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

Maintenance Targeted Therapy With or Without Stereotactic Body Radiation Therapy for Stage IV Non-small Cell Lung Cancer: a Prospective, Multicenter, Randomized Controlled Clinical Trial.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03595644

Enrollment

Registered

2018-07-23

Start date

2017-02-12

Completion date

2020-12-10

Last updated

2021-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stage IV Non-small Cell Lung Cancer

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.

Interventions

RADIATIONSBRT+TKI

Received SBRT after three months after EGFR-TKI treatment

DRUGTKI

Received EGFR-TKI treatment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
OS	3 year	Overall survival: From the first administration to death from any cause

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026