Phase 2
N=126
Study of Ociperlimab Plus Tislelizumab Plus Chemoradiotherapy in Participants With Untreated Limited-Stage Small Cell Lung Cancer
Limited Stage Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04952597 ↗Enrolled (actual)
126
Serious AEs
45.2%
Results posted
Sep 2024
Primary outcome: Primary: Progression Free Survival (PFS) — 12.6; 13.2; 9.5 Months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ociperlimab (Drug); Tislelizumab (Drug); Concurrent Chemoradiotherapy (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- BeiGene
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) |
12.6; 13.2; 9.5 | — |
| SECONDARY Complete Response Rate (CR) |
7.3; 9.5; 2.3 | — |
| SECONDARY Overall Response Rate (ORR) |
85.4; 88.1; 76.7 | — |
| SECONDARY Overall Response Rate (ORR) in the Programmed Death-Ligand 1 (PD-L1) Analysis Set |
85.7; 94.1; 76.5; 93.8; 81.8; 86.7 | — |
| SECONDARY Overall Response Rate (ORR) in the T Cell Immunoreceptor With Immunoglobulin and ITIM Domain (TIGIT) Analysis Set |
88.9; 88.0; 93.8; 86.7; 100.0; 68.4 | — |
| SECONDARY Duration of Response (DOR) |
10.1; 11.5; 8.2 | — |
| SECONDARY Overall Survival (OS) in the ITT Analysis Set |
NA; NA; NA | — |
| SECONDARY Overall Survival (OS) in the PD-L1 Analysis Set |
NA; NA; NA; NA; NA; NA | — |
| SECONDARY Overall Survival (OS) in the TIGIT Analysis Set |
NA; NA; NA; NA; NA; NA | — |
| SECONDARY Distant Metastasis-free Survival (DMFS) |
17.9; 15.3; 20.0 | — |
| SECONDARY PFS in the PD-L1 Analysis Set |
12.6; 15.0; 11.1; 10.3; 14.8; 14.4 | — |
| SECONDARY PFS in the TIGIT Analysis Set |
17.9; 14.3; 11.2; 8.7; NA; 14.4 | — |
| SECONDARY Number of Participants Experiencing Adverse Events (AEs) |
41; 42; 43; 25; 20; 12 | — |
Summary
This phase 2 trial examined whether the preliminary efficacy and safety of ociperlimab, tislelizumab, and cCRT when used in combination is expected to advance treatment options in the serious unmet medical need population of Limited-Stage Small Cell Lung Cancer (LS-SCLC) participants .
Eligibility Criteria
Key Inclusion Criteria
- Participant 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.
- Participant has not received any prior treatment for LS-SCLC.
- Participant 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 participant 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
Data sourced from ClinicalTrials.gov (NCT04952597). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.