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Completed

NCT Number: NCT04952597

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

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 .

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Key information

Conditions

Limited Stage Small Cell Lung Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beijing Cancer Hospital, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ociperlimab

Drug

Ociperlimab 900 milligrams (mg) administered intravenously once every 3 weeks on Day 1 of each cycle

Other names: BGB-A1217

Tislelizumab

Drug

Tislelizumab 200 mg administered intravenously once every 3 weeks on Day 1 of each cycle

Other names: BGB-A317

Concurrent Chemoradiotherapy

Drug

Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.

Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles

Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)

Primary outcomes

  1. Progression Free Survival (PFS)

    Time frame: Up to approximately 2 years

    Defined as the time from the date of randomization to the date of the first documented disease progression as determined by the investigator per RECIST v1.1 or death from any cause (whichever occurs first)

Secondary outcomes

  1. Complete Response Rate (CR)

    Time frame: Up to approximately 2 years

    defined as the percentage of participants who had CR as assessed by the investigator per RECIST v1.1

  2. Overall Response Rate (ORR)

    Time frame: Up to approximately 2 years

    defined as the percentage of participants who had CR or partial response (PR) as assessed by the investigator per RECIST v1.1

  3. Overall Response Rate (ORR) in the Programmed Death-Ligand 1 (PD-L1) Analysis Set

    Time frame: Up to approximately 2 years

    defined as the percentage of participants who had CR or partial response (PR) as assessed by the investigator per RECIST v1.1

  4. Overall Response Rate (ORR) in the T Cell Immunoreceptor With Immunoglobulin and ITIM Domain (TIGIT) Analysis Set

    Time frame: Up to approximately 2 years

    defined as the percentage of participants who had CR or partial response (PR) as assessed by the investigator per RECIST v1.1

  5. Duration of Response (DOR)

    Time frame: Up to approximately 2 years

    defined as the time from the date of the first occurrence of a documented objective response to the date of documented disease progression as assessed by the investigator per RECIST v1.1 or death from any cause (whichever occurs first)

  6. Overall Survival (OS) in the ITT Analysis Set

    Time frame: Up to approximately 2 years

    Defined as the time from the date of randomization to the date of death due to any cause

  7. Overall Survival (OS) in the PD-L1 Analysis Set

    Time frame: Up to approximately 2 years

    defined as the time from the date of randomization to the date of death due to any cause

  8. Overall Survival (OS) in the TIGIT Analysis Set

    Time frame: Up to approximately 2 years

    defined as the time from the date of randomization to the date of death due to any cause

  9. Distant Metastasis-free Survival (DMFS)

    Time frame: Up to approximately 2 years

    defined as the time from the date of randomization to the date of the first documented distant metastasis as assessed by the investigator per RECIST v1.1 or death from any cause (whichever occurs first)

  10. PFS in the PD-L1 Analysis Set

    Time frame: Up to approximately 2 years

    defined as the time from the date of randomization to the date of the first documented disease progression as determined by the investigator per RECIST v1.1 or death from any cause (whichever occurs first),

  11. PFS in the TIGIT Analysis Set

    Time frame: Up to approximately 2 years

    defined as the time from the date of randomization to the date of the first documented disease progression as determined by the investigator per RECIST v1.1 or death from any cause (whichever occurs first),

  12. Number of Participants Experiencing Adverse Events (AEs)

    Time frame: From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years

    Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v4.03

Sponsors and collaborators

Lead sponsor

BeiGene

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 7, 2021
Registry last updated
Oct 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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