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    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2022-002226-27
    Sponsor's Protocol Code Number:HLX10-020-SCLC302
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-10-28
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2022-002226-27
    A.3Full title of the trial
    A Randomized, Double-Blind, International Multicenter, Phase III Study to Evaluate the Anti-Tumor Efficacy and Safety of HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) or Placebo in Combination with Chemotherapy (Carboplatin/Cisplatin-Etoposide) and Concurrent Radiotherapy in Patients with Limited-Stage Small Cell Lung Cancer (LS-SCLC)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase 3 study to Evaluate the Efficacy and Safety of HLX10 or placebo in Combination With Chemotherapy and Radiotherapy in Patients With Limited-Stage Small Cell Lung Cancer (LS-SCLC)
    A.4.1Sponsor's protocol code numberHLX10-020-SCLC302
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05353257
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation PlanP/471/2020
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorShanghai Henlius Biotech, Inc.
    B.1.3.4CountryChina
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportShanghai Henlius Biotech, Inc.
    B.4.2CountryChina
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationShanghai Henlius Biotech, Inc.
    B.5.2Functional name of contact pointSha Deng
    B.5.3 Address:
    B.5.3.1Street AddressRoom 330, Complex Building, No. 222, Kangnan Road, Pilot Free Trade Zone, PRC
    B.5.3.2Town/ cityShanghai
    B.5.3.3Post code200233
    B.5.3.4CountryChina
    B.5.4Telephone number+86 18510327602
    B.5.6E-mailSha_Deng@henlius.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameRecombinant humanized anti-PD-1 monoclonal antibody, or Serplulimab
    D.3.2Product code HLX10
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSerplulimab
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeHLX10
    D.3.9.3Other descriptive nameRecombinant humanized anti-PD-1 monoclonal antibody
    D.3.9.4EV Substance CodeSUB206488
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with Limited-Stage Small Cell Lung Cancer (LS-SCLC) at stage I-III of the AJCC 8th edition of the cancer staging
    E.1.1.1Medical condition in easily understood language
    Patients with limited-stage small cell lung cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10041067
    E.1.2Term Small cell lung cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the anti-tumor efficacy of HLX10 in combination with chemotherapy and concurrent radiotherapy in subjects with LS-SCLC.
    E.2.2Secondary objectives of the trial
    To evaluate the safety of HLX10 in combination with chemotherapy and concurrent
    radiotherapy in subjects with LS-SCLC.

    To evaluate the pharmacokinetics (PK), immunogenicity, and biomarkers
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients who voluntarily participate in this clinical study; fully understand and have been informed about the study and have signed the ICF; are willing to follow and able to complete all trial procedures.
    2. Male or female, aged ≥18 years when signing the ICF.
    3. Histologically diagnosed with SCLC.
    4. Diagnosed with LS-SCLC (stage 1-3 of the AJCC 8th edition of the cancer staging), which can be safely treated with curative radiation doses.
    5. With at least one measurable lesion as assessed by investigator as per RECIST v1.1 within 4 weeks prior to randomization.
    6. Patients must provide tumor tissues that meet the requirements for assay of PDL1 expression level. Patients are assessed for an evaluable PD-L1 expression category (negative: TPS < 1%, positive: TPS ≥ 1%, or not evaluable/not available) by the central laboratory.
    7. ECOG PS of 0 or 1.
    8. Expected survival of at least 6 months.
    9. Laboratory tests verified sufficient organ and marrow function, without serious abnormalities in haematopoietic function or cardiac, hepatic, or renal function, or immunodeficiency within 7 days prior to randomization.
    10. Female patients must meet one of the following conditions:
    a. Menopause (defined as no menstruation for at least 1 year with no confirmed cause other than menopause), or
    b. Surgically sterilized (removal of the ovaries and/or uterus), or
    c. Fertile, but must:
    o be tested negative for serum/urine pregnancy test within 7 days prior to the randomization, and
    o agree to use contraception methods with an annual failure rate of < 1% or to remain abstinent (avoid heterosexual intercourse from signing the ICF to at least 6 months after the last dose of the study drug) (a contraceptive method with an annual failure rate of <1% includes bilateral tubal ligation, male sterilization, correct use of hormonal contraceptives that can inhibit ovulation, hormone-releasing intrauterine devices and copper-containing intrauterine devices or condoms), and
    o not breastfeed
    11. Male patients must: agree to remain abstinent (avoid heterosexual intercourse) or take contraception measures as follows: male patients with a pregnant partner or a partner of childbearing potential must remain abstinent or use condoms to prevent drug exposure to the embryo during study treatment and for at least 6 months after the last dose of study drug. Periodic abstinence (e.g., contraception based on calendar day, ovulatory phase, basal body temperature, or postovulatory phase) and external ejaculation are ineligible methods of contraception.
    12. Previous non-systematic anti-tumor treatment should be completed ≥2 weeks prior to the initiation of study medication, and treatment related AEs have returned to ≤grade 1 based on Common Terminology Criteria for Adverse Events (CTCAE) 5.0 (except grade 2 hair loss).
    E.4Principal exclusion criteria
    1. Histologically or cytologically confirmed mixed SCLC.
    2. Subjects suitable for surgery. Subjects who are suitable for surgery but refuse surgical treatment can be included.
    3. Patients who have previously received systematic anti-tumor treatments for small cell lung cancer, including but not limited to radiotherapy, chemotherapy, and immunotherapy.
    4. Patients with other active malignancies within 5 years or at the same time. Localized tumors that have been cured such as basal cell carcinoma, squamouscell skin cancer, superficial bladder carcinoma, prostate carcinoma in situ, cervical carcinoma in situ, and breast cancer in situ are acceptable.
    5. Patients who are preparing for or have received an organ or bone marrow transplant.
    6. Patients with pleural, pericardial effusions, or ascites requiring clinical intervention.
    7. Patients with myocardial infarction and poorly controlled arrhythmia (including QTc intervals ≥ 470 ms) (QTc intervals are calculated by Fridericia's formula) within 6 months prior to the first dose of the investigational products.
    8. Class III to IV cardiac insufficiency according to NYHA classification or an left ventricular ejection fraction < 50% by cardiac color Doppler.
    9. Subject has uncontrolled or symptomatic hypercalcemia (> 1.5 mmol/L ionized calcium or calcium > 12 mg/dL or corrected serum calcium > ULN).
    10. Patients with peripheral neuropathy ≥ grade 2 by CTCAE.
    11. Patients with human immunodeficiency virus (HIV) infection, and HIV antibody test results are positive.
    12. Patients with active pulmonary tuberculosis.
    13. Subjects with previous and current interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, and severe impaired pulmonary function that may interfere with the detection and management of suspected drug-related pulmonary toxicity as judged by the investigator.
    14. With Hepatitis B (positive test for HBsAg or HBcAb and positive test for HBVDNA) or Hepatitis C (positive tests for HCV antibody and HCV-RNA). Subjects with a co-infection of hepatitis B and hepatitis C (tested positive for HBsAg or HBcAb, and positive for anti-HCV antibody).
    Note: Subjects with hepatitis B who are stable on antiviral therapy (HBV-DNA≤2500 copies/mL or 500IU/mL) can be enrolled.
    15. Subjects with known active or suspected autoimmune diseases. Subjects in a stable state with no need for systemic immunosuppressant therapy are allowed to be enrolled.
    16. Have received treatment with live vaccines within 28 days prior to the first administration. Subjects may receive inactivated viral vaccines for seasonal influenza, but may not receive live attenuated influenza vaccines via intranasal route.
    17. Subjects requiring treatment with systemic corticosteroids (> 10 mg/day therapeutic dose of prednisone) or other immunosuppressive drugs within 14 days prior to the first dose or during the study. However, subjects are allowed to be enrolled under the following conditions: in the absence of active autoimmune disease, subjects are allowed to use topical or inhaled glucocorticoids and ≤ 10
    mg/day therapeutic dose of prednisone for adrenal glucocorticoid replacement therapy.
    18. With any active infection requiring systemic anti-infective treatment within 14 days prior to the administration of the investigational product.
    19. Have received any major surgery (defined as surgeries requiring at least 3 weeks of recovery to be able to receive treatment in this study) within 28 days prior to the first dose of the investigational products.
    20. The subject has previously received other antibodies/drugs against immune checkpoints, such as PD-1, PD-L1, CTLA4, etc.
    21. Participation in any other ongoing interventional clinical studies, or less than 28 days from the end of the previous interventional clinical study treatment to the start of this trial.
    22. Subjects with known history of severe allergy to any monoclonal antibody.
    23. Subjects with known anaphylaxis to carboplatin/cisplatin or etoposide.
    24. Pregnant or lactating women.
    25. Subjects with a known history of psychotropics substance abuse or drug abuse.
    26. In the judgment of the investigator, subjects who have any other factors that may lead to a premature discontinuation.
    27. Subjects expected to require surgical resection during the study.
    28. Primary tumor/lymph node too large for planned radiotherapy.
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival (OS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Once every 12 weeks ± 7 days after the last dose of HLX10/placebo, until the withdrawal of informed consent, death, loss to follow-up, study discontinuation decided by the sponsor, or the end of study)
    E.5.2Secondary end point(s)
    -Progression-free survival (PFS, assessed by the investigator as per RECIST v1.1)
    - Objective response rate (ORR) (assessed by the investigator as per RECIST 1.1)
    - Duration of remission (DOR) (assessed by the investigator as per RECIST 1.1)
    - Adverse events (AE) (including serious adverse events (SAE)), laboratory tests (hematology, blood chemistry, coagulation function, urinalysis, thyroid function, and cardiac function), 12-lead electrocardiogram (12-lead ECG), vital signs, and physical examination
    - Quality of life assessment
    - Serum HLX10 concentration
    - HLX10 anti-drug antibody (ADA/NAb)
    - Relationship between PD-L1 expression in tumor tissuesand efficacy
    E.5.2.1Timepoint(s) of evaluation of this end point
    PFS-As assessed by the investigator as per RECIST v1.1, assessed when screening(within 4 weeks pre-dose), every 6 weeks (± 7 days) during the first 48 weeks after the start of study treatment, and every 9 weeks (± 7 days) after week 48.
    ORR-As assessed by the investigator as per RECIST v1.1.
    DOR-As assessed by the investigator as per RECIST v1.1.
    AEs-As assessed by the investigator during visit or informed by subject.
    Quality of life assessment-Once during screening period, once prior before the administration every 2 cycles until EOT visit.
    PK and ADA/NAb-within 7 days pre-dose in cycle1, within 3 days pre-dose in cycle2,4,6,8 and every 4 cycles thereafter, within 2 hours after the end of dosing in cycles 1 and 8 of treatment period(for PK only), at EOT visit and safety follow-up.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Hong Kong
    Australia
    China
    United States
    Austria
    Czechia
    Germany
    Greece
    Hungary
    Latvia
    Netherlands
    Poland
    Spain
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    End of study is defined as the moment when a target number of OS events (approximately 250) are observed and when the last subject has completed the safety follow-up visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 289
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 193
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 482
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After the end of study, the subjects will no longer receive study interventions.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-12-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-10-19
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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