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Pilot Study of PD-1inhibitor (Tislelizumab) Plus Chemotherapy as Neoadjuvant Therapy for Limited-Stage Small-Cell Lung Cancer

NCT04542369 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-05-03

No results posted yet for this study

Summary

This is a phase II, non-randomized, open-label, single-center study to evaluate the efficacy and safety of neoadjuvant PD-1 inhibitor (Tislelizumab) + chemotherapy (cisplatin/carboplatin + etoposide) followed by radical surgery and adjuvant Tislelizumab immunotherapy as first-line treatment in patients limited-stage SCLC.

Conditions

  • Small-cell Lung Cancer

Interventions

DRUG

Tislelizumab (BGB-A317) Plus Chemotherapy (Cisplatin/Carboplatin and Etoposide)

Inductive/neoadjuvant therapy: Tislelizumab + EP Maintenance/adjuvant therapy: Tislelizumab + EP

Sponsors & Collaborators

  • Shanghai Pulmonary Hospital, Shanghai, China

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-01
Primary Completion
2023-12-31
Completion
2025-11-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04542369 on ClinicalTrials.gov