Back to resultsSalvage Surgery Following Downstaging of Advanced Non-small Cell Lung Cancer by Targeted Therapy (SDANT)
Primary Purpose
Non Small Cell Lung Cancer
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Osimertinib Mesylate
Sponsored by
About this trial
This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring Unresectable, Advanced NSCLC, Targeted Therapy, Salvage Surgery
Eligibility Criteria
Inclusion Criteria:
- Pathological diagnosis of NSCLC with confirmed activation of driver gene mutation (EGFR mutant: exon 19 deletion or exon 21 L858R mutation; ALK-rearrangement) by amplification refractory mutation system (ARMS);
- stage IIIB-IV according to the eighth edition of the American Joint Committee on Cancer staging system confirmed by pathological diagnosis and positron emission tomography-computed tomography (PET-CT) and biopsy
- Written informed consent provided；
- Age 18-70 when signing the consent form, both male and female;
- The ECOG score is 0 or 1;
- Adequate hematological function, liver function and renal function;
- Female participants should not be pregnant or breast-feeding.
Exclusion Criteria:
- Previously received systemic anti-tumor therapy for non-small cell lung cancer;
- Subjects who have received chest radiotherapy in the past;
- Known human immunodeficiency virus (HIV) infection;
- Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease);
- Pregnancy or breast-feeding women;
- Ingredients mixed with small cell lung cancer patients.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
targeted therapy+salvage surgery
Arm Description
Participants treated with targeted therapy without progression and radiological confirmation of tumor downstaging (≤stage IIIA) by PET-CT followed by salvage surgery were enrolled into the group of targeted therapy plus salvage surgery. The molecular targeted agents used in our study included osimertinib (80 mg, once a day) . Salvage surgery was defined as surgical intervention based on standard operation (lobectomy plus lymphadenectomy) of NSCLC for advanced patients who initially had no surgical indications, but achieved significant downstaging (≤stage IIIA) without progression after targeted therapy. Targeted therapy was continued after salvage surgery until progression.
Outcomes
Primary Outcome Measures
PFS
Progression-Free Survival
Secondary Outcome Measures
OS
Overall Survival
Resectability rate
Resectability rate is defined as the percentage of patients who were able to undergo surgery after neoadjuvant therapy.
Full Information
NCT ID
NCT05085054
First Posted
September 21, 2021
Last Updated
May 18, 2022
Sponsor
Wuhan Union Hospital, China
1. Study Identification
Unique Protocol Identification Number
NCT05085054
Brief Title
Salvage Surgery Following Downstaging of Advanced Non-small Cell Lung Cancer by Targeted Therapy (SDANT)
Official Title
Induction Therapy With Targeted Therapy Followed by Surgery for Stage IIIB and IV Non-small Cell Lung Cancer: a Multi-center, Single-arm, Prospective Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2022 (Anticipated)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wuhan Union Hospital, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of neoadjuvant targeted therapy followed by surgery in participants with advanced non-small cell lung cancer.
Detailed Description
Advanced non-small cell lung cancer (NSCLC) accounts for a high proportion of lung cancer cases. Targeted therapy improve the survival in these patients, but acquired drug resistance will inevitably occur. If tumor downstaging is achieved after targeted therapy, could surgical resection before drug resistance improve clinical benefits for patients with advanced NSCLC? Here, the investigators conducted a clinical trial showing that for patients with advanced driver gene mutant NSCLC who did not progress after targeted therapy, salvage surgery (SS) could improve progression-free survival (PFS).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
Keywords
Unresectable, Advanced NSCLC, Targeted Therapy, Salvage Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
targeted therapy+salvage surgery
Arm Type
Experimental
Arm Description
Participants treated with targeted therapy without progression and radiological confirmation of tumor downstaging (≤stage IIIA) by PET-CT followed by salvage surgery were enrolled into the group of targeted therapy plus salvage surgery.
The molecular targeted agents used in our study included osimertinib (80 mg, once a day) . Salvage surgery was defined as surgical intervention based on standard operation (lobectomy plus lymphadenectomy) of NSCLC for advanced patients who initially had no surgical indications, but achieved significant downstaging (≤stage IIIA) without progression after targeted therapy.
Targeted therapy was continued after salvage surgery until progression.
Intervention Type
Drug
Intervention Name(s)
Osimertinib Mesylate
Intervention Description
Participants will receive targeted therapy followed by salvage surgery
Primary Outcome Measure Information:
Title
PFS
Description
Progression-Free Survival
Time Frame
3 year
Secondary Outcome Measure Information:
Title
OS
Description
Overall Survival
Time Frame
3 year
Title
Resectability rate
Description
Resectability rate is defined as the percentage of patients who were able to undergo surgery after neoadjuvant therapy.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pathological diagnosis of NSCLC with confirmed activation of driver gene mutation (EGFR mutant: exon 19 deletion or exon 21 L858R mutation; ALK-rearrangement) by amplification refractory mutation system (ARMS);
stage IIIB-IV according to the eighth edition of the American Joint Committee on Cancer staging system confirmed by pathological diagnosis and positron emission tomography-computed tomography (PET-CT) and biopsy
Written informed consent provided；
Age 18-70 when signing the consent form, both male and female;
The ECOG score is 0 or 1;
Adequate hematological function, liver function and renal function;
Female participants should not be pregnant or breast-feeding.
Exclusion Criteria:
Previously received systemic anti-tumor therapy for non-small cell lung cancer;
Subjects who have received chest radiotherapy in the past;
Known human immunodeficiency virus (HIV) infection;
Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease);
Pregnancy or breast-feeding women;
Ingredients mixed with small cell lung cancer patients.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yongde Liao, PhD
Phone
15972212919
Email
liaotjxw@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Guanchao Ye, PhD
Phone
13673503597
Email
guanchaoye@qq.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Salvage Surgery Following Downstaging of Advanced Non-small Cell Lung Cancer by Targeted Therapy (SDANT)
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