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

Henlius Pharmaceuticals

Status and phase: Enrolling; Phase 3

Conditions: Limited-Stage Small Cell Lung Cancer

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

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

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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:

Radiation: Thoracic radiotherapy

Drug: HLX10

Radiation: Prophylactic Cranial Irradiation (PCI)

Drug: carboplatin/cisplatin-etoposide

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:

Radiation: Thoracic radiotherapy

Radiation: Prophylactic Cranial Irradiation (PCI)

Drug: Placebo

Drug: carboplatin/cisplatin-etoposide