RecruitingPhase 2NCT06586697
First-line Treatment for ES-SCLC with Chemotherapy Combined with PD-1/PD-L1 Inhibitor Sequential Thoracic Radiotherapy
Sequential Thoracic Radiotherapy for Extensive-stage Small-cell Lung Cancer Treated with Chemo-immunotherapy Followed by PD-1/PD-L1 Inhibitor Maintenance Therapy：a Phase II, Single Arm, Prospective Trial
Sponsor
Henan Cancer Hospital
Enrollment
47 participants
Start Date
Dec 1, 2023
Study Type
INTERVENTIONAL
Conditions
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 cancer with chemotherapy combined with approved PD-1/PD-L1 inhibitors.
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria8
- 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 Criteria11
- 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.
Interventions
RADIATIONThoracic Radiotherapy
Thoracic Radiotherapy (45Gy /1.5Gy/bid/3w)
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06586697
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