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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Non Small Cell Lung Cancer
• Intervention / Treatment: Drug: Osimertinib Mesylate

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).

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yongde Liao, PhD; Phone Number: 15972212919; Email: liaotjxw@126.com
• Study Contact Backup: Name: Guanchao Ye, PhD; Phone Number: 13673503597; Email: guanchaoye@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: 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.

Drug: Osimertinib Mesylate; Participants will receive targeted therapy followed by salvage surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	Progression-Free Survival	3 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	Overall Survival	3 year
Resectability rate	Resectability rate is defined as the percentage of patients who were able to undergo surgery after neoadjuvant therapy.	1 year

Collaborators and Investigators

• Sponsor: Wuhan Union Hospital, China

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2022
• Primary Completion (ANTICIPATED): May 1, 2024
• Study Completion (ANTICIPATED): August 1, 2024

Study Registration Dates

• First Submitted: September 21, 2021
• First Submitted That Met QC Criteria: October 7, 2021
• First Posted (ACTUAL): October 20, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 20, 2022
• Last Update Submitted That Met QC Criteria: May 18, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Unresectable; Targeted Therapy; Advanced NSCLC; Salvage Surgery
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Osimertinib
• Other Study ID Numbers: SDANT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No