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Phase 3 Study of Toripalimab Alone or in Combination With Tifcemalimab as Consolidation Therapy in Patients With Limited-stage Small Cell Lung Cancer (LS-SCLC)

NCT06095583 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 756

Last updated 2024-06-21

No results posted yet for this study

Summary

The Study is a Phase 3, randomized, three-arm, double-blind, placebo-controlled, multi-regional clinical research study to evaluate the safety and efficacy use of toripalimab alone or in combination with tifcemalimab as consolidation therapy in patients with limited-stage small cell lung cancer without disease progression following chemoradiotherapy.

Tifcemalimab is a monoclonal antibody against B and T lymphocyte attenuator (BTLA). Toripalimab is a monoclonal antibody against programmed death protein-1 (PD-1). Neither drug is approved for treatment of This combination regimen is investigational in limited stage-small cell lung cancer in any country.

Conditions

  • Limited-stage Small Cell Lung Cancer (LS-SCLC)

Interventions

DRUG

Tifcemalimab injection

200mg once every 3weeks

DRUG

toripalimab injection

240mg once every 3 weeks

DRUG

Placebo for Tifcemalimab

every 3weeks

DRUG

Placebo for toripalimab

every 3weeks

Sponsors & Collaborators

  • Shanghai Junshi Bioscience Co., Ltd.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-15
Primary Completion
2027-07-31
Completion
2029-07-31
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • China
  • France
  • Georgia
  • Germany
  • Italy
  • Netherlands
  • Poland
  • Romania
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)

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 NCT06095583 on ClinicalTrials.gov