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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) | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

NCT06095583•Shanghai Junshi Bioscience Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.
•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.

Locations (156)

Banner MD Anderson Cancer Center

Goodyear, Arizona, United States

Banner University Medical Center

Tucson, Arizona, United States

Genesis Cancer and Blood Institute (Hot Springs, AR)

Hot Springs, Arkansas, United States

SCRI Nashville

Davis, California, United States

Zangmeister Cancer Center (Columbus, OH)

Los Angeles, California, United States

Los Angeles Hematology Oncology

Los Angeles, California, United States

University of Southern California Norris Comprehensive Cancer

Los Angeles, California, United States

Florida Cancer Specialists Pan Handle

Fort Myers, Florida, United States

Florida Cancer Specialists South

Fort Myers, Florida, United States

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

Miami, Florida, United States

Key Dates

Start Date

November 15, 2023

Primary Completion Date

July 31, 2027

Completion Date

July 31, 2029

Last Updated

June 21, 2024

Enrollment

756

ESTIMATED participants

Conditions

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

Interventions

Tifcemalimab injection

DRUG

toripalimab injection

DRUG

Placebo for Tifcemalimab

DRUG

Placebo for toripalimab

DRUG

Contacts

kui zhang, Project Directer

CONTACT

08618168028925 kui_zhang@junshipharma.com

Kinga Kovacs, Senior Project Leader

CONTACT

+ 31 6 45974346 Kinga.Kovacs@parexel.com