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

Last Updated: 2023-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-25

Study Completion Date

2026-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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NSCLC

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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


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Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hunan Province Tumor Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yongchang Zhang

Professor, Deputy Director of Thoracic Oncology Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hunan Cancer Hospital

Changsha, Hunan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yongchang Zhang, MD

Role: CONTACT

Phone: +8613873123436

Email: [email protected]

Nong Yang

Role: CONTACT

Phone: +8613873123436

Email: [email protected]

Facility Contacts

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Nong Yang, MD

Role: primary

Yongchang Zhang, MD

Role: backup

Other Identifiers

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NATAL RWS

Identifier Type: -

Identifier Source: org_study_id