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RecruitingInterventionalPhase 3

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

NCT ID: NCT06095583Sponsor: Shanghai Junshi Bioscience Co., Ltd.Last updated: 2024-06-21

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.

Arms & interventions

  • DrugTifcemalimab injection

    200mg once every 3weeks

  • Drugtoripalimab injection

    240mg once every 3 weeks

  • DrugPlacebo for Tifcemalimab

    every 3weeks

  • DrugPlacebo for toripalimab

    every 3weeks

Outcome measures

Primary

  • Overall survival (OS)

    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

    Time frame: up to 3years

  • 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"

    Time frame: up to 3years

  • Progression-free survival (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 Blinded Independent Review Committee (BIRC)-assessed PFS.

    Time frame: up to 2years

  • Progression-free survival (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.

    Time frame: up to 2years

Secondary

  • PFS

    Time frame: up to 2years

  • 1-year OS rate

    Time frame: up to 1year

  • 2-year OS rate

    Time frame: up to 2 years

  • objective response rate (ORR)

    Time frame: up to 2 years

  • disease control rate (DCR)

    Time frame: up to 2 years

  • duration of response (DoR)

    Time frame: up to 2years

  • PFS

    Time frame: up to 2 years

  • 1 year OS rate

    Time frame: up to 1 years

  • 2 year OS rate

    Time frame: up to 2 years

  • ORR

    Time frame: up to 2 years

  • DCR

    Time frame: up to 2 years

  • DoR

    Time frame: up to 2 years

  • safety

    Time frame: up to 2 years

  • safety

    Time frame: up to 2 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 (Appendix 3). Patients with TNM Stage I or II disease per AJCC 8th edition must be medically inoperable (as determined by the Investigator) or the patient must refuse surgery. 3. Received CRT defined as: (1) 4 cycles of chemotherapy consisting of carboplatin or cisplatin and intravenously administered etoposide; (2) a total radiation dose of 60-66 Gy for the standard once daily (QD) radiotherapy regimen or 45 Gy for the hyperfractionated twice daily (BID) radiotherapy regimen; (3) Patients must begin investigational interventions within 42 days of the last dose of chemotherapy. 4. Patients must have achieved a complete response (CR), partial response (PR), or stable disease (SD) after receiving curative platinum-based CRT and must not have developed progressive disease (PD) prior to study entry. 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1 . 6. Adequate organ function 7. Female patients of childbearing potential and male patients whose partners are women of childbearing age. 8. Voluntarily agree to participate in the study, sign the informed consent form, and agree to comply with all study and follow-up procedures. Exclusion Criteria: Patients will be excluded from the study if they meet any of the following criteria. 1. Mixed SCLC and non-small cell lung cancer (NSCLC). 2. Received sequential chemoradiotherapy for LS-SCLC. 3. Failure to recover from toxicity of prior anticancer therapy to Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤ 1 (except alopecia) or levels specified in the inclusion/exclusion criteria, whichever is more severe. 4. Patients with active autoimmune disease, history of autoimmune disease. 5. History of immunodeficiency, including HIV seropositivity, other acquired congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation. 6. History of confirmed or suspected interstitial lung disease or pneumonitis (except for Grade 1 radiation pneumonitis not treated with corticosteroids). 7. The presence of active hepatitis B (HBV DNA ≥ 500 IU/mL), hepatitis C (hepatitis C antibodies positive and HCV-RNA higher than the lower limit of detection of the analytical method). 8. Any other malignancy diagnosed prior to the first dose of investigational intervention, except those with a low risk for the development of metastases (5-year survival rate \> 90%), such as adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix or breast, or adequately treated localized prostate cancer. 9. Women who are pregnant or breastfeeding.

Study locations (29)

Banner MD Anderson Cancer Center

Goodyear, Arizona, 85338

Not Yet Recruiting
Jiaxin Niu · Contact

Banner University Medical Center

Tucson, Arizona, 85713

Not Yet Recruiting
Charles Hsu · Contact

Genesis Cancer and Blood Institute (Hot Springs, AR)

Hot Springs, Arkansas, 05001

Not Yet Recruiting
Roy Timothy Webb · Contact

SCRI Nashville

Davis, California, 95616

Not Yet Recruiting
Jhonson Melissa · Contact

Zangmeister Cancer Center (Columbus, OH)

Los Angeles, California, 43219

Not Yet Recruiting
Jorge Rios-Perez · Contact

Los Angeles Hematology Oncology

Los Angeles, California, 90033

Not Yet Recruiting
Lasika Seneviratne, · Contact

University of Southern California Norris Comprehensive Cancer

Los Angeles, California, 90033

Recruiting
Robert Hsu, · Contact

Florida Cancer Specialists Pan Handle

Fort Myers, Florida, 32310

Not Yet Recruiting
Jeffrey Bubis · Contact

Florida Cancer Specialists South

Fort Myers, Florida, 33908

Not Yet Recruiting
Alexander Glick · Contact

USA029 University of Miami Sylvester Comprehensive Cancer Center 1550 NW 10th Avenue 33173 Miami FL Ikpeazu Chukwuemeka N

Miami, Florida, 33173

Not Yet Recruiting
Ikpeazu Chukwuemeka · Contact

Mid-Florida Hematology Oncology

Orange City, Florida, 55905

Recruiting
Santosh Nair · Contact

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

Marietta, Georgia, 30060

Not Yet Recruiting
Steven McCune, · Contact

Norton Cancer Institute, Downtown, Multidisciplinary Clinic

Louisville, Kentucky, 40241

Not Yet Recruiting
Lye Adam · Contact

American Oncology Partners of Maryland, PA

Bethesda, Maryland, 20817

Recruiting
Boccia Ralph · Contact

Dana Farber Cancer Institute-Hematology/Oncology

Boston, Massachusetts, 461099

Not Yet Recruiting
Jacob Sands · Contact

Karmanos Cancer Center

Detroit, Michigan, 48201

Not Yet Recruiting
Mamdani Hirva · Contact

Henry Ford Health System

Detroit, Michigan, 48202

Not Yet Recruiting
Bindu Potugari, · Contact

Cancer and Hematology Centers of Western Michigan

Grand Rapids, Michigan, 49502

Recruiting
Yuanbin Chen · Contact

Washington University School of Medicine - Siteman Cancer Center

St Louis, Missouri, 63101

Not Yet Recruiting
Haobin Chen · Contact

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756

Not Yet Recruiting
Charles Hsu · Contact

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 07101

Not Yet Recruiting
Missak Haigentz · Contact

North Shore Hematology Oncology Associates DBA NY Cancer and Blood Specialists

New York, New York, 11776

Not Yet Recruiting
Richard Zuniga · Contact

University of Stony Brook

Stony Brook, New York, 11794

Not Yet Recruiting
Amna Sher · Contact

Toledo Clinic Cancer Center - Toledo

Toledo, Ohio, 97391

Recruiting
Rex Mowat · Contact

Oncology Associates Of Oregon, P.C.

Eugene, Oregon, 97401

Not Yet Recruiting
Bo Wang · Contact

Oregon Health and Science University

Portland, Oregon, 97239

Not Yet Recruiting
Cetnar Jeremy · Contact

Millennium Physicians - Oncology

Houston, Texas, 77090

Recruiting
Anirudha Dasgupta, · Contact

Texas Oncology, P.A. - Oncology

Tyler, Texas, 97402

Not Yet Recruiting
Richards Donald · Contact

Virginia Cancer Specialists

Fairfax, Virginia, 22030

Not Yet Recruiting
Alexander Spira · Contact