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

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

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.

Study Overview

• Status: Completed
• Conditions: Chemotherapy; Non Small Cell Lung Cancer; Immunotherapy; Tumour, Residual
• Intervention / Treatment: Drug: Timing of drug administration

• Study Type: Observational
• Enrollment (Actual): 110

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Guangdong Provincial People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with stage II-III NSCLC who received neoadjuvant immunochemotherapy (time) in Guangdong Provincial People's Hospital were eligible for this study. We also included early-stage NSCLC patients who were unsuitable or unable to tolerate surgery after first evaluation. Eligible patients were 18 years of age or older, had a karnofsky performance status (KPS) score of 100 or 90 (on a scale from 0 to 100 with higher score indicating better ability to carry out daily activities). Patients with distant tumor metastasis or with known ALK translocations or EGFR mutations were excluded.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
combined well responder; Both primary tumor and nodal response achieve major pathological response (MPR).	Drug: Timing of drug administration; The effect of drug administration timing on tumor and lymph node responses was observed.
poor responder; Primary tumor or/and nodal response can not achieve MPR.	Drug: Timing of drug administration; The effect of drug administration timing on tumor and lymph node responses was observed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Guangdong Provincial People's Hospital
• Investigators: Study Director: Guibin Qiao, MD, Guangdong Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2019
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: November 24, 2022
• First Submitted That Met QC Criteria: November 24, 2022
• First Posted (Actual): December 5, 2022

Study Record Updates

• Last Update Posted (Actual): December 5, 2022
• Last Update Submitted That Met QC Criteria: November 24, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Neoplastic Processes; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Neoplasm, Residual
• Other Study ID Numbers: LUNGTN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No