SBRT Combined With Osimertinib Compared With Osimertinib for Stage IV NSCLC

Effect of SBRT Combined With Osimertinib Compared With Osimertinib Alone for Stage IV Non-small Cell Lung Cancer

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

Study Overview

• Status: Not yet recruiting
• Conditions: Stage IV Non-small Cell Lung Cancer
• Intervention / Treatment: Radiation: SBRT+Osimertinib; Drug: Osimertinib 80 MG

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Li Zhang, MD,PhD; Phone Number: 02783663407; Email: luzigang@163.com
• Study Contact Backup: Name: Ping Peng, PhD; Phone Number: 02783663407; Email: pengpingtj@163.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Osimertinib plus SBRT; SBRT with photon and dose is 40Gy/5F after three months after Osimertinib treatment	Radiation: SBRT+Osimertinib; Received SBRT after three months of Osimertinib treatment
Active Comparator: Osimertinib; Osimertinib 80mg, po, Qd	Drug: Osimertinib 80 MG; Osimertinib 80mg, po, Qd

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	the time from the beginning of Osimertinib treatment to disease progression or death	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	the time from the beginning of Osimertinib treatment to death	3 years

Collaborators and Investigators

• Sponsor: Li Zhang
• Collaborators: Hubei Cancer Hospital
• Investigators: Principal Investigator: Li Zhang, MD,PhD, Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): December 30, 2024
• Study Completion (Anticipated): December 30, 2025

Study Registration Dates

• First Submitted: October 12, 2022
• First Submitted That Met QC Criteria: October 13, 2022
• First Posted (Actual): October 17, 2022

Study Record Updates

• Last Update Posted (Actual): October 17, 2022
• Last Update Submitted That Met QC Criteria: October 13, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Osimertinib
• Other Study ID Numbers: TJCC-LC002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No