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)

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 investigatio

Trial Details

NCT ID

NCT06095583

Phase

PHASE3

Sponsor

Shanghai Junshi Bioscience Co., Ltd.

Status

RECRUITING

Cancer Type

Lung Cancer

Interventions

Tifcemalimab injection
toripalimab injection
Placebo for Tifcemalimab
Placebo for toripalimab

Locations (sample)

Goodyear, Arizona, United States|33.43532,-112.35821
Tucson, Arizona, United States|32.22174,-110.92648
Hot Springs, Arkansas, United States|34.5037,-93.05518
Davis, California, United States|38.54491,-121.74052
Los Angeles, California, United States|34.05223,-118.24368

Key Eligibility Criteria

Patients must meet all of the following inclusion criteria to be enrolled:
Male or female with age ≥ 18 years old at the time of informed consent.
Histologically or cytologically confirmed LS-SCLC using the Veteran's Administration Lung Study Arm (VALSG) staging criteria (Appendix 3). Patients…
Received CRT defined as: (1) 4 cycles of chemotherapy consisting of carboplatin or cisplatin and intravenously administered etoposide; (2) a total …

For full eligibility, visit ClinicalTrials.gov.

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