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)

Recruiting Phase 3 Interventional Study
Limited-stage Small Cell Lung Cancer (LS-SCLC)
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
756 (estimated)
Sponsor
Shanghai Junshi Bioscience Co., Ltd. · Other
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: Patients must meet all of the following inclusion criteria to be enrolled: 1. Male or female with age ≥ 18 years old at the time of informed consent. 2. Histologically or cytologically confirmed LS-SCLC using the Veteran's Administration Lung Study Arm (VALSG) staging criteria …
Contacts

kui zhang, Project Directer

08618168028925

kui_zhang@junshipharma.com

CONTACT

Kinga Kovacs, Senior Project Leader

+ 31 6 45974346

Kinga.Kovacs@parexel.com

CONTACT