Salvage Surgery Following Downstaging of Advanced Non-small Cell Lung Cancer by Targeted Therapy (SDANT)

NCT ID: NCT05085054

Last Updated: 2022-05-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2024-08-01

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).

Conditions

Non Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

targeted therapy+salvage surgery

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.

Group Type: EXPERIMENTAL

Osimertinib Mesylate

Intervention Type: DRUG

Participants will receive targeted therapy followed by salvage surgery

Interventions

Osimertinib Mesylate

Participants will receive targeted therapy followed by salvage surgery

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Yongde Liao, PhD

Role: CONTACT

liaotjxw@126.com

15972212919

Guanchao Ye, PhD

Role: CONTACT

guanchaoye@qq.com

13673503597

Other Identifiers

SDANT

Identifier Type: -

Identifier Source: org_study_id