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

Not yet recruiting

• Conditions: Non-small Cell Lung Cancer Stage ⅢA; Non-small Cell Lung Cancer Stage IIIB
• Interventions: Other: cycles of neoadjuvant therapy and duration of waiting for surgery

• Registration Number: NCT06394427
• Lead Sponsor: West China Hospital

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-28
• Study First Submitted QC: 2024-04-28
• Last Update Submitted: 2024-04-28
• Study Start: 2024-05
• Study First Posted: 2024-05-01
• Last Update Posted: 2024-05-01
• Primary Completion: 2024-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
chemoimmunotherapy group 2	cycles of neoadjuvant therapy and duration of waiting for surgery	the duration of before patients received surgery after neoadjuvant chemoimmunotherapy
chemoimmunotherapy group 1	cycles of neoadjuvant therapy and duration of waiting for surgery	patients received different cycles of neoadjuvant chemoimmunotherapy

Primary Outcome Measures

Name	Time	Method
major pathological remission	one month	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
survival time	5 years	time since diagnosed with NSCLC
pathological complete remission	one month	proportion of patients without residual viable tumor cell on evaluation of resected lung cancer specimens including all sampled regional lymph nodes