Status:
COMPLETED
SRT for Residual Oligometastases of NSCLC After 3rd Generation EGFR-TKIs
Lead Sponsor:
Fudan University
Conditions:
NSCLC Stage IV
EGFR Activating Mutation
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This study is an open-label, single-arm phase 2 trial to evaluate the efficacy and safety of stereotactic radiotherapy (SRT) for patients with oligo-residual NSCLC after 3rd generation EGFR-TKIs.
Eligibility Criteria
Inclusion
- The patient has a diagnosis of pathologically confirmed NSCLC by tumor biopsy and/or fine-needle aspiration.
- The patient has a diagnosis of American Joint Committee on Cancer (AJCC) 8th Edition stage IV NSCLC.
- The patient receives 3rd generation EGFR-TKI in the first line setting.
- The patient is ≥18 years of age and ≤75 years of age at the time of screening.
- The patient's Karnofsky performance score (KPS) is ≥70 at study entry.
- The patient has adequate baseline tumor assessment before initiation of 3rd generation EGFR-TKI.
- The patient has at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
- The patient presents with a residual "oligometastatic" state after 3rd generation EGFR-TKI therapy that would be amenable to consolidative SRT in the opinion of the investigator.
- The patient has signed informed consent.
- EGFR Exon19 deletion or Exon21 L858R mutation
Exclusion
- History of another malignancy or concurrent malignancy. Patients with cervical carcinoma in situ or adequately treated basal cell carcinoma who have been disease free for \> 5 years are eligible.
- The patient is pregnant (confirmed by serum b-HCG if applicable) or is breastfeeding.
- Patients with uncontrolled epilepsy, mental disorders, drug abuse, or social condition that may affect compliance or ability to sign a written informed consent in the opinion of the investigator.
- Patients with residual metastatic disease after 3rd generation EGFR-TKI therapy that is deemed not amenable to consolidative SRT.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 20 2023
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT04764214
Start Date
March 1 2021
End Date
July 20 2023
Last Update
August 19 2024
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, China