Back to resultsSBRT for Residual Oligometastases of NSCLC After 3rd Generation EGFR-TKIs
Primary Purpose
NSCLC Stage IV, EGFR T790M
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
3rd generation EGFR-TKI
Consolidative SBRT
Sponsored by
About this trial
This is an interventional treatment trial for NSCLC Stage IV
Eligibility Criteria
Inclusion Criteria:
- 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 after progression on 1st or 2nd generation EGFR-TKI with either tissue or liquid biopsy-confirmed acquired T790M mutation.
- 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 SBRT in the opinion of the investigator.
- The patient has signed informed consent.
Exclusion Criteria:
- 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 confirmed to be negative for T790M mutation or patients in whom the T790M status is not evaluated after progression on 1st or 2nd generation EGFR-TKI.
- 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 SBRT.
Sites / Locations
- Fudan University Shanghai Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
3rd generation EGFR-TKI+ SBRT
Arm Description
Outcomes
Primary Outcome Measures
Progression Free Survival
PFS was measured from the date of enrollment to the date of disease progression as defined by Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 or death due to any cause, whichever occurred first. For patients whose disease did not progress, PFS was evaluated by censoring patients at their most recent imaging.
Secondary Outcome Measures
Percentage of Participants With Adverse Events
Treatment-related adverse events were assessed and graded according to CTCAE v. 5.0.
Overall Survival
OS was defined as the time from the date of enrollment until death by any cause. Participants still alive at the time of data analysis were censored at the date of last follow-up.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04764214
Brief Title
SBRT for Residual Oligometastases of NSCLC After 3rd Generation EGFR-TKIs
Official Title
An Open-label, Single-Arm, Phase 2 Trial of Stereotactic Body Radiotherapy for Patients With Residual Oligometastases of NSCLC After 3rd Generation EGFR-TKIs
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study is an open-label, single-arm phase 2 trial to evaluate the efficacy and safety of stereotactic body radiotherapy (SBRT) for patients with residual oligometastases of NSCLC after 3rd generation EGFR-TKIs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NSCLC Stage IV, EGFR T790M
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
3rd generation EGFR-TKI+ SBRT
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
3rd generation EGFR-TKI
Other Intervention Name(s)
Osimertinib
Intervention Description
Osimertinib will be administered orally at the dose of 80 mg once daily.
Intervention Type
Radiation
Intervention Name(s)
Consolidative SBRT
Intervention Description
Patients who possess oligoresidual disease after 3rd generation EGFR-TKI therapy will be treated with the intent to ablate all residual disease with consolidative SBRT. The choice of dose-fractionation regimen is at the discretion of the treating radiation oncologist. TKI will be continued during and after consolidative SBRT until disease progression or intolerable toxicity.
Primary Outcome Measure Information:
Title
Progression Free Survival
Description
PFS was measured from the date of enrollment to the date of disease progression as defined by Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 or death due to any cause, whichever occurred first. For patients whose disease did not progress, PFS was evaluated by censoring patients at their most recent imaging.
Time Frame
Two years
Secondary Outcome Measure Information:
Title
Percentage of Participants With Adverse Events
Description
Treatment-related adverse events were assessed and graded according to CTCAE v. 5.0.
Time Frame
Two years
Title
Overall Survival
Description
OS was defined as the time from the date of enrollment until death by any cause. Participants still alive at the time of data analysis were censored at the date of last follow-up.
Time Frame
Two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 or after progression on 1st or 2nd generation EGFR-TKI with either tissue or liquid biopsy-confirmed acquired T790M mutation.
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 SBRT in the opinion of the investigator.
The patient has signed informed consent.
Exclusion Criteria:
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 confirmed to be negative for T790M mutation or patients in whom the T790M status is not evaluated after progression on 1st or 2nd generation EGFR-TKI.
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 SBRT.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhengfei Zhu, MD
Phone
+86-18017312901
Email
fuscczzf@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jianjiao Ni, MD
Phone
13761974092
Email
nijianjiao8@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhengfei Zhu, MD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhengfei Zhu, MD
Phone
+86-18017312901
Email
fuscczzf@163.com
First Name & Middle Initial & Last Name & Degree
Jianjiao Ni, MD
Phone
13761974092
Email
nijianjiao8@sina.com
12. IPD Sharing Statement
Learn more about this trial
SBRT for Residual Oligometastases of NSCLC After 3rd Generation EGFR-TKIs
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