A Real-World Study of Atezolizumab in Combination With Platinum-Based Doublet Chemotherapy as Neoadjuvant Therapy for Resectable Stage II-IIIB NSCLC
1 other identifier
observational
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2023
CompletedFirst Posted
Study publicly available on registry
August 14, 2023
CompletedStudy Start
First participant enrolled
December 25, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
ExpectedDecember 27, 2023
December 1, 2023
1.9 years
August 6, 2023
December 25, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
MPR Rate
Neoadjuvant therapy-induced tumor regression in pathologically residual tumors \<10%
2 years
Eligibility Criteria
stage II, IIIA, IIIB (N2) (AJCC stage VIII) NSCLC
You may qualify if:
- 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.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Deputy Director of Thoracic Oncology Department
Study Record Dates
First Submitted
August 6, 2023
First Posted
August 14, 2023
Study Start
December 25, 2023
Primary Completion
December 1, 2025
Study Completion (Estimated)
August 1, 2026
Last Updated
December 27, 2023
Record last verified: 2023-12