Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05353257

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Limited-Stage Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Klinikum Klagenfurt am Worthersee, Klagenfurt, Austria

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female, aged ≥18 years when signing the ICF.
  • Histologically diagnosed with SCLC.
  • 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.
  • Major organs are functioning well.

Exclusion criteria

  • Histologically or cytologically confirmed mixed SCLC.
  • Subjects suitable for surgery. Subjects who are suitable for surgery but refuse surgical treatment can be included.
  • Patients who have previously received systematic anti-tumor treatments for small cell lung cancer, including but not limited to radiotherapy, chemotherapy, and immunotherapy.
  • Patients with other active malignancies within 5 years or at the same time.
  • Subjects with known history of severe allergy to any monoclonal antibody.
  • Subjects with known anaphylaxis to carboplatin/cisplatin or etoposide.
  • In the judgment of the investigator, subjects who have any other factors that may lead to a premature discontinuation.

Treatment and study plan

HLX10

Drug

Serplulimab is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc.

300mg Q3W

Other names: Serplulimab

carboplatin/cisplatin-etoposide

Drug

Etoposide: 100 mg/m2, IV, on Days 1, 2, and 3 of each cycle. Carboplatin: AUC = 5, IV, on Day 1 of each cycle up to a dose of 750 mg. investigator's choice.

Cisplatin: 75mg/m2, IV, on Days 1 of each cycle. investigator's choice.

thoracic radiotherapy

Radiation

Standard Thoracic Radiotherapy

Placebo

Drug

Placebo Q3W

prophylactic cranial irradiation (PCI)

Radiation

PCI will be strongly recommended for participants who achieve CR or PR after completion of chemoradiation treatment.

Primary outcomes

  1. Progression-free survival (PFS)

    Time frame: up to approximately 24months

    PFS, assessed by the Blinded Independent Central Review (BICR) as per RECIST v1.1

  2. Overall survival (OS)

    Time frame: up to 36 months

    the time from randomization to death due to any cause

Secondary outcomes

  1. Progression-free survival

    Time frame: up to approximately 24months

    PFS, assessed by the investigator as per RECIST v1.1

  2. Objective response rate (ORR)

    Time frame: up to approximately 24months

    ORR, assessed by the BICR and investigator as per RECIST 1.1

  3. Duration of remission (DOR)

    Time frame: up to approximately 24months

    DOR, assessed by the BICR and investigator as per RECIST 1.1

Sponsors and collaborators

Lead sponsor

Shanghai Henlius Biotech

Industry

Registry information

Official study title

A Randomized, Double-Blind, International Multicenter, Phase III Study to Evaluate the Anti-Tumor Efficacy and Safety of Serplulimab or Placebo in Combination With Chemotherapy and Concurrent Radiotherapy in Patients With Limited-Stage Small Cell Lung Cancer

Important dates

Study start
2022
Primary completion
2026
Study completion
2028
First posted
Apr 29, 2022
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.