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Trial record 1 of 1 for:    JS004-008
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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)

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ClinicalTrials.gov Identifier: NCT06095583
Recruitment Status : Recruiting
First Posted : October 23, 2023
Last Update Posted : May 13, 2024
Sponsor:
Information provided by (Responsible Party):
Shanghai Junshi Bioscience Co., Ltd.

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Limited-stage Small Cell Lung Cancer (LS-SCLC) Drug: Tifcemalimab injection Drug: toripalimab injection Drug: Placebo for Tifcemalimab Drug: Placebo for toripalimab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 756 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : November 15, 2023
Estimated Primary Completion Date : July 31, 2027
Estimated Study Completion Date : July 31, 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental group A
Tifcemalimab (200 mg intravenous infusion [IV]) and toripalimab (240 mg IV)
 Drug: Tifcemalimab injection
200mg once every 3weeks

Drug: toripalimab injection
240mg once every 3 weeks
Experimental: Experimental group B
Placebo for tifcemalimab (IV) and toripalimab (240 mg IV)
 Drug: toripalimab injection
240mg once every 3 weeks

Drug: Placebo for Tifcemalimab
every 3weeks
Placebo Comparator: Placebo group C
Placebos for both tifcemalimab and toripalimab (IV)
 Drug: Placebo for Tifcemalimab
every 3weeks

Drug: Placebo for toripalimab
every 3weeks


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: up to 3years ]
    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

  2. OS [ Time Frame: up to 3years ]
    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"

  3. Progression-free survival (PFS) [ Time Frame: up to 2years ]
    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.

  4. Progression-free survival (PFS) [ Time Frame: up to 2years ]
    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.


Secondary Outcome Measures :
  1. PFS [ Time Frame: up to 2years ]
    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

  2. 1-year OS rate [ Time Frame: up to 1year ]
    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

  3. 2-year OS rate [ Time Frame: up to 2 years ]
    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

  4. objective response rate (ORR) [ Time Frame: up to 2 years ]
    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

  5. disease control rate (DCR) [ Time Frame: up to 2 years ]
    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

  6. duration of response (DoR) [ Time Frame: up to 2years ]
    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

  7. PFS [ Time Frame: up to 2 years ]
    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

  8. 1 year OS rate [ Time Frame: up to 1 years ]
    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

  9. 2 year OS rate [ Time Frame: up to 2 years ]
    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

  10. ORR [ Time Frame: up to 2 years ]
    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

  11. DCR [ Time Frame: up to 2 years ]
    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

  12. DoR [ Time Frame: up to 2 years ]
    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

  13. safety [ Time Frame: up to 2 years ]
    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.

  14. safety [ Time Frame: up to 2 years ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06095583


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

Locations
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Sponsors and Collaborators
Shanghai Junshi Bioscience Co., Ltd.
More Information
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Responsible Party: Shanghai Junshi Bioscience Co., Ltd.
ClinicalTrials.gov Identifier: NCT06095583    
Other Study ID Numbers: JS004-008-III-SCLC
First Posted: October 23, 2023    Key Record Dates
Last Update Posted: May 13, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms