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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04952597
Recruitment Status : Recruiting
First Posted : July 7, 2021
Last Update Posted : November 30, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Limited Stage Small Cell Lung Cancer Drug: Ociperlimab Drug: Tislelizumab Drug: Concurrent Chemoradiotherapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 15, 2021
Estimated Primary Completion Date : March 30, 2024
Estimated Study Completion Date : March 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A: Ociperlimab + Tislelizumab
Ociperlimab + tislelizumab + cCRT for 4 cycles followed by ociperlimab + tislelizumab
Drug: Ociperlimab
Ociperlimab is a monoclonal antibody formulated for intravenous injection.
Other Name: BGB-A1217

Drug: Tislelizumab
Tislelizumab is a monoclonal antibody formulated for intravenous injection.
Other Name: BGB-A317

Drug: Concurrent Chemoradiotherapy
Cisplatin / Carboplatin and Etoposide, intravenous therapy Radiotherapy

Experimental: Arm B: Tislelizumab
Tislelizumab + cCRT for 4 cycles followed by tislelizumab alone
Drug: Tislelizumab
Tislelizumab is a monoclonal antibody formulated for intravenous injection.
Other Name: BGB-A317

Drug: Concurrent Chemoradiotherapy
Cisplatin / Carboplatin and Etoposide, intravenous therapy Radiotherapy

Experimental: Arm C: Concurrent Chemoradiotherapy (cCRT)
cCRT for 4 cycles
Drug: Concurrent Chemoradiotherapy
Cisplatin / Carboplatin and Etoposide, intravenous therapy Radiotherapy




Primary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: 30 months from First Patient In date ]
    Determined from investigator derived tumor assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1.


Secondary Outcome Measures :
  1. Complete Response (CR) rate as assessed by investigator per RECIST v1.1 [ Time Frame: 30 months from First Patient In date ]
    Determined from investigator derived tumor assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1.

  2. Duration of response (DOR) [ Time Frame: 30 months from First Patient In date ]
    Determined from investigator derived tumor assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1.

  3. Overall Response Rate (ORR) [ Time Frame: 30 months from First Patient In date ]
    Determined from investigator derived tumor assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1.

  4. Overall Survival (OS) [ Time Frame: 30 months from First Patient In date ]
    Determined from investigator derived tumor assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1.

  5. Safety and tolerability: The incidence and severity of treatment-emergent adverse events (TEAEs) [ Time Frame: 30 months from First Patient In date ]
    graded according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0).

  6. Distant metastasis-free survival (DMFS) [ Time Frame: 30 months from First Patient In date ]
    Determined from investigator derived tumor assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04952597


Contacts
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Contact: BeiGene 1-877-828-5568 clinicaltrials@beigene.com

Locations
Show Show 53 study locations
Sponsors and Collaborators
BeiGene
Investigators
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Study Director: Study Director BeiGene
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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT04952597    
Other Study ID Numbers: AdvanTIG-204
First Posted: July 7, 2021    Key Record Dates
Last Update Posted: November 30, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms