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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-12

Study Completion Date

2020-12-10

Brief Summary

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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.

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Detailed Description

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Conditions

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Stage IV Non-small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SBRT plus TKI group

SBRT with photon and dose is 40-50Gy/5F after three months after EGFR-TKI treatment

Group Type EXPERIMENTAL

SBRT+TKI

Intervention Type RADIATION

Received SBRT after three months after EGFR-TKI treatment

TKI treatment group

Standard EGFR-TKI(Gefitinib, erlotinib or icotinib) Gefitinib: 250mg po Qd Erlotinib: 150mg po Qd Icotinib: 125mg po tid

Group Type ACTIVE_COMPARATOR

TKI

Intervention Type DRUG

Received EGFR-TKI treatment

Interventions

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SBRT+TKI

Received SBRT after three months after EGFR-TKI treatment

Intervention Type RADIATION

TKI

Received EGFR-TKI treatment

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No