Study of Ociperlimab Plus Tislelizumab Plus Chemoradiotherapy in Participants With Untreated Limited-Stage Small Cell Lung Cancer
- Conditions
- Limited Stage Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT04952597
- Lead Sponsor
- BeiGene
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 126
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A: Ociperlimab + Tislelizumab Ociperlimab Ociperlimab plus tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles (each cycle is 28 days), followed by ociperlimab plus tislelizumab Arm A: Ociperlimab + Tislelizumab Concurrent Chemoradiotherapy Ociperlimab plus tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles (each cycle is 28 days), followed by ociperlimab plus tislelizumab Arm B: Tislelizumab Concurrent Chemoradiotherapy Tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles, followed by tislelizumab alone Arm C: Concurrent Chemoradiotherapy (cCRT) Concurrent Chemoradiotherapy cCRT only for 4 cycles at the investigator's discretion Arm A: Ociperlimab + Tislelizumab Tislelizumab Ociperlimab plus tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles (each cycle is 28 days), followed by ociperlimab plus tislelizumab Arm B: Tislelizumab Tislelizumab Tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles, followed by tislelizumab alone
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) Up to approximately 2 years Defined as the time from the date of randomization to the date of the first documented disease progression as determined by the investigator per RECIST v1.1 or death from any cause (whichever occurs first)
- Secondary Outcome Measures
Name Time Method PFS in the TIGIT Analysis Set Up to approximately 2 years defined as the time from the date of randomization to the date of the first documented disease progression as determined by the investigator per RECIST v1.1 or death from any cause (whichever occurs first),
Number of Participants Experiencing Adverse Events (AEs) From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v4.03
Complete Response Rate (CR) Up to approximately 2 years defined as the percentage of participants who had CR as assessed by the investigator per RECIST v1.1
Overall Response Rate (ORR) Up to approximately 2 years defined as the percentage of participants who had CR or partial response (PR) as assessed by the investigator per RECIST v1.1
Overall Response Rate (ORR) in the Programmed Death-Ligand 1 (PD-L1) Analysis Set Up to approximately 2 years defined as the percentage of participants who had CR or partial response (PR) as assessed by the investigator per RECIST v1.1
Overall Response Rate (ORR) in the T Cell Immunoreceptor With Immunoglobulin and ITIM Domain (TIGIT) Analysis Set Up to approximately 2 years defined as the percentage of participants who had CR or partial response (PR) as assessed by the investigator per RECIST v1.1
Duration of Response (DOR) Up to approximately 2 years defined as the time from the date of the first occurrence of a documented objective response to the date of documented disease progression as assessed by the investigator per RECIST v1.1 or death from any cause (whichever occurs first)
Overall Survival (OS) in the ITT Analysis Set Up to approximately 2 years Defined as the time from the date of randomization to the date of death due to any cause
Overall Survival (OS) in the PD-L1 Analysis Set Up to approximately 2 years defined as the time from the date of randomization to the date of death due to any cause
Overall Survival (OS) in the TIGIT Analysis Set Up to approximately 2 years defined as the time from the date of randomization to the date of death due to any cause
Distant Metastasis-free Survival (DMFS) Up to approximately 2 years defined as the time from the date of randomization to the date of the first documented distant metastasis as assessed by the investigator per RECIST v1.1 or death from any cause (whichever occurs first)
PFS in the PD-L1 Analysis Set Up to approximately 2 years defined as the time from the date of randomization to the date of the first documented disease progression as determined by the investigator per RECIST v1.1 or death from any cause (whichever occurs first),
Trial Locations
- Locations (52)
Cancer Heartland Cancer Center
🇺🇸Garden City, Kansas, United States
XCancer Heartland Cancer Center
🇺🇸Garden City, Kansas, United States
Xcancer Tennesee Cancer Specialist
🇺🇸Knoxville, Tennessee, United States
Tennesee Cancer Specialists
🇺🇸Knoxville, Tennessee, United States
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
West China Hospital of Sichuan University
🇨🇳Sichuan, Chengdu, China
Gansu Cancer Hospital
🇨🇳Lanzhou, Gansu, China
The First Affiliated Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
The People's Hospital of Guangxi Zhuang Autonomous Region
🇨🇳Nanning, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
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