Description:
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.
Title
- Brief Title: Study of Ociperlimab Plus Tislelizumab Plus Chemoradiotherapy in Participants With Untreated Limited-Stage Small Cell Lung Cancer
- Official Title: 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
Clinical Trial IDs
- ORG STUDY ID:
AdvanTIG-204
- NCT ID:
NCT04952597
Conditions
- Limited Stage Small Cell Lung Cancer
Interventions
Drug | Synonyms | Arms |
---|
Ociperlimab | BGB-A1217 | Arm A: Ociperlimab |
Tislelizumab | BGB-A317 | Arm A: Ociperlimab |
Concurrent Chemoradiotherapy | | Arm A: Ociperlimab |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Arm A: Ociperlimab | Experimental | Participants will receive ociperlimab 900 mg intravenously once every 3 weeks plus tislelizumab 200 mg intravenously once every 3 weeks combined with cCRT for 4 cycles, followed by ociperlimab 900 mg intravenously once every 3 weeks plus tislelizumab 200 mg intravenously once every 3 weeks. | - Ociperlimab
- Tislelizumab
- Concurrent Chemoradiotherapy
|
Arm B: Tislelizumab | Experimental | Participants will receive tislelizumab 200 mg intravenously once every 3 weeks combined with cCRT for 4 cycles, followed by tislelizumab 200 mg intravenously once every 3 weeks. | - Tislelizumab
- Concurrent Chemoradiotherapy
|
Arm C: Concurrent Chemoradiotherapy (cCRT) | Experimental | Participants will receive cCRT only for 4 cycles. | - Concurrent Chemoradiotherapy
|
Eligibility Criteria
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 appl
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Progression free survival (PFS) |
Time Frame: | 30 months from First Patient In date |
Safety Issue: | |
Description: | Determined from investigator derived tumor assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1. |
Secondary Outcome Measures
Measure: | Complete Response (CR) rate as assessed by investigator per RECIST v1.1 |
Time Frame: | 30 months from First Patient In date |
Safety Issue: | |
Description: | Determined from investigator derived tumor assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1. |
Measure: | Duration of response (DOR) |
Time Frame: | 30 months from First Patient In date |
Safety Issue: | |
Description: | Determined from investigator derived tumor assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1. |
Measure: | Overall Response Rate (ORR) |
Time Frame: | 30 months from First Patient In date |
Safety Issue: | |
Description: | Determined from investigator derived tumor assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1. |
Measure: | Overall Survival (OS) |
Time Frame: | 30 months from First Patient In date |
Safety Issue: | |
Description: | Determined from investigator derived tumor assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1. |
Measure: | Safety and tolerability: The incidence and severity of treatment-emergent adverse events (TEAEs) |
Time Frame: | 30 months from First Patient In date |
Safety Issue: | |
Description: | graded according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0). |
Measure: | Distant metastasis-free survival (DMFS) |
Time Frame: | 30 months from First Patient In date |
Safety Issue: | |
Description: | Determined from investigator derived tumor assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1. |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | BeiGene |
Last Updated
July 30, 2021