RECRUITING

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)

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Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-11-15
Study Completion:2029-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06095583

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male or female with age ≥ 18 years old at the time of informed consent.
  2. 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. 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. 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. 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1 .
  6. 6. Adequate organ function
  7. 7. Female patients of childbearing potential and male patients whose partners are women of childbearing age.
  8. 8. Voluntarily agree to participate in the study, sign the informed consent form, and agree to comply with all study and follow-up procedures.
  1. 1. Mixed SCLC and non-small cell lung cancer (NSCLC).
  2. 2. Received sequential chemoradiotherapy for LS-SCLC.
  3. 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. 4. Patients with active autoimmune disease, history of autoimmune disease.
  5. 5. History of immunodeficiency, including HIV seropositivity, other acquired congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation.
  6. 6. History of confirmed or suspected interstitial lung disease or pneumonitis (except for Grade 1 radiation pneumonitis not treated with corticosteroids).
  7. 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. 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. 9. Women who are pregnant or breastfeeding.

Contacts and Locations

Study Contact

kui zhang, Project Directer
CONTACT
08618168028925
kui_zhang@junshipharma.com
Kinga Kovacs, Senior Project Leader
CONTACT
+ 31 6 45974346
Kinga.Kovacs@parexel.com

Study Locations (Sites)

Banner MD Anderson Cancer Center
Goodyear, Arizona, 85338
United States
Banner University Medical Center
Tucson, Arizona, 85713
United States
Genesis Cancer and Blood Institute (Hot Springs, AR)
Hot Springs, Arkansas, 05001
United States
SCRI Nashville
Davis, California, 95616
United States
Zangmeister Cancer Center (Columbus, OH)
Los Angeles, California, 43219
United States
Los Angeles Hematology Oncology
Los Angeles, California, 90033
United States
University of Southern California Norris Comprehensive Cancer
Los Angeles, California, 90033
United States
Florida Cancer Specialists Pan Handle
Fort Myers, Florida, 32310
United States
Florida Cancer Specialists South
Fort Myers, Florida, 33908
United States
USA029 University of Miami Sylvester Comprehensive Cancer Center 1550 NW 10th Avenue 33173 Miami FL Ikpeazu Chukwuemeka N
Miami, Florida, 33173
United States
Mid-Florida Hematology Oncology
Orange City, Florida, 55905
United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Marietta, Georgia, 30060
United States
Norton Cancer Institute, Downtown, Multidisciplinary Clinic
Louisville, Kentucky, 40241
United States
American Oncology Partners of Maryland, PA
Bethesda, Maryland, 20817
United States
Dana Farber Cancer Institute-Hematology/Oncology
Boston, Massachusetts, 461099
United States
Karmanos Cancer Center
Detroit, Michigan, 48201
United States
Henry Ford Health System
Detroit, Michigan, 48202
United States
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan, 49502
United States
Washington University School of Medicine - Siteman Cancer Center
Saint Louis, Missouri, 63101
United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 07101
United States
North Shore Hematology Oncology Associates DBA NY Cancer and Blood Specialists
New York, New York, 11776
United States
University of Stony Brook
Stony Brook, New York, 11794
United States
Toledo Clinic Cancer Center - Toledo
Toledo, Ohio, 97391
United States
Oncology Associates Of Oregon, P.C.
Eugene, Oregon, 97401
United States
Oregon Health and Science University
Portland, Oregon, 97239
United States
Millennium Physicians - Oncology
Houston, Texas, 77090
United States
Texas Oncology, P.A. - Oncology
Tyler, Texas, 97402
United States
Virginia Cancer Specialists
Fairfax, Virginia, 22030
United States

Collaborators and Investigators

Sponsor: Shanghai Junshi Bioscience Co., Ltd.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-15
Study Completion Date2029-07-31

Study Record Updates

Study Start Date2023-11-15
Study Completion Date2029-07-31

Terms related to this study

Additional Relevant MeSH Terms

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