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

BeiGene

Status and phase

Completed

Phase 2

Conditions

Limited Stage Small Cell Lung Cancer

Treatments

Drug: Concurrent Chemoradiotherapy

Drug: Tislelizumab

Drug: Ociperlimab

Study type

Interventional

Funder types

Industry

Identifiers

NCT04952597

CTR20211531 (Other Identifier)

AdvanTIG-204

BGB-A317-A1217-204 (Other Identifier)

Details and patient eligibility

About

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 .

Enrollment

126 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

126 participants in 3 patient groups

Arm A: Ociperlimab + Tislelizumab

Experimental group

Description:

Ociperlimab plus tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles (each cycle is 28 days), followed by ociperlimab plus tislelizumab

Treatment:

Drug: Ociperlimab

Drug: Tislelizumab

Drug: Concurrent Chemoradiotherapy

Arm B: Tislelizumab

Experimental group

Description:

Tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles, followed by tislelizumab alone

Treatment:

Drug: Tislelizumab

Drug: Concurrent Chemoradiotherapy

Arm C: Concurrent Chemoradiotherapy (cCRT)