Evaluating outcomes of neoadjuvant immunotherapy in lung cancer patients
Real-world Clinical Outcomes of Neoadjuvant Immunotherapy in NSCLC Patients: A Retrospective, Multi-center, Cohort Study (NeoIM-Lung)
Cancer Institute and Hospital, Chinese Academy of Medical Sciences · NCT06317558
This study is testing how well different immune therapies work before surgery for people with non-small cell lung cancer to see who benefits the most.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 4000 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences (other) |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06317558 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effectiveness and long-term clinical outcomes of various neoadjuvant immunotherapies in patients with non-small cell lung cancer (NSCLC) using real-world data. It seeks to determine the optimal use of immune checkpoint inhibitors as neoadjuvant treatment and identify specific patient subgroups that benefit the most from this therapy. Participants will receive neoadjuvant immunotherapy, and the study will analyze their outcomes to refine treatment strategies for NSCLC management.
Who should consider this trial
Good fit: Ideal candidates include patients with a histological diagnosis of NSCLC (Stage I-IV) who have not received prior anti-tumor treatment.
Not a fit: Patients with a history of other malignant tumors or those who have undergone prior systemic therapy for NSCLC may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies and outcomes for patients with non-small cell lung cancer.
How similar studies have performed: Other studies have shown promise in using neoadjuvant immunotherapy for NSCLC, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Histological diagnosis of non-small cell lung cancer (Stage I-IV, International Association for the Study of Lung Cancer staging eighth edition) 2. Patients who have previously undergone immune checkpoint inhibitors as the neoadjuvant treatment; 3. No previous history of malignant tumors and other malignant tumors at the same time, without any anti-tumor treatment; 4. Eastern Cooperative Oncology Group (ECOG) score 0-1, heart, lung, liver, brain and kidney function can tolerate surgery; 5. At least one measurable lesion (RECIST v1.1). Exclusion Criteria: 1. Patients included in unblinded clinical trials or anti-tumor drug intervention. 2. Radiotherapy or systemic therapy were used for NSCLC patients before the surgery.
Where this trial is running
Beijing, Beijing Municipality
- Shugeng Gao — Beijing, Beijing Municipality, China (RECRUITING)
Study contacts
- Principal investigator: Shugeng Gao, MD — Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Study coordinator: Shugeng Gao, MD
- Email: gaoshugeng@cicams.ac.cn
- Phone: 8610-87788177
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.
Conditions: NSCLC