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A Study to Evaluate the Efficacy and Safety of Serplulimab in Combination With Chemotherapy and Concurrent Radiotherapy in Patients With Limited-Stage Small Cell Lung Cancer

H

Henlius Pharmaceuticals

Status and phase

Enrolling
Phase 3

Conditions

Limited-Stage Small Cell Lung Cancer

Treatments

Radiation: Thoracic radiotherapy
Drug: carboplatin/cisplatin-etoposide
Radiation: Prophylactic Cranial Irradiation (PCI)
Drug: Placebo
Drug: HLX10

Study type

Interventional

Funder types

Industry

Identifiers

NCT05353257
HLX10-020-SCLC302

Details and patient eligibility

About

This study is a randomized, double-blind, multicenter, phase III clinical study to compare the clinical efficacy and safety of Serplulimab + chemotherapy+ concurrent radiotherapy vs chemotherapy+ concurrent radiotherapy in subjects with Limited-Stage Small Cell Lung Cancer.

Full description

Eligible subjects in this study will be randomized to Arm A or Arm B at 1:1 ratio.

Arm A (Serplulimab arm): Serplulimab + chemotherapy(Carboplatin/Cisplatin-Etoposide)+concurrent radiotherapy; Arm B (placebo arm): Placebo + chemotherapy(Carboplatin/Cisplatin-Etoposide)+concurrent radiotherapy; The 4 stratification factors for randomization include: ECOG PS (0 or 1), staging (I/II or III), radiation fraction (bid or qd), and region (Asia or non-Asia).

Enrollment

482 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Male or female, aged ≥18 years when signing the ICF.
  2. Histologically diagnosed with SCLC.
  3. Diagnosed with LS-SCLC (stage Ⅰ-Ⅲ of the AJCC 8th edition of the cancer staging), which can be safely treated with curative radiation doses.
  4. Major organs are functioning well.

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.
  5. Subjects with known history of severe allergy to any monoclonal antibody.
  6. Subjects with known anaphylaxis to carboplatin/cisplatin or etoposide.
  7. In the judgment of the investigator, subjects who have any other factors that may lead to a premature discontinuation.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

482 participants in 2 patient groups, including a placebo group

Serplulimab + carboplatin/cisplatin-etoposide + radiotherapy
Experimental group
Description:
Participants will receive 4 cycles of standard-of-care chemotherapy (carboplatin/cisplatin-etoposide) plus Serplulimab 300 mg every 3 weeks (Q3W) concurrently with standard thoracic radiotherapy, with maximum 1 year after completion of cCRT or until disease progression, intolerable toxicity or other reasons specified in the protocol, whichever occurs first.
Treatment:
Drug: HLX10
Radiation: Prophylactic Cranial Irradiation (PCI)
Drug: carboplatin/cisplatin-etoposide
Radiation: Thoracic radiotherapy
placebo + carboplatin/cisplatin-etoposide + radiotherapy
Placebo Comparator group
Description:
Participants will receive 4 cycles of standard-of-care chemotherapy (carboplatin/cisplatin-etoposide) plus placebo every 3 weeks (Q3W) concurrently with standard thoracic radiotherapy, with maximum 1 year after completion of cCRT or until disease progression, intolerable toxicity or other reasons specified in the protocol, whichever occurs first.
Treatment:
Drug: Placebo
Radiation: Prophylactic Cranial Irradiation (PCI)
Drug: carboplatin/cisplatin-etoposide
Radiation: Thoracic radiotherapy

Trial contacts and locations

129

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Central trial contact

Ying Cheng; Jinming Yu, MD

Data sourced from clinicaltrials.gov

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