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NCT05991206 Clinical Trial

A Real-World Study of Atezolizumab in Combination With Platinum-Based Doublet Chemotherapy as Neoadjuvant Therapy for Resectable Stage II-IIIB NSCLC

NSCLC Clinical Trial

Official title:
A Real-World Study of Atezolizumab in Combination With Platinum-Based Doublet Chemotherapy as Neoadjuvant Therapy for Resectable Stage II-IIIB Driver Gene-Negative Non-Small Cell Lung Cancer (NSCLC)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05991206
Other study ID # NATAL RWS
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 25, 2023
Est. completion date August 1, 2026

Study information
Verified date December 2023
Source Hunan Province Tumor Hospital
Contact Yongchang Zhang, MD
Phone +8613873123436
Email zhangyongchang@csu.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date August 1, 2026
Est. primary completion date December 1, 2025
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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: -

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Hunan Cancer Hospital Changsha Hunan

Sponsors (1)
Lead Sponsor Collaborator
Hunan Province Tumor Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary MPR Rate Neoadjuvant therapy-induced tumor regression in pathologically residual tumors <10% 2 years
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