CompletedPhase 2NCT04952597
Official study title

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

Study 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 .

Ask AI to explain this study
Start here

Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedOciperlimab and Tislelizumab

Plus 1 other study approaches.

Who it may be forSmall cell lung cancer (SCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 26, 2024 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?33 U.S. locations

Locations may change over time.

Who runs it?BeiGene

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
BeiGene
Interventions being studied
Drug: Ociperlimab; Drug: Tislelizumab; Drug: Concurrent Chemoradiotherapy
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Key
  • 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
Reasons someone may not be able to joinExclusion 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/

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Tennessee Cancer SpecialistKnoxville, Tennessee
  • Peking University First HospitalBeijing, Beijing Municipality
  • Beijing Cancer HospitalBeijing, Beijing Municipality
  • Gansu Provincial Cancer HospitalLanzhou, Gansu
  • The First Affiliated Hospital, Sun Yat Sen UniversityGuangzhou, Guangdong
  • The Tumor Hospital Affiliated to Guangxi Medical UniversityNanning, Guangxi
  • Henan Cancer HospitalZhengzhou, Henan
  • The First Affiliated Hospital of Zhengzhou UniversityZhengzhou, Henan
  • Union Hospital of Tongji Medical College, Huazhong University of Science and TechnologyWuhan, Hubei
  • The Second Xiangya Hospital of Central South UniversityChangsha, Hunan
  • Hunan Cancer HospitalChangsha, Hunan
  • Huai An First Peoples HospitalHuaian, Jiangsu

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 26, 2024. Always confirm current availability with the study team.

View original record ↗