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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05085054
Recruitment Status : Not yet recruiting
First Posted : October 20, 2021
Last Update Posted : October 20, 2021
Information provided by (Responsible Party):
Wuhan Union Hospital, China

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.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Drug: Osimertinib Mesylate Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : November 1, 2021
Estimated Primary Completion Date : May 1, 2022
Estimated Study Completion Date : August 1, 2024

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. PFS [ Time Frame: 3 year ]
    Progression-Free Survival

Secondary Outcome Measures :
  1. OS [ Time Frame: 3 year ]
    Overall Survival

  2. Resectability rate [ Time Frame: 1 year ]
    Resectability rate is defined as the percentage of patients who were able to undergo surgery after neoadjuvant therapy.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT05085054

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Contact: Yongde Liao, PhD 15972212919
Contact: Guanchao Ye, PhD 13673503597

Sponsors and Collaborators
Wuhan Union Hospital, China
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Responsible Party: Wuhan Union Hospital, China Identifier: NCT05085054    
Other Study ID Numbers: SDANT
First Posted: October 20, 2021    Key Record Dates
Last Update Posted: October 20, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wuhan Union Hospital, China:
Advanced NSCLC
Targeted Therapy
Salvage Surgery
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action