Consolidative Thoracic Radiotherapy for Extensive-stage Small-cell Lung Cancer Treated with Chemo-immunotherapy Followed by PD-1/PD-L1 Maintenance Therapy:an Open Label, Single Arm Prospective Trial

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This is an open-label, single arm Phase II study designed to evaluate the efficacy and safety of thoracic radiotherapy for extensive-stage small-cell lung cancer treated with PD-1/PD-L1 plus etoposide platinum followed by PD-1/PD-L1 maintenance therapy

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Age between18 years and 80 years at time of study entry

• ECOG performance status of 0 or 1

• Body weight \>30 kg

• Adequate bone marrow, liver and kidney function

• Life expectancy of at least 3 months

• At least one measurable (RECIST 1.1), thoracic lesion that can be irradiated with 45 Gy/15 fractions

• Histologic or cytologic confirmation of small cell lung cancer

• Stage III-IV disease (TNM v8)

• Adequate pulmonary function with FEV1 \>1 L or \>30 % of predicted value and DLCO \>30 % of predicted value

⁃ Patients with brain metastases are eligible provided they are asymptomatic or treated and stable on steroids and/or anticonvulsants prior to the start of treatment -

Locations
Other Locations
China
Ruijin Hospital, Shanghai jiaotong univestigy school of medicine
RECRUITING
Shanghai
Time Frame
Start Date: 2021-01-30
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 104
Treatments
Experimental: experimental group
chemo-immunotherapy followed by thoracic radiotherapy and PD-1/PD-L1 maintenance therapy
Related Therapeutic Areas
Sponsors
Leads: Ruijin Hospital

This content was sourced from clinicaltrials.gov