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Trial Title:
A Real-World Study of Atezolizumab in Combination With Platinum-Based Doublet Chemotherapy as Neoadjuvant Therapy for Resectable Stage II-IIIB NSCLC
NCT ID:
NCT05991206
Condition:
NSCLC
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
stage II, IIIA, IIIB (N2) (AJCC stage VIII) NSCLC
Sampling method:
Probability Sample
Criteria:
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:
-
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Locations:
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410013
Country:
China
Status:
Recruiting
Contact:
Last name:
Nong Yang, MD
Phone:
+86 731 89762323
Email:
yangnong0217@163.com
Contact backup:
Last name:
Yongchang Zhang, MD
Phone:
+86 731 89762321
Email:
zhangyongchang@csu.edu.cn
Start date:
December 25, 2023
Completion date:
August 1, 2026
Lead sponsor:
Agency:
Hunan Province Tumor Hospital
Agency class:
Other
Source:
Hunan Province Tumor Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05991206
