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

Completed

• Conditions: Chemotherapy; Tumour, Residual; Non Small Cell Lung Cancer; Immunotherapy
• Interventions: Drug: Timing of drug administration

• Registration Number: NCT05637580
• Lead Sponsor: Guangdong Provincial People's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-20
• Primary Completion: 2022-07-01
• Study Completion: 2022-07-01
• Status Verified: 2022-11
• Study First Submitted: 2022-11-24
• Study First Submitted QC: 2022-11-24
• Last Update Submitted: 2022-11-24
• Study First Posted: 2022-12-05
• Last Update Posted: 2022-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
combined well responder	Timing of drug administration	Both primary tumor and nodal response achieve major pathological response (MPR).
poor responder	Timing of drug administration	Primary tumor or/and nodal response can not achieve MPR.

Primary Outcome Measures

Name	Time	Method
Event-free survival	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.

Trial Locations

Locations (1)

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangdong, China