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

NCT06394427 | Not Yet Recruiting

• 1 other identifier: 2024-674
• Study Type: observational
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Non-small Cell Lung Cancer Stage ⅢA; Non-small Cell Lung Cancer Stage IIIB

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

chemoimmunotherapy group 1

patients received different cycles of neoadjuvant chemoimmunotherapy

Other: cycles of neoadjuvant therapy and duration of waiting for surgery

chemoimmunotherapy group 2

the duration of before patients received surgery after neoadjuvant chemoimmunotherapy

Other: cycles of neoadjuvant therapy and duration of waiting for surgery

Interventions

cycles of neoadjuvant therapy and duration of waiting for surgery OTHER

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 1; chemoimmunotherapy group 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

locally advanced NSCLC meeting the above crateria

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Hospital: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: April 28, 2024
• First Posted: May 1, 2024
• Study Start: May 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2025
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share