Clinical Trials /

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

NCT04952597

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.

Related Conditions:
  • Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

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

DrugSynonymsArms
OciperlimabBGB-A1217Arm A: Ociperlimab
TislelizumabBGB-A317Arm A: Ociperlimab
Concurrent ChemoradiotherapyArm 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

NameTypeDescriptionInterventions
Arm A: OciperlimabExperimentalParticipants 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: TislelizumabExperimentalParticipants 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)ExperimentalParticipants 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