Evaluating neoadjuvant immunotherapy for lung cancer treatment outcomes
Safety, Efficacy, and Survival Outcomes of Neoadjuvant/Induction Immunotherapy in Surgical and Radiotherapeutic Management of Non-Small Cell Lung Cancer: A Multicenter Real-World Study
This study is trying to see if giving immunotherapy before surgery helps people with non-small cell lung cancer live longer and feel better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking University Cancer Hospital & Institute Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 4 sites (Beijing, Beijing Municipality and 3 other locations) |
| Trial ID | NCT06926179 on ClinicalTrials.gov |
What this trial studies
This multicenter retrospective real-world study aims to assess the safety, efficacy, and survival outcomes of neoadjuvant immunotherapy in patients with non-small cell lung cancer (NSCLC). It encompasses various treatment pathways, including surgery and radiotherapy, to provide comprehensive real-world evidence that addresses existing gaps in clinical trials. By establishing a cohort that spans from the neoadjuvant therapy period to follow-up, the study seeks to inform treatment decisions for both operable and inoperable cases of lung cancer.
Who should consider this trial
Good fit: Ideal candidates include patients with histologically confirmed NSCLC who are clinically staged IA-IIIC and assessed as resectable or potentially resectable prior to treatment.
Not a fit: Patients with confirmed M1 disease or significant missing clinical data may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance treatment strategies and improve survival rates for patients with non-small cell lung cancer.
How similar studies have performed: Previous studies have shown success with neoadjuvant immunotherapy in NSCLC, but this study aims to provide novel real-world data to enhance understanding of its perioperative safety and efficacy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Histologically confirmed non-small cell lung cancer (NSCLC), regardless of the presence of EGFR or ALK sensitive driver gene mutations; 2. Clinical staging of IA-IIIC according to the AJCC 8th Edition before neoadjuvant treatment; 3. Received at least one cycle of neoadjuvant immunotherapy (with or without chemotherapy); 4. Assessed as resectable or potentially resectable by surgical experts prior to treatment. Exclusion Criteria: 1. Confirmed M1 disease; 2. History of previous lung malignancy or other metastatic malignant tumors; 3. Participation in other randomized controlled trials involving neoadjuvant treatment; 4. Significant missing clinical data.
Where this trial is running
Beijing, Beijing Municipality and 3 other locations
- Peking University Cancer Hospital & Institute — Beijing, Beijing Municipality, China (Recruiting)
- Peking University Third Hospital — Beijing, Beijing Municipality, China (Recruiting)
- Inner Mongolia Hospital of Peking University Cancer Hospital — Hohhot, Inner Mongolia, China (Recruiting)
- The Third Affliated Hospital of Kunming Medical University — Kunming, Yunnan, China (Recruiting)
Study contacts
- Study coordinator: Nan Wu, MD
- Email: nanwu@bjmu.edu.cn
- Phone: 0086-10-88196569
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.