SBRT Combined With Osimertinib Compared With Osimertinib for Stage IV NSCLC

NCT ID: NCT05583409

Last Updated: 2022-10-17

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2025-12-30

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 Osimertinib

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

SBRT plus Osimertinib versus Osimertinib
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Osimertinib plus SBRT

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

Group Type EXPERIMENTAL

SBRT+Osimertinib

Intervention Type RADIATION

Received SBRT after three months of Osimertinib treatment

Osimertinib

Osimertinib 80mg, po, Qd

Group Type ACTIVE_COMPARATOR

Osimertinib 80 MG

Intervention Type DRUG

Osimertinib 80mg, po, Qd

Interventions

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SBRT+Osimertinib

Received SBRT after three months of Osimertinib treatment

Intervention Type RADIATION

Osimertinib 80 MG

Osimertinib 80mg, po, Qd

Intervention Type DRUG

Eligibility Criteria

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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.

8\. 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hubei Cancer Hospital

OTHER

Sponsor Role collaborator

Li Zhang

OTHER

Sponsor Role lead

Responsible Party

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Li Zhang

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Li Zhang, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital, Affiliated to Tongji Medical College of Huazhong University of Science and Technology

Locations

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Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, 430030, Hubei, P. R. China

Wuhan, Hubei, China

Site Status

Countries

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China

Central Contacts

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Li Zhang, MD,PhD

Role: CONTACT

02783663407

Ping Peng, PhD

Role: CONTACT

02783663407

Other Identifiers

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TJCC-LC002

Identifier Type: -

Identifier Source: org_study_id

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