SBRT Combined With Osimertinib Compared With Osimertinib for Stage IV NSCLC

Li Zhang

Status: Not yet enrolling

Conditions: Stage IV Non-small Cell Lung Cancer

Treatments: Drug: Osimertinib 80 MG; Radiation: SBRT+Osimertinib

Study type: Interventional

Funder types: Other

Identifiers

NCT05583409

TJCC-LC002

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 Osimertinib

Enrollment: 72 estimated 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Osimertinib plus SBRT

Experimental group

Description:

SBRT with photon and dose is 40Gy/5F after three months after Osimertinib treatment

Treatment:

Radiation: SBRT+Osimertinib

Osimertinib

Active Comparator group

Description:

Osimertinib 80mg, po, Qd

Treatment:

Drug: Osimertinib 80 MG