Phase II Trial of Consolidative Thoracic Radiotherapy for ES-SCLC After Standard Care of Chemo-immunotherapy

Small-cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05552846
• Other study ID #: 2021(212)
• Status: Recruiting
• Phase: Phase 2
• Start date: September 30, 2022
• Est. completion date: September 30, 2026

Study information

• Verified date: September 2022
• Source: Ruijin Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 4 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: September 30, 2026
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Carcinoma
• Small-cell Lung Cancer

Intervention

Radiation:
• thoracic radiotherapy
Four courses of carboplatin/etoposide/anti-PD-1/PD-L1 every 3 weeks All the enrolled patients will be patients with ES-SCLC who did not have PD (determined as per the RECIST v1.1) after 4 cycle of platinum-based chemotherapy in combination with an anti-PD-1/L1. Then, thoracic radiotherapy of 45 Gy/15 fractions. PD-1/PD-L1 maintenance therapy concurrently and after thoracic radiotherapy at least more than 6 months, or until intolerable toxicity, progressive disease leading to a need for other treatment, or until the patient no longer wishes to continue treatment.

Locations

Country	Name	City	State
China	Ruijin Hospital, Shanghai jiaotong univestigy school of medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1-year progression-free survival	PFS is defined as the period from the start of receiving the first EC/EP chemotherapy plus PD-1/PD-L1 inhibitor to disease progression.	12 months after last patient entry
Secondary	1-year overall survival		12 months after last patient entry
Secondary	toxicities	Number of participants with treatment-related adverse events and the grade of adverse events as assessed by CTCAE v4.0	12 months after last patient entry
Secondary	5-year overall survival		5-year after last patient entry