Status:
NOT_YET_RECRUITING
An Exploratory Study of Lurbinectedin With Radiotherapy in Locally-advanced SCLC After First-line Therapy
Lead Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions:
Small Cell Lung Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This exploratory trial aims to determine if it is safe to use radiotherapy and lurbinectedin to treat locally-advanced SCLC after first-line therapy. This study will enroll patients with thoracic dise...
Detailed Description
PRIMARY OBJECTIVE: To describe the safety in terms of radiation therapy (RT) in combination with lurbinectedin in patients with locally-advanced SCLC after first-line therapy. SECONDARY OBJECTIVES: ...
Eligibility Criteria
Inclusion
- Has fully understood this study, voluntarily signed a written informed consent form, and is able to comply with the requirements and restrictions listed in the informed consent form;
- Age ≥ 18 years, Male/female participants;
- Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2;
- With pathologically confirmed diagnosis of Limited Stage SCLC(LS-SCLC),with local progression (mainly thoracic progression) after first-line chemotherapy with or without immunotherapy, but without distant metastasis; (Currently immunotherapy + chemotherapy is not the standard treatment for LS-SCLC);
- Has sufficient bone marrow, liver, kidney, and metabolic function, i.e., the functional levels of organs meet the following requirements:
- Platelets (PLT) ≥ 100×10\^9/L;
- Hemoglobin (Hb) ≥ 90 g/L;
- Absolute neutrophil (ANC) ≥ 2.0×10\^9/L;
- Regardless of whether liver metastasis is present, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0× upper limit of normal (ULN);
- Alkaline phosphatase (ALP) ≤ 5×ULN;
- Total bilirubin (TBIL) ≤ 1.5×ULN, and direct bilirubin ≤ 1.0×ULN;
- Serum creatinine ≤ 1.5×ULN or creatinine clearance rate ≥ 30 mL/min (calculated using the Cockcroft-Gault formula);
- Creatine phosphokinase (CPK) ≤ 2.5×ULN;
- Albumin ≥ 3.0 g/dL.
- A female of childbearing potential (FCBP) must have a negative serum pregnancy test prior to study entry. Woman of childbearing potential (WOCBP) must use adequate contraception during the test drug treatment period and for 6 months after the final dose. Male patients (with partners of WOCBP) must use adequate contraception for the duration of study participation, and 4 months after completion of administration.
Exclusion
- With concurrent brain metastasis, a history of spinal cord compression, or meningeal metastasis;
- With bone metastases;
- Patients with obstructive atelectasis, superior vena cava syndrome requiring surgical/ endoscopic/ interventional treatment; suspected or confirmed pulmonary embolism patients; those with uncontrollable large amounts of pleural effusion, ascites, or pericardial effusion;
- Patients known to be allergic to any component of the test drug;
- Pregnancy or breastfeeding or WOCBP who has a positive serum pregnancy test;
- Comorbidities Requirements:
- Has unstable angina, myocardial infarction, congestive heart failure (CHF) classified as New York Heart Association (NYHA) II or higher, or other clinically significant cardiovascular diseases currently or within the past year prior to screening;
- Patients with uncontrolled hypertension (systolic blood pressure greater than 160 mmHg and/or diastolic blood pressure greater than 100 mmHg), or a history of hypertensive crisis or hypertensive encephalopathy;
- Patients with severe arrhythmias requiring medication;
- Patients with active infections requiring systemic antibacterial, antifungal, or antiviral treatment within 2 weeks prior to administration;
- Patients with evidence of bleeding tendencies or coagulation disorders;
- Patients with other significant diseases judged unsuitable for entry by the investigator.
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT06501976
Start Date
July 1 2024
End Date
December 1 2025
Last Update
July 15 2024
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