SBRT Combined With Osimertinib Compared With Osimertinib for Stage IV NSCLC

Stage IV Non-small Cell Lung Cancer Clinical Trial

Official title:

Effect of SBRT Combined With Osimertinib Compared With Osimertinib Alone for Stage IV Non-small Cell Lung Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05583409
• Other study ID #: TJCC-LC002
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: October 2022
• Source: Tongji Hospital
• Contact: Li Zhang, MD,PhD
• Phone: 02783663407
• Email: luzigang[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Prospective, Multicenter, Randomized Controlled study to evaluate Stereotactic Body Radiation Therapy (SBRT) as a potential treatment for stage IV non-small cell lung cancer (NSCLC) that has a mutated epidermal growth factor receptor (EGFR) and has been receiving treatment with Osimertinib

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Patients must have biopsy proven metastatic NSCLC (Stage IV).

2. Patients receiving first-line Osimertinib for EGFR mutant-positive for 3 months and achieved stable disease or partial response.

3. Age 18 to 75 years old.

4. Patients must have measurable disease at baseline.

5. The amount of metastatic focus <5.

6. ECOG score 0-2 7 Adequate normal organ and marrow function for TKI treatment and radiotherapy.

8. Patients must has sensitizing EGFR mutation (e.g. exon 19 deletion or exon 21 L858R) 9. Patients must provide written informed consent to participate in the study.

Exclusion Criteria:

1. Patients who previously received radiotherapy to the primary site.

2. Patient can't tolerate radiotherapy or targeted therapy;

3. Pregnant or nursing women

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Stage IV Non-small Cell Lung Cancer

Intervention

Radiation:
• SBRT+Osimertinib
Received SBRT after three months of Osimertinib treatment

Drug:
• Osimertinib 80 MG
Osimertinib 80mg, po, Qd

Locations

Country	Name	City	State
China	Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, 430030, Hubei, P. R. China	Wuhan	Hubei

Sponsors (2)

Lead Sponsor	Collaborator
Li Zhang	Hubei Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	the time from the beginning of Osimertinib treatment to disease progression or death	2 years
Secondary	OS	the time from the beginning of Osimertinib treatment to death	3 years