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RecruitingLast updated: 19 April 2024

HLX10: This study is comparing the effectiveness of chemotherapy and radiation therapy when given with or without a new targeted therapy (HLX10) in people with limited-stage small cell lung cancerA Randomized, Double-Blind, International Multicenter, Phase III Study to Evaluate the Anti-Tumor Efficacy and Safety of HLX10 or Placebo in Combination With Chemotherapy and Concurrent Radiotherapy in Patients With Limited-Stage Small Cell Lung Cancer

Clinical summary

Summary

Eligible participants will be randomly allocated to either the Experimental Arm or the Placebo Comparator Arm. All participants will receive active treatment. In the Experimental Arm, participants will receive 4 cycles of standard-of-care chemotherapy (carboplatin/cisplatin-etoposide) plus HLX10 (300mg) every three weeks, at the same time as receiving standard thoracic radiation therapy. In the Placebo Comparator Arm, participants will receive 4 cycles of standard-of-care chemotherapy (carboplatin/cisplatin-etoposide) plus a placebo every 3 weeks, at the same time as receiving thoracic radiation therapy.

Conditions

This trial is treating patients with small cell lung cancer

Cancer

Lung Cancers Lung cancer

Age

People18+

Phase

III

Trial Acronym

HLX10

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Trial Identifiers

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Trial sponsor

Shanghai Henlius Biotech

Scientific Title

A Randomized, Double-Blind, International Multicenter, Phase III Study to Evaluate the Anti-Tumor Efficacy and Safety of HLX10 or Placebo in Combination With Chemotherapy and Concurrent Radiotherapy in Patients With Limited-Stage Small Cell Lung Cancer

Eligibility

Inclusion

  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

  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.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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