Clinical trial NCT05552846: Phase II Trial of Consolidative Thoracic Radiotherapy for ES-SCLC After Standard Care of Chemo-immunotherapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Small-cell Lung Cancer
Keywords: thoradic radiotherapy
immune checkpoint inhibitors
chemo-immunotherapy
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2022-09-23
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

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 (determined as per the RECIST v1.1) after 6 cycle of platinum-based chemotherapy in combination with an anti-PD-1/L1. Then, those enrolled patients would be treated with thoracic radiotherapy concurrently with PD-1/PD-L1 maintenance therapy, and the total maintenance therapy time should at least more than 6 months.

Eligibility criteria: Inclusion Criteria:

1. Age between18 years and 80 years at time of study entry
2. ECOG performance status of 0 or 1
3. Body weight \>30 kg
4. Adequate bone marrow, liver and kidney function
5. Life expectancy of at least 3 months
6. At least one measurable (RECIST 1.1), thoracic lesion that can be irradiated with 45 Gy/15 fractions
7. Histologic or cytologic confirmation of small cell lung cancer
8. Stage III-IV disease (TNM v8)
9. Adequate pulmonary function with FEV1 \>1 L or \>30 % of predicted value and DLCO \>30 % of predicted value
10. 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 -

Exclusion Criteria:

1. Previous chemo-, immuno- or radiotherapy for SCLC
2. Major surgical procedure last 28 days
3. History of allogenic organ transplantation, autoimmune disease, immunodeficiency, hepatitis or HIV
4. Uncontrolled intercurrent illness
5. Other active malignancy
6. Leptomeningeal carcinomatosis
7. Immunosuppressive medication
8. Pregnant or breastfeeding women

Primary outcomes:
measure: 1-year progression-free survival
timeFrame: 12 months after last patient entry
Secondary outcomes:
measure: 1-year overall survival
timeFrame: 12 months after last patient entry
measure: toxicities
timeFrame: 12 months after last patient entry
measure: 5-year overall survival
timeFrame: 5-year after last patient entry
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai jiaotong univestigy school of medicine
state: Shanghai
Study officials:
References: