Status:
RECRUITING
First-line Treatment for ES-SCLC with Chemotherapy Combined with PD-1/PD-L1 Inhibitor Sequential Thoracic Radiotherapy
Lead Sponsor:
Henan Cancer Hospital
Conditions:
Extensive-stage Small-cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is an open-label, single arm Phase II study designed to observe and evaluate the efficacy and safety of sequential thoracic radiotherapy in the first-line treatment of extensive small cell lung c...
Detailed Description
This study a single arm prospective phase II study. All the enrolled patients will be patients with ES-SCLC who did not have PD after 4-6 cycle of platinum-based chemotherapy in combination with an PD...
Eligibility Criteria
Inclusion
- Age between18 years and 75 years.
- Histologic or cytologic confirmation of extensive-stage small cell lung cancer.
- Initially treated patients with extensive SCLC showed no disease progression after 4-6 cycles of chemotherapy combined with PD-1/PD-L1 inhibitors.
- Presence of at least one measurable lesion (according to RECIST v1.1).
- ECOG performance status of 0 or 1.
- Life expectancy of at least 3 months.
- Adequate bone marrow, liver and kidney function.
- Adequate pulmonary function with FEV1 \>1 L or \>30 % of predicted value and DLCO \>30 % of predicted value
Exclusion
- Previous T cell co-stimulation or immune checkpoint therapy.
- Previous received chemoradiotherapy for limited-stage SCLC.
- Central nervous system metastasis with clinical symptoms.
- Multiple liver metastases (patients with isolated liver metastases, metastatic lesions \< 3cm could be included).
- Patients with spinal cord compression.
- Idiopathic pulmonary fibrosis, institutional pneumonia, drug-induced pneumonia or idiopathic pneumonia, or evidence of active pneumonia during screening (patients with active pulmonary tuberculosis couldn't be enrolled).
- Have received any other investigational drug treatment or participated in another interventional clinical study within 4 weeks prior to signing the informed consent.
- In the 5 years prior to the study, subjects had prior or concurrent malignancies requiring active treatment.
- Subjects with any severe and/or uncontrolled disease (hypertension, heart disease, infection, cirrhosis, active hepatitis, AIDS, third space effusion).
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Severe allergic reactions to any of the monoclonal antibodies are known to occur.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 20 2026
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT06586697
Start Date
December 1 2023
End Date
March 20 2026
Last Update
September 19 2024
Active Locations (1)
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1
HenanCH
Zhengzhou, Henan, China, 450000