Last updated: May 4, 2024
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Overall Status: Active - Recruiting
Phase
2
Condition
Small Cell Lung Cancer
Treatment
hypofractionated radiotherapy
Prophylactic Cranial Irradiation (PCI)
HLX10
Clinical Study ID
NCT05443646
ASTRUM-LC01
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age 18-75 years; ECOG score 0-1.
- Histologically or cytologically confirmed small cell lung cancer.
- Limited stage, defined as the tumor confined to one side of the thoracic cavityincluding ipsilateral hilar, bilateral mediastinal, and bilateral supraclavicularlymph nodes, (metastatic lymph nodes are defined as short diameter ≥ 1 cm or increasedmetabolism on PET-CT considering metastatic lymph nodes); unless cytologicallyconfirmed malignant pleural effusion, the thickness of pleural effusion on chest CT isless than 1 cm; (stage I-IIIB without intrapulmonary metastasis in the 7th edition ofAJCC staging in 2009) .
- No other previous anti-tumor history, at least 3 months of expected survival.
- No serious medical diseases and dysfunction of major organs, such as blood routine,liver, kidney, heart and lung function.
Exclusion
Exclusion Criteria:
- Histologically or cytologically confirmed mixed SCLC.
- Subjects suitable for surgery. Subjects who are suitable for surgery but refusesurgical treatment can be included.
- Patients who have previously received systematic anti-tumor treatments for small celllung cancer, including but not limited to radiotherapy, chemotherapy, andimmunotherapy.
- 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 leadto a premature discontinuation.
Study Design
Total Participants: 55
Treatment Group(s): 3
Primary Treatment: hypofractionated radiotherapy
Phase: 2
Study Start date:
September 23, 2022
Estimated Completion Date:
June 30, 2025
Study Description
Connect with a study center
Jiamusi Cancer Hospital
Jiamusi, Heilongjiang 154007
ChinaActive - Recruiting
Shanxi Province Cancer Hospital
Taiyuan, Shanxi 030013
ChinaActive - Recruiting
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