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Trial Title:
First-line Treatment for ES-SCLC with Chemotherapy Combined with PD-1/PD-L1 Inhibitor Sequential Thoracic Radiotherapy
NCT ID:
NCT06586697
Condition:
Extensive-stage Small-cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Thoracic Radiotherapy
Description:
Thoracic Radiotherapy (45Gy /1.5Gy/bid/3w)
Arm group label:
Thoracic Radiotherapy
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.
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-1/PD-L1 inhibitors. Then, those enrolled patients would be
treated with thoracic radiotherapy concurrently with PD-1/PD-L1 maintenance therapy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age between18 years and 75 years.
2. Histologic or cytologic confirmation of extensive-stage small cell lung cancer.
3. Initially treated patients with extensive SCLC showed no disease progression after
4-6 cycles of chemotherapy combined with PD-1/PD-L1 inhibitors.
4. Presence of at least one measurable lesion (according to RECIST v1.1).
5. ECOG performance status of 0 or 1.
6. Life expectancy of at least 3 months.
7. Adequate bone marrow, liver and kidney function.
8. Adequate pulmonary function with FEV1 >1 L or >30 % of predicted value and DLCO >30
% of predicted value
Exclusion Criteria:
1. Previous T cell co-stimulation or immune checkpoint therapy.
2. Previous received chemoradiotherapy for limited-stage SCLC.
3. Central nervous system metastasis with clinical symptoms.
4. Multiple liver metastases (patients with isolated liver metastases, metastatic
lesions < 3cm could be included).
5. Patients with spinal cord compression.
6. 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).
7. Have received any other investigational drug treatment or participated in another
interventional clinical study within 4 weeks prior to signing the informed consent.
8. In the 5 years prior to the study, subjects had prior or concurrent malignancies
requiring active treatment.
9. Subjects with any severe and/or uncontrolled disease (hypertension, heart disease,
infection, cirrhosis, active hepatitis, AIDS, third space effusion).
10. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem
cell transplantation.
11. Severe allergic reactions to any of the monoclonal antibodies are known to occur.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
HenanCH
Address:
City:
Zhengzhou
Zip:
450000
Country:
China
Status:
Recruiting
Contact:
Last name:
yang liu
Phone:
13676961186
Email:
zlyyliuyang1440@zzu.edu.cn
Start date:
December 1, 2023
Completion date:
March 20, 2026
Lead sponsor:
Agency:
Henan Cancer Hospital
Agency class:
Other
Source:
Henan Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06586697
