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

Tongji Hospital

Status and phase: Completed; Phase 2

Conditions: Stage IV Non-small Cell Lung Cancer

Treatments: Drug: TKI; Radiation: SBRT+TKI

Study type: Interventional

Funder types: Other

Identifiers

NCT03595644

TJCC-LC001

Details and patient eligibility

About

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.

Enrollment: 74 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

SBRT plus TKI group

Experimental group

Description:

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

Treatment:

Radiation: SBRT+TKI

TKI treatment group

Active Comparator group

Description:

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

Treatment:

Drug: TKI