First-line Treatment for ES-SCLC with Chemotherapy Combined with PD-1/PD-L1 Inhibitor Sequential Thoracic Radiotherapy

NCT06586697 | Recruiting Phase 2 DMC

• 1 other identifier: ES-SCLC-II-01
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Extensive-stage Small-cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• progression-free survival rate at 6-month

  PFS is defined as the period from the start of receiving the first line chemotherapy plus PD-1/PD-L1 inhibitor to disease progression.

  12 months after last patient entry

Study Arms (1)

Thoracic Radiotherapy

EXPERIMENTAL

Thoracic Radiotherapy (45Gy /1.5Gy/bid/3w)

Radiation: Thoracic Radiotherapy

Interventions

Thoracic Radiotherapy RADIATION

Thoracic Radiotherapy (45Gy /1.5Gy/bid/3w)

Thoracic Radiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

HenanCH

Zhengzhou, Henan, 450000, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Yang Liu

CONTACT

13676961186; zlyyliuyang1440@zzu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: September 19, 2024
• Study Start: December 1, 2023
• Primary Completion: January 1, 2026
• Study Completion: March 20, 2026
• Last Updated: September 19, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)