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

Non Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05637580
• Other study ID #: LUNGTN
• Status: Completed
• Start date: May 20, 2019
• Est. completion date: July 1, 2022

Study information

• Verified date: November 2022
• Source: Guangdong Provincial People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Chemotherapy
• Immunotherapy
• Lung Neoplasms
• Neoplasm, Residual
• Non Small Cell Lung Cancer

Intervention

Drug:
• Timing of drug administration
The effect of drug administration timing on tumor and lymph node responses was observed.

Locations

Country	Name	City	State
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event-free survival	the time from diagnosis to any progression of disease precluding surgery, progression or recurrence of disease after surgery or death from any cause.	At least one year