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A Non-interventional Study With Resectable Stage II-IIIB Driver Gene-negative Non-small Cell Lung Cancer

Sponsor
Hunan Province Tumor Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05991206
Collaborator
(none)
200
Enrollment
1
Location
35
Anticipated Duration (Months)
5.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a descriptive observational study, in which data are collected in an epidemiological fashion and prospective. This study does not intend to intervene the current medical practice of the recruited patients.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Non-interventional Study and Its Clinical Relevance With Resectable Stage II-IIIB Driver Gene-negative Non-small Cell Lung Cancer
    Anticipated Study Start Date :
    Sep 1, 2023
    Anticipated Primary Completion Date :
    Dec 1, 2025
    Anticipated Study Completion Date :
    Aug 1, 2026

    Outcome Measures

    Primary Outcome Measures

    1. MPR Rate [2 years]

      Neoadjuvant therapy-induced tumor regression in pathologically residual tumors <10%

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • Patients must be ≥18 years.

    • Provision of fully informed consent prior to any study specific procedures.

    • Previously untreated, histologically confirmed resectable stage II, IIIA, IIIB (N2) (AJCC stage VIII) NSCLC; cTNM stage can be confirmed by PET-CT or pathological biopsy; resectable stage II non-small cell lung cancer is defined as radical resection as assessed by a qualified thoracic surgeon; resectable is resectable and potentially resectable as defined by the Expert Consensus on Multidisciplinary Diagnosis and Treatment of Stage III Non-small Cell Lung Cancer (2019 version); resectable includes IIIA (N0-1), some single-station mediastinal lymph node metastases with N2 and some T4 (satellite nodules present in adjacent lobes) N1; potentially resectable includes some stage IIIA and IIIB, including single-station N2 mediastinal lymph node short diameter < 3 cm stage IIIA NSCLC, potentially resectable T3 or T4 central tumors; Solid/solid pulmonary nodules, not pure ground-glass opacity (GGO), are strongly recommended for pathological puncture verification.

    • According to the RECIST 1.1 standard, the patient must have at least one measurable lesion.

    Exclusion Criteria:
    • None
    Exclusion Criteria:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hunan Cancer Hospital Changsha Hunan China 410013

    Sponsors and Collaborators

    • Hunan Province Tumor Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yongchang Zhang, Professor, Deputy Director of Thoracic Oncology Department, Hunan Province Tumor Hospital
    ClinicalTrials.gov Identifier:
    NCT05991206
    Other Study ID Numbers:
    • NATAL RWS
    First Posted:
    Aug 14, 2023
    Last Update Posted:
    Aug 14, 2023
    Last Verified:
    Aug 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma, Non-Small-Cell Lung

    Study Results

    No Results Posted as of Aug 14, 2023