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Clinical Trials List

Protocol NumberJS004-008-III-SCLC
Active

2024-01-22 - 2027-05-27

Phase III

Not yet recruiting1

Recruiting11

ICD-10C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

ICD-10C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

ICD-10C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

ICD-10C7A.090

Malignant carcinoid tumor of the bronchus and lung

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

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

  • Trial Applicant

    PAREXEL INTERNATIONAL CO., LTD.

  • Sponsor

    Shanghai Junshi Biosciences Co., Ltd.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Shih-Hsin Hsiao Division of Thoracic Medicine
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator CHIN-CHOU WANG Division of Thoracic Medicine
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Han-Lin Hsu Division of Thoracic Medicine
Taipei WanFang Hospital (Managed by Taipei Medical Univeristy)

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator James Chih-Hsin Yang Division of Hematology & Oncology
National Taiwan University Cancer Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 高婉真 Division of Hematology & Oncology
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chun-Hui Lee Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chien-Ying Liu Division of Thoracic Medicine
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Te-Chun Hsia Division of General Internal Medicine
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator James Chih-Hsin Yang Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator kang-Yun LEE
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator TSUNG -YING YANG Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Limited-Stage Small Cell Lung Cancer Without Disease Progression Following Chemoradiotherapy

Objectives

Primary Objectives: • To compare and evaluate the efficacy of tifcemalimab combined with toripalimab (Group A) versus placebo (Group C) as consolidation therapy after chemoradiotherapy (CRT) in patients with LS-SCLC, assessed by overall survival (OS) and progression-free survival (PFS) as assessed by a blinded independent committee (BIRC). • To compare and evaluate the efficacy of toripalimab (Group B) versus placebo (Group C) as consolidation therapy after CRT in patients with LS-SCLC, assessed by OS and PFS as assessed by BIRC. Secondary Objectives: • To compare and evaluate the efficacy of tifcemalimab combined with toripalimab (Group A) versus placebo (Group C) as consolidation therapy after CRT in patients with LS-SCLC, assessed by PFS as assessed by the trial administrator, 1-year and 2-year OS rates, objective response rate (ORR), disease control rate (DCR), and duration of response (DoR). • Compare and evaluate the efficacy of toripalimab (Group B) compared to placebo (Group C) as consolidation therapy after CRT in patients with LS-SCLC, based on investigator-assessed PFS, 1-year and 2-year OS rates, ORR, DCR, and DoR. • Compare and evaluate the safety of tifcemalimab in combination with toripalimab (Group A) compared to placebo (Group C) as consolidation therapy after CRT in patients with LS-SCLC, based on adverse event incidence and abnormal laboratory parameters. • Compare and evaluate the safety of toripalimab (Group B) compared to placebo (Group C) as consolidation therapy after CRT in patients with LS-SCLC, based on adverse event incidence and abnormal laboratory parameters. • Investigate the pharmacokinetics (PK) of tifcemalimab and toripalimab. • Assess the immunogenicity profile of tifcemalimab and toripalimab, and evaluate the impact of immunogenicity on PK, safety, and efficacy (if data permit). Exploratory Purposes • To assess the correlation between biomarkers and therapeutic efficacy.

Test Drug

injection

Active Ingredient

Tifcemalimab
Toripalimab

Dosage Form

246
246

Dosage

--

Endpoints

OS.

Inclution Criteria

Patients must meet all of the following inclusion criteria to be eligible for inclusion:

1. Male or female aged ≥ 18 years at the time of providing informed consent.

2. Histologically/cytologically confirmed limited-stage (TNM stage I-III [Any T stage, Any N stage, M0] according to AJCC 8th edition) SCLC, who can safely receive a determined dose of radiation therapy. Patients with stage I or II disease must be unable to undergo surgical intervention (at the discretion of the trial administrator) or must refuse surgery. 3. Prior CRT treatment is defined as: (1) four cycles of chemotherapy including carboplatin or cisplatin and intravenous etoposide; (2) a standard once-daily (QD) radiotherapy regimen with a total radiation dose of 60-70 Gy, or a twice-daily (BID) high-fractionation radiotherapy regimen with a total radiation dose of 45 Gy; (3) the patient must begin the trial intervention within 42 days of the last dose of chemotherapy or radiotherapy (based on the last dose).

4. After receiving curative platinum-based CRT, the patient must achieve a complete response (CR), partial response (PR), or stable disease (SD), and must not progress to disease progression (PD) before entering the trial.

5. Prophylactic cranial radiation therapy (PCI) is permitted based on the trial administrator's judgment and local care standards. PCI may be performed before or during the trial. 6. Approximately five unstained, formalin-fixed, paraffin-embedded serial sections of tumor tissue (preferably freshly obtained) should be provided for biomarker analysis prior to radiotherapy. Patients unable to provide sufficient tumor tissue samples as described above will only be included after discussion and agreement between the trial administrator and the trial sponsor.

7. East Coast Cancer Clinical Research Consortium (ECOG) Performance Status (PS) score of 0-1.

8. Mean life expectancy ≥ 12 weeks.

9. Adequate organ function is defined as follows (Note: No blood component transfusions or hematopoietic growth factors are permitted within 14 days prior to obtaining screening test results):

a. Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L;

b. Platelet count ≥ 100 x 10^9/L;

c. Heme ≥ 9 g/dL;

d. Bilirubin ≤ 1.5 times the upper limit of normal (ULN), alanine transaminase (ALT) ≤ 2.5 times the ULN, aspartate transaminase (AST) ≤ 2.5 times the ULN;

e. Creatinine clearance calculated according to the Cockcroft-Gault formula ≥ 30 mL/min;

f. Activated partial thromboplastin time (aPTT)/partial thromboplastin time (PTT) ≤ 1.5 times the ULN and International Standard Ratio (INR) ≤ 1.5. Patients receiving stable doses of anticoagulant therapy (such as low molecular weight heparin or warfarin) are excluded (as long as their INR falls within the expected range of anticoagulant therapy).

10. Female patients of childbearing potential and male patients whose partners are women of childbearing age must use highly effective contraception during the trial treatment period and for at least 4 months after the last dose of tifcemalimab/placebo or toripalimab/placebo.

11. Voluntary consent to participate in this trial, signing of the subject consent form, and agreement to comply with all trial and follow-up procedures.

Exclusion Criteria

Patients meeting any of the following criteria will be ineligible for participation in this trial:

1. Mixed-type SCLC and non-small cell lung cancer (NSCLC).

2. Received more than or less than 4 cycles of chemotherapy during CRT, or previously received intravenous etoposide or chemotherapy regimens other than platinum-based regimens.

3. Previously received sequential chemoradiotherapy for LS-SCLC.

4. Known hypersensitivity or allergic reaction to any of the experimental interventions or any of the excipients used in the experimental interventions.

5. Have received any of the following treatments:

a. Immunotransmitter therapy, including but not limited to antiprogrammed cell death protein-1 (PD-1), antiprogrammed cell death-ligand 1 (PD-L1), or anticytotoxic T-lymphocyte-associated protein 4 (CTLA-4) therapy.

b. Received any investigational drug within 4 weeks prior to the first dose or within 5 half-lives (whichever is shorter).

c. Enrollment in another clinical trial concurrently, unless it is an observational (non-invasive) clinical trial or the patient is in the follow-up period of an invasive clinical trial.

d. Use of systemic corticosteroids > 10 mg/day prednisone or its equivalent or other immunosuppressants within 2 weeks prior to the first dose of the trial intervention. Inhaled or topical corticosteroids are permitted. Short-course use of corticosteroids (e.g., before intravenous contrast agents) is permitted within 2 weeks after the first dose of the trial intervention.

e. Received an anti-tumor vaccine or live vaccine within 4 weeks prior to the first dose of the trial intervention.

f. Underwent major surgery or suffered severe trauma within 4 weeks prior to the first dose of the trial intervention.

6. Failure to recover from the toxicity of previous anticancer therapy to a Commonly Used Criteria for Adverse Events (CTCAE) grade ≤ 1 (excluding hair loss) or a grade listed in the inclusion/exclusion criteria, whichever is more severe.

7. Patients with active autoimmune diseases or a history of autoimmune diseases (including but not limited to interstitial pneumonia, colitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, or hypothyroidism). Patients with vitiligo or childhood asthma/allergies who do not require any interventional treatment in adulthood, patients receiving stable-dose thyroid hormone replacement therapy for autoimmune-mediated hypothyroidism, and patients receiving stable-dose insulin therapy for type 1 diabetes are eligible for inclusion.

8. Patients with a history of immunodeficiency, including a positive serological test for human immunodeficiency virus (HIV), other acquired/congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation.

9. Within 4 weeks prior to the first dose of trial intervention, the patient had a severe or life-threatening infection (CTCAE grade > 2), such as severe pneumonia, bacteremia, or infectious complications requiring hospitalization; a baseline chest imaging showing suspected open lung inflammation; or within 2 weeks prior to the first dose of trial intervention, the patient had signs and symptoms requiring oral or intravenous antibiotic therapy (excluding prophylactic antibiotics).

10. A history of confirmed or suspected interstitial lung disease or pneumonia (excluding Grade 1 radiation pneumonitis not treated with corticosteroids).

11. Patients with confirmed open tuberculosis based on medical history or computed tomography (CT) examination; patients with a history of treated open tuberculosis within the past year; or patients with a history of untreated open tuberculosis more than one year prior to enrollment.

12. Active hepatitis B (HBV DNA ≥ 500 IU/mL) or hepatitis C (positive hepatitis C antibody and HCV RNA above the analytical method's detection limit).

13. Any other diagnosed malignancy prior to the first dose of trial intervention, except for those with a very low risk of metastasis (5-year survival > 90%), such as well-treated basal cell carcinoma or squamous cell carcinoma of the skin, cervical carcinoma in situ or breast cancer, or well-treated localized prostate cancer.

14. Currently pregnant or breastfeeding.

15. Uncontrolled comorbidities, including but not limited to symptomatic congestive heart failure, left ventricular ejection ratio (LVEF) < 50%, uncontrolled hypertension, unstable angina, uncontrolled arrhythmia, severe chronic gastrointestinal disease with diarrhea, or mental/social conditions that may affect trial compliance, significantly increasing the risk of adverse events (AEs) or affecting the patient's ability to provide written consent.

16. Patients with other conditions that, in the assessment of the trial administrator, may lead to early withdrawal from the trial, such as other serious illnesses requiring concurrent therapy (including mental illness), serious abnormal laboratory test results, and/or family or social factors that may jeopardize patient safety or information collection.

The Estimated Number of Participants

  • Taiwan

    38 participants

  • Global

    756 participants

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