Comparing outcomes of neoadjuvant immunochemotherapy and chemotherapy in lung cancer
Neoadjuvant Treatment Real-world Clinical Outcomes in NSCLC: A Retrospective Multi-center Study (NeoR-World)
This study is trying to see if a new type of treatment called immunochemotherapy works better than traditional chemotherapy for people with operable non-small cell lung cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05974007 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather real-world data on the clinical outcomes of neoadjuvant immunochemotherapy compared to traditional neoadjuvant chemotherapy in patients with operable non-small cell lung cancer (NSCLC). By analyzing a multi-center retrospective cohort, the study will evaluate pathologic response rates and overall survival, while also exploring the impact of various clinicopathological factors on these outcomes. The goal is to identify potential beneficiaries of neoadjuvant immunochemotherapy and optimize treatment strategies based on real-world evidence.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 85 with a confirmed diagnosis of stage I-III non-small cell lung cancer who have undergone neoadjuvant immunotherapy or chemotherapy followed by radical surgery.
Not a fit: Patients with prior surgeries, radiotherapy, or systemic therapy for NSCLC, as well as those participating in other clinical trials, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of neoadjuvant immunochemotherapy, potentially improving treatment options for patients with NSCLC.
How similar studies have performed: While there is limited real-world data on this specific approach, similar studies have shown promise in evaluating the effectiveness of neoadjuvant therapies in lung cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Cytological or histological diagnosis of non-small cell lung cancer 2. Patients who have previously undergone neoadjuvant immune checkpoint inhibitors and/or chemotherapy and then undergone radical surgery; 3. Stage I-III non-small cell lung cancer (IASLC/UICC staging eighth edition); 4. No previous history of malignant tumors and other malignant tumors at the same time, without any anti-tumor treatment; 5. ECOG score 0-1, heart, lung, liver, brain and kidney function can tolerate surgery; 6. At least one measurable lesion (RECIST v1.1); 7. Age \>= 18 years old and \<= 85 years old; 8. Be able to abide by the visits and related procedures stipulated in the program. Exclusion Criteria: 1. Patients included in anti-tumor drug intervention or unblinded clinical trials, in which the treatment being administered is unknown. 2. Prior surgery, radiotherapy or systemic therapy for NSCLC, including radiofrequency ablation, etc.
Where this trial is running
Beijing, Beijing Municipality
- National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Jie He, Dr.
- Email: prof.jiehe@gmail.com
- Phone: 010-87788863
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.