SRS for NSCLC With Oligo-residual Intracranial Disease After First-line 3rd Generation EGFR-TKI

Non-small Cell Lung Cancer Clinical Trial

Official title:

Stereotactic Radiotherapy for Non-small Cell Lung Cancer With Oligo-residual Intracranial Disease After First-line Third-generation EGFR Inhibitors: a Multicenter, Randomized Clinical Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06020066
• Other study ID #: 2306276-14
• Status: Recruiting
• Phase: Phase 2
• Start date: August 10, 2023
• Est. completion date: August 10, 2029

Study information

• Verified date: August 2023
• Source: Fudan University
• Contact: Zhengfei Zhu
• Phone: +8618017312901
• Email: fuscczzf[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Despite the impressive response rate to third-generation EGFR-TKIs, resistance inevitably develops in most patients. Stereotactic radiotherapy plays a growing role in the management of patients with brain metastasis. This study aims to evaluate the efficacy and safety of stereotactic radiotherapy for oligo-residual intracranial disease after first-line third-generation EGFR Inhibitors.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 202
• Est. completion date: August 10, 2029
• Est. primary completion date: August 10, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Pathologically confirmed non-small cell lung cancer;
• Clinical stage IV (AJCC, 8th edition, 2017);
• EGFR mutations: EGFR L858R, EGFR exon 19 deletion;
• Age =18 years;
• KPS score =70;
• Brain metastasis at the time of diagnosis;
• Complete baseline imaging assessment of metastatic lesions, including enhanced MRI for brain;
• Receiving first-line treatment with third-generation EGFR inhibitors;
• After 3-6 months of third-generation EGFR inhibitor treatment, imaging review indicates no progression of extracranial lesions, and brain lesions are evaluated by

thin-layer (1mm layer) enhanced MRI, meeting the following criteria:

• No more than 10 remaining brain lesions;
• The maximum diameter of the remaining brain lesions does not exceed 3cm;
• At least one remaining brain lesion has a diameter greater than 5mm;
• After evaluation by the researcher, all remaining brain lesions are suitable for stereotactic radiotherapy.
• Patient informed consent.

Exclusion Criteria:

• Poor compliance with the study protocol in the investigator's opinion;
• Patients withdrew their informed consent and requested to withdraw from the study;
• Patients were unable to receive regular doses of third-generation EGFR inhibitors due to other underlying conditions, viral side effects, economic factors, etc. (e.g., continuous discontinuation for more than 1 week, cumulative discontinuation for more than 2 weeks).
• Patients did not follow the protocol for follow-up visits as required by this study.

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• EGFR-TK Inhibitor
Patients will receive EGFR-TKI until confirmed progression or unacceptable toxicity.

Radiation:
• Stereotactic radiotherapy
Patients with oligo-residual intracranial disease after treatment with EGFR-TKI will be treated with SRS of all intracranial lesions. The choice of dose-fractionation regimen is at the discretion of the treating radiation oncologist.

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	PFS was measured from the date of the initiation of EGFR-TKI to the date of disease progression as defined by Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 or death	Two years
Secondary	Overall Survival	OS was defined as the time from the date of the initiation of EGFR-TKI until death by any cause. Participants still alive at the time of data analysis were censored at the date of last follow-up.	Three years
Secondary	Intracranial progression-free survival	iPFS was defined as the time from the start of third-generation EGFR-TKI treatment to the occurrence of intracranial disease progression or death. If the subject first experiences extracranial disease progression (without concurrent intracranial disease progression), the date of first extracranial disease progression will be used as the cut-off date. For patients who have not progressed at the time of analysis, the date of their last contact will be used as the cut-off date.	Two years
Secondary	Health-related quality of life per QLQ-C30	Health-related quality of life was evaluated using the QLQ-C30 questionnaires to assess health-related quality of life.	Two years
Secondary	Health-related quality of life per QLQ-LC13	Health-related quality of life was evaluated using the QLQ-LC13 questionnaires to assess health-related quality of life.	Two years
Secondary	Percentage of Participants With Adverse Events	Treatment-related adverse events were assessed and graded according to CTCAE v. 5.0.	Two years