Pathological Tumor and Lymph Node Responses After Neoadjuvant Immunochemotherapy in Initially-unresectable NSCLC

This is a real-world study with the largest sample size investigating the pathological tumor and lymph node responses to neoadjuvant immunochemotherapy in non-small cell lung cancer to date. Patients with initially unresectable NSCLC underwent immunochemotherapy and response to treatment was assessed after every two treatment cycles. Clinicopathologic features of patients including epidemiological data, clinical manifestations, operation strategies, pathological findings, and prognostic information were recorded and evaluated.

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Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Chemotherapy Immunotherapy Lung Diseases Lung Neoplasms Neoplasm, Residual Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Tumour, Residual

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with stage III NSCLC who received neoadjuvant immunochemotherapy.
early-stage NSCLC patients who were initially unresectable.
18 years of age or older.
Karnofsky performance status (KPS) score of 100 or 90.

Exclusion criteria

Patients with stage IV NSCLC
Patients with known ALK translocations or EGFR mutations.
Karnofsky performance status (KPS) score <90.

Treatment and study plan

Timing of drug administration

Drug

The effect of drug administration timing on tumor and lymph node responses was observed.

Primary outcomes

Event-free survival

Time frame: At least one year

the time from diagnosis to any progression of disease precluding surgery, progression or recurrence of disease after surgery or death from any cause.

Sponsors and collaborators

Lead sponsor

Guangdong Provincial People's Hospital

Other

Registry information

Official study title

Real-world Analysis of Pathological Tumor and Lymph Node Responses After Neoadjuvant Immunochemotherapy in Initially-unresectable Non-small Cell Lung Cancer

Important dates

Study start: 2019
Primary completion: 2022
Study completion: 2022
First posted: Dec 5, 2022
Registry last updated: Dec 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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