Lung Cancer Clinical Trial

A Study to Evaluate the Efficacy and Safety of HLX10 in Combination With Chemotherapy and Concurrent Radiotherapy in Patients With Limited-Stage Small Cell Lung Cancer

Summary

This study is a randomized, double-blind, multicenter, phase III clinical study to compare the clinical efficacy and safety of HLX10 + chemotherapy+ concurrent radiotherapy vs chemotherapy+ concurrent radiotherapy in subjects with Limited-Stage Small Cell Lung Cancer.

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Full Description

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

Arm A (HLX10 arm): HLX10 + 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).

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Eligibility Criteria

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.

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

482

Study ID:

NCT05353257

Recruitment Status:

Recruiting

Sponsor:

Shanghai Henlius Biotech

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There are 3 Locations for this study

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Research Site
Orange California, 32763, United States More Info
Study Coordinator
Contact
Research Site
Santa Rosa California, 95403, United States More Info
Study Coordinator
Contact
Shandong Cancer Hospital
Jinan Shandong, 25011, China More Info
Jinming Yu, PhD
Contact
13806406293
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

482

Study ID:

NCT05353257

Recruitment Status:

Recruiting

Sponsor:


Shanghai Henlius Biotech

How clear is this clinincal trial information?

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