SBRT Combined With Osimertinib Compared With Osimertinib for Stage IV NSCLC

Not Applicable

Not yet recruiting

• Conditions: Stage IV Non-small Cell Lung Cancer
• Interventions: Radiation: SBRT+Osimertinib; Drug: Osimertinib 80 MG

• Registration Number: NCT05583409
• Lead Sponsor: Li Zhang

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-12
• Study First Submitted QC: 2022-10-13
• Last Update Submitted: 2022-10-13
• Study First Posted: 2022-10-17
• Last Update Posted: 2022-10-17
• Study Start: 2023-01-01
• Primary Completion: 2024-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 72

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.

7. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Osimertinib plus SBRT	SBRT+Osimertinib	SBRT with photon and dose is 40Gy/5F after three months after Osimertinib treatment
Osimertinib	Osimertinib 80 MG	Osimertinib 80mg, po, Qd

Primary Outcome Measures

Name	Time	Method
PFS	2 years	the time from the beginning of Osimertinib treatment to disease progression or death

Secondary Outcome Measures

Name	Time	Method
OS	3 years	the time from the beginning of Osimertinib treatment to death

Trial Locations

Locations (1)

Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, 430030, Hubei, P. R. China; 🇨🇳 Wuhan, Hubei, China