Clinical trial · Observational
Safety, Efficacy, and Survival Outcomes of Neoadjuvant/Induction Immunotherapy in Surgical and Radiotherapeutic Management of Non-Small Cell Lung Cancer
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
- 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)
This multicenter retrospective real-world study aims to evaluate the safety, efficacy and survival outcomes of neoadjuvant/induction immunotherapy in patients with non-small cell lung cancer (NSCLC). The study covers diverse treatment pathways, including surgery, definitive radiotherapy, and non-surgical strategies. It addresses gaps in existing trials by establishing a comprehensive cohort spanning neoadjuvant/induction therapy, perioperative management, and follow-up, providing real-world evidence to support treatment decisions in both operable and inoperable cases.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer (NSCLC) | Malignant Lung Neoplasm | CURATED_EXACT | 0.85 |
| Lung Surgery | — | UNRESOLVED | — |
| Neoadjuvant Immunotherapy | — | UNRESOLVED | — |
| Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| neoadjuvant immunotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Technical Dissection Difficulty (TDD) Rate
- timeFrame
- During the radical surgery (Day 0 of surgery)
- description
- Defined as the intraoperative presence of fibrosis and/or tight adhesion between lymph nodes and surrounding structures around the hilar and fissure. TDD is considered present if either fibrosis or significant adhesion is noted, potentially increasing surgical complexity. Surgical difficulty is assessed based on operative reports and predefined intraoperative criteria, as documented by the operating surgeon.
- measure
- Disease-Free Survival (DFS)
- timeFrame
- From the date of radical surgery to the date of disease recurrence, progression, death, or last follow-up, up to 5 years.
- description
- Defined as the time from the date of radical surgery to the first occurrence of disease recurrence, progression, or death from any cause. Patients without an event will be censored at the date of the last follow-up. Disease status is determined through radiological, pathological, or clinical assessment as documented during follow-up.
Secondary outcomes (12)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDTao Y, Guo R, Li X, Cui X, Wang Y, Du H, Wen Z, Yan S, Li N, Wu N. Prognostic value of 18F-FDG PET/CT metabolic parameters in patients with non-small cell lung cancer who achieved a pathological complete response after neoadjuvant chemoimmunotherapy. Cancer Imaging. 2026 Jun 4. doi: 10.1186/s40644-026-01057-1. Online ahead of print. PMID 42237141