Maintenance Targeted Therapy With or Without Stereotactic Body Radiation Therapy for Stage IV Non-small Cell Lung Cancer

Phase 2

Completed

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

• Registration Number: NCT03595644
• Lead Sponsor: Tongji Hospital

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 a targeted agent such as gefitinib, erlotinib and icotinib.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-12
• Study First Submitted: 2018-06-19
• Study First Submitted QC: 2018-07-11
• Study First Posted: 2018-07-23
• Primary Completion: 2019-06-10
• Study Completion: 2020-12-10
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-05
• Last Update Posted: 2021-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

1. Patients must have biopsy proven metastatic NSCLC (Stage IV).
2. Patients must have received first line chemotherapy, from 4-6 cycles, and achieved stable disease or a partial response.
3. Patients receiving first-line erlotinib, gefitinib, or icotinib for EGFR mutant-positive for 3 months and achieved stable disease, partial response or completely response.
4. Age 18 to 75 years old.
5. Patients must have measurable disease at baseline.
6. The amount of metastatic focus <5.
7. ECOG score 0-2
8. Adequate normal organ and marrow function for TKI treatment and radiotherapy.
9. Patients must has sensitizing EGFR mutation (e.g. exon 19 deletion or exon 21 L858R)
10. 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
SBRT plus TKI group	SBRT+TKI	SBRT with photon and dose is 40-50Gy/5F after three months after EGFR-TKI treatment
TKI treatment group	TKI	Standard EGFR-TKI(Gefitinib, erlotinib or icotinib) Gefitinib: 250mg po Qd Erlotinib: 150mg po Qd Icotinib: 125mg po tid

Primary Outcome Measures

Name	Time	Method
PFS	2 years	Progression-free survival: From the first treatment to the date of first documentation of disease progression, or death due to any cause

Secondary Outcome Measures

Name	Time	Method
OS	3 year	Overall survival: From the first administration to death from any cause

Trial Locations

Locations (1)

Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China