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

Non-small Cell Lung Cancer Stage IIIB Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06394427
• Other study ID #: 2024-674
• Status: Not yet recruiting
• Start date: May 2024
• Est. completion date: August 2025

Study information

• Verified date: April 2024
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: August 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

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

• ECOG score of 0 or 1; ? 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; ? Accepting preoperative neoadjuvant immunotherapy combined with chemotherapy; ? Receive surgical treatment after completion of neoadjuvant therapy; ? 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; ? Patients with severe liver/kidney dysfunction, cardiovascular disease, or systemic immune disorders;

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer Stage ?A
• Non-small Cell Lung Cancer Stage IIIB

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	survival time	time since diagnosed with NSCLC	5 years