Clinical trial · Observational
Neoadjuvant Treatment Real-world Clinical Outcomes in NSCLC
Neoadjuvant Treatment Real-world Clinical Outcomes in NSCLC: A Retrospective Multi-center Study (NeoR-World)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Despite the clinical success of immune checkpoint blockade (ICB), in neoadjuvant setting, there is still a lack of valid data for operable NSCLC in the real world. This study aim to compare the clinical outcomes (pathologic response rate versus survival) of neoadjuvant immunochemotherapy with neoadjuvant chemotherapy in the real world, to explore the impact of clinicopathological factors on clinical outcomes in neoadjuvant immunochemotherapy setting, and to identify potential neoadjuvant immunochemotherapy beneficiaries.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neoadjuvant chemotherapy | Drug | — | UNRESOLVED |
| Neoadjuvant immunochemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Resectable stage I-III NSCLC
- description
- Patients with NSCLC patients receiving neoadjuvant therapy and undergoing surgeries. Resectability after neoadjuvant therapy is judged by the multidisciplinary team of thoracic surgeon, oncologist and radiation oncologist.
- interventionNames
- Drug: Neoadjuvant immunochemotherapy
- Drug: Neoadjuvant chemotherapy
Primary outcomes (2)
- measure
- Disease-free survival(DFS)
- timeFrame
- DFS was defined as the time from surgery to the appearance of metastasis, up to approximately 5 years.
- description
- Defined as the time from the date of randomization until the date of disease recurrence or death (by any cause in the absence of recurrence).
- measure
- Pathological Complete Response (pCR)
- timeFrame
- Within 2 weeks after surgery
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDYang Z, Wang S, Yang H, Jiang Y, Zhu L, Zheng B, Fu H, Ma J, Xie H, Wang Z, He H, Xia C, Li R, Xu J, Han J, Huang X, Li Y, Zhao B, Ni C, Xing H, Chen Y, Wang J, Jiang Y, Song Y, Mao Y, Chen C, Yao F, Zhang G, Hu J, Xue Q, Gao S, He J; NeoR-World Research Group. Treatment patterns and clinical outcomes of patients with resectable non-small cell lung cancer receiving neoadjuvant immunochemotherapy: A large-scale, multicenter, real-world study (NeoR-World). J Thorac Cardiovasc Surg. 2024 Oct;168(4):1245-1258.e17. doi: 10.1016/j.jtcvs.2024.02.006. Epub 2024 Feb 10. PMID 38342430