Neoadjuvant Chemoimmunotherapy in Stage IIIA- N2IIIB Non-small Cell Lung Cancer

Influence of Neoadjuvant Chemoimmunotherapy on Treatment Response in Stage IIIA- N2IIIB Non-small Cell Lung Cancer

to explore the impact of preoperative neoadjuvant immunotherapy on perioperative outcomes and long-term prognosis of locally advanced NSCLC in the real world

Study Overview

• Status: Not yet recruiting
• Conditions: Non-small Cell Lung Cancer Stage IIIB; Non-small Cell Lung Cancer Stage ⅢA
• Intervention / Treatment: Other: cycles of neoadjuvant therapy and duration of waiting for surgery

• Study Type: Observational
• Enrollment (Estimated): 250

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

locally advanced NSCLC meeting the above crateria

Description

Inclusion Criteria:

• Confirmed as primary lung cancer through cytology or histological examination;

  • ECOG score of 0 or 1; ③ 18 years old or above;

    • Received imaging examination, with a preliminary clinical staging of stage III;

      • Received genetic testing and tested negative for EGFR mutations, ALK or ROS-1 fusion; ⑥ Accepting preoperative neoadjuvant immunotherapy combined with chemotherapy; ⑦ Receive surgical treatment after completion of neoadjuvant therapy; ⑧ The postoperative specimens were sent to the pathology department of our hospital for pathological testing, and a complete pathological report is available.

Exclusion Criteria:

• Patients with combined small cell lung cancer; ② Patients with severe liver/kidney dysfunction, cardiovascular disease, or systemic immune disorders;

  • Accept other neoadjuvant treatments; ④ Patients participating in any clinical trial.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
chemoimmunotherapy group 1; patients received different cycles of neoadjuvant chemoimmunotherapy	Other: cycles of neoadjuvant therapy and duration of waiting for surgery; We intended to explore the cycles of neoadjuvant therapy and duration of waiting for surgery on the perioperative outcomes and long-term prognosis of locally advanced NSCLC in the real world
chemoimmunotherapy group 2; the duration of before patients received surgery after neoadjuvant chemoimmunotherapy	Other: cycles of neoadjuvant therapy and duration of waiting for surgery; We intended to explore the cycles of neoadjuvant therapy and duration of waiting for surgery on the perioperative outcomes and long-term prognosis of locally advanced NSCLC in the real world

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
major pathological remission	proportion of patients with no more than 10% residual viable tumor cells; patients who showed no viable tumor in the lung primary setting but lymph nodes show viable metastatic carcinoma were also classified as MPR	one month
pathological complete remission	proportion of patients without residual viable tumor cell on evaluation of resected lung cancer specimens including all sampled regional lymph nodes	one month
survival time	time since diagnosed with NSCLC	5 years

Collaborators and Investigators

• Sponsor: West China Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: April 28, 2024
• First Submitted That Met QC Criteria: April 28, 2024
• First Posted (Actual): May 1, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 28, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 2024-674

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The datasets are available upon reasonable request.

Drug and device information, study documents

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