Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Small Cell Lung Carcinoma

Lung Neoplasms

Disease Progression

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

Tifcemalimab (200 mg intravenous infusion \[IV\]) and toripalimab (240 mg IV)

Placebo for tifcemalimab (IV) and toripalimab (240 mg IV)

Placebos for both tifcemalimab and toripalimab (IV)

Tifcemalimab injection

toripalimab injection

Placebo for Tifcemalimab

Placebo for toripalimab

kui zhang, Project Directer

Kinga Kovacs, Senior Project Leader

Jiaxin Niu

Charles Hsu

Roy Timothy Webb

Jhonson Melissa

Jorge Rios-Perez

Lasika Seneviratne,

Robert Hsu,

Jeffrey Bubis

Alexander Glick

Ikpeazu Chukwuemeka

Santosh Nair

Steven McCune,

Lye Adam

Boccia Ralph

Jacob Sands

Mamdani Hirva

Bindu Potugari,

Yuanbin Chen

Haobin Chen

Missak Haigentz

Richard Zuniga

Amna Sher

Rex Mowat

Bo Wang

Cetnar Jeremy

Anirudha Dasgupta,

Richards Donald

Alexander Spira

Wim Demey

Colinet Benoit

Sofie Derijcke

Kristof Cuppens

Jean-Charles Goeminne

Yan Yu

Rongrong Zhou

Anwen Liu

Bo Jin

Jinming Yu, MD, PhD,

Anping Zheng

Anhui Shi

Zhouguang Hui

Ying Cheng

Hui Wang

Wenxiu Yao

Ying Wang

Yajie Liu

Ming Chen

Yongling Ji

Wen Li

Dong Qian

Junqiang Zhang

Hong Ge

Shucheng Ye

Longhua Sun

Jing Wang

Ming Fan

Xiaoling Li

Jie Li

Dongqing Lv

Lujun Zhao

Desheng Hu

Yi Peng

Conghua Xie

Qin Lin

Ren Zhao

Youssef Oulkhouir

Sophie Cousin

Isabelle Monnet

Denis Moro-Sibilot

Maurice Perol

Ivan Toledano

Jean-Louis Pujol

Remi Veillon

Florian Guisier

Sandrine Hiret

Eric Pichon

Lavaud Pernelle

Mariam Zhvania

Vladimer Kuchava

Ekaterine Arkania

Davit Giorgadze

Tsira Kortua

Miranda Gogishvili

Christian Grohé

Martin Faehling

Thomas Wehler

Martin Wolf

Rüdiger Liersch

Christian Schulz

Hector Jose Soto Parra

Angelo Delmonte

Lorenzo Antonuzzo

Bertolini Federica

Ferdinando Riccardi

Laura Bonnano

Andrea Filippi

Ricciardi Serena

Federico Cappuzzo

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.

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)

A Randomized, Double-Blind, Placebo-Controlled, Multi-Regional Phase III Clinical Study of Toripalimab Alone or in Combination With Tifcemalimab (JS004/TAB004) as Consolidation Therapy in Patients With Limited-Stage Small Cell Lung Cancer Without Disease Progression Following Chemoradiotherapy

To compare and evaluate the efficacy of tifcemalimab and toripalimab (Arm A) versus placebo (Arm C) as consolidation therapy after chemoradiotherapy (CRT) for patients with LS-SCLC as measured by OS

To compare and evaluate the efficacy of toripalimab (Arm B) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLC as measured by OS"

To compare and evaluate the efficacy of tifcemalimab and toripalimab (Arm A) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLC as measured by Blinded Independent Review Committee (BIRC)-assessed PFS.

To compare and evaluate the efficacy of toripalimab (Arm B) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLC as measured by OS and BIRC-assessed PFS.

To compare and evaluate the efficacy of tifcemalimab and toripalimab (Arm A) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLC as measured by Investigator-assessed PFS

To compare and evaluate the efficacy of tifcemalimab and toripalimab (Arm A) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLC as measured by 1-year OS rate

To compare and evaluate the efficacy of tifcemalimab and toripalimab (Arm A) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLC as measured by 2-year OS rate

To compare and evaluate the efficacy of tifcemalimab and toripalimab (Arm A) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLC as measured by ORR

To compare and evaluate the efficacy of tifcemalimab and toripalimab (Arm A) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLC as measured by DCR

To compare and evaluate the efficacy of tifcemalimab and toripalimab (Arm A) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLC as measured by DoR

To compare and evaluate the efficacy of toripalimab (Arm B) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLS as measured by Investigator-assessed PFS

To compare and evaluate the efficacy of toripalimab (Arm B) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLS as measured by 1-year OS rate

To compare and evaluate the efficacy of toripalimab (Arm B) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLS as measured by 2-year OS rate

To compare and evaluate the efficacy of toripalimab (Arm B) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLS as measured by ORR

To compare and evaluate the efficacy of toripalimab (Arm B) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLS as measured by DCR

To compare and evaluate the efficacy of toripalimab (Arm B) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLS as measured by DoR

To compare and evaluate the safety of tifcemalimab and toripalimab (Arm A) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLC as measured by the incidence of adverse events (Percentage of participants with treatment-related adverse events as assessed by CTCAEv5.0.) and abnormal laboratory parameters.

To compare and evaluate the safety of toripalimab (Arm B) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLC as measured by the incidence of adverse events (Percentage of participants with treatment-related adverse events as assessed by CTCAEv5.0.) and abnormal laboratory parameters.

Shanghai Junshi Bioscience Co., Ltd.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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	Limited-stage S...	Tifcemalimab in... toripalimab inj... Placebo for Tif... Placebo for tor...	18 Years -	Shanghai Junshi Bioscience Co., Ltd.
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	Limited-stage S...	Tifcemalimab in... toripalimab inj... Placebo for Tif... Placebo for tor...	18 Years -	Shanghai Junshi Bioscience Co., Ltd.

Spots Global Cancer Trial Database for placebo for toripalimab