Lung Cancer Clinical Trial

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)

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion 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 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.
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.
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.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1 .
Adequate organ function
Female patients of childbearing potential and male patients whose partners are women of childbearing age.
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.

Mixed SCLC and non-small cell lung cancer (NSCLC).
Received sequential chemoradiotherapy for LS-SCLC.
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.
Patients with active autoimmune disease, history of autoimmune disease.
History of immunodeficiency, including HIV seropositivity, other acquired congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation.
History of confirmed or suspected interstitial lung disease or pneumonitis (except for Grade 1 radiation pneumonitis not treated with corticosteroids).
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).
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.
Women who are pregnant or breastfeeding.

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

756

Study ID:

NCT06095583

Recruitment Status:

Recruiting

Sponsor:

Shanghai Junshi Bioscience Co., Ltd.

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There are 28 Locations for this study

See Locations Near You

Banner MD Anderson Cancer Center
Goodyear Arizona, 85338, United States More Info
Jiaxin Niu
Contact
Banner University Medical Center
Tucson Arizona, 85713, United States More Info
Charles Hsu
Contact
Genesis Cancer and Blood Institute (Hot Springs, AR)
Hot Springs Arkansas, 05001, United States More Info
Roy Timothy Webb
Contact
SCRI Nashville
Davis California, 95616, United States More Info
Jhonson Melissa
Contact
Zangmeister Cancer Center (Columbus, OH)
Los Angeles California, 43219, United States More Info
Jorge Rios-Perez
Contact
Los Angeles Hematology Oncology
Los Angeles California, 90033, United States More Info
Lasika Seneviratne,
Contact
University of Southern California Norris Comprehensive Cancer
Los Angeles California, 90033, United States More Info
Robert Hsu,
Contact
Florida Cancer Specialists Pan Handle
Fort Myers Florida, 32310, United States More Info
Jeffrey Bubis
Contact
Florida Cancer Specialists South
Fort Myers Florida, 33908, United States More Info
Alexander Glick
Contact
USA029 University of Miami Sylvester Comprehensive Cancer Center 1550 NW 10th Avenue 33173 Miami FL Ikpeazu Chukwuemeka N
Miami Florida, 33173, United States More Info
Ikpeazu Chukwuemeka
Contact
Mid-Florida Hematology Oncology
Orange City Florida, 55905, United States More Info
Santosh Nair
Contact
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Marietta Georgia, 30060, United States More Info
Steven McCune,
Contact
Norton Cancer Institute, Downtown, Multidisciplinary Clinic
Louisville Kentucky, 40241, United States More Info
Lye Adam
Contact
American Oncology Partners of Maryland, PA
Bethesda Maryland, 20817, United States More Info
Boccia Ralph
Contact
Dana Farber Cancer Institute-Hematology/Oncology
Boston Massachusetts, 46109, United States More Info
Jacob Sands
Contact

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

756

Study ID:

NCT06095583

Recruitment Status:

Recruiting

Sponsor:


Shanghai Junshi Bioscience Co., Ltd.

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