislelizumab<br>* Tislelizumab is a monoclonal antibody formulated for intravenous injection.<br>* Other names: BGB-A317;Drug: Concurrent Chemoradiotherapy<br>* Cisplatin / Carboplatin and Etoposide, intravenous therapy Radiotherapy<br>|
| Experimental: Arm B: Tislelizumab<br>Tislelizumab + cCRT for 4 cycles followed by tislelizumab alone | Drug: Tislelizumab<br>* Tislelizumab is a monoclonal antibody formulated for intravenous injection.<br>* Other names: BGB-A317;Drug: Concurrent Chemoradiotherapy<br>* Cisplatin / Carboplatin and Etoposide, intravenous therapy Radiotherapy<br>|
| Experimental: Arm C: Concurrent Chemoradiotherapy (cCRT)<br>cCRT for 4 cycles | Drug: Concurrent Chemoradiotherapy<br>* Cisplatin / Carboplatin and Etoposide, intravenous therapy Radiotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival (PFS) | Determined from investigator derived tumor assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1. | 30 months from First Patient In date | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Response (CR) rate as assessed by investigator per RECIST v1.1 | Determined from investigator derived tumor assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1. | 30 months from First Patient In date | 
| Duration of response (DOR) | Determined from investigator derived tumor assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1. | 30 months from First Patient In date | 
| Overall Response Rate (ORR) | Determined from investigator derived tumor assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1. | 30 months from First Patient In date | 
| Overall Survival (OS) | Determined from investigator derived tumor assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1. | 30 months from First Patient In date | 
| Safety and tolerability: The incidence and severity of treatment-emergent adverse events (TEAEs) | graded according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0). | 30 months from First Patient In date | 
| Distant metastasis-free survival (DMFS) | Determined from investigator derived tumor assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1. | 30 months from First Patient In date |