Clinical trial · Observational
Survival Analysis and Prognostic Biomarker Exploration of Postoperative Adjuvant Therapy Patterns in Patients With Non-small Cell Lung Cancer After Neoadjuvant Immunotherapy
Survival Analysis and Prognostic Biomarker Exploration of Postoperative Adjuvant Therapy Patterns in Patients With Non-small Cell Lung Cancer After Neoadjuvant Immunotherapy:A Real World Multicenter Retrospective 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)
The aim of this observational study is to investigate the survival differences among patients with non-small cell lung cancer who received different adjuvant treatments after neoadjuvant immunotherapy, and to identify the main clinical characteristics of these survival differences. The main question it aims to answer is: 1. Is there a difference in survival between patients who achieve pCR after neoadjuvant immunotherapy and those who do not receive adjuvant therapy? 2. What are the recurrence patterns and high-risk factors for recurrence in patients with pCR after neoadjuvant immunotherapy, and how can early intervention be carried out? 3. Is there a difference in survival among patients with non-MPR after neoadjuvant immunotherapy when they receive different adjuvant treatment modalities (single immunotherapy, chemio-immunotherapy, chemotherapy, etc.)? 4. Should patients with non-MPR after neoadjuvant immunotherapy continue immunotherapy, and what are the predictive markers for receiving adjuvant therapy?
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 |
|---|---|---|---|
| Lung Cancer (NSCLC) | Malignant Lung Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| PD-1 Inhibitors | Drug | — | UNRESOLVED |
| PD-1 inhibitors combined with chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall Survival (OS)
- timeFrame
- From date of diagnosis until the date of death from any cause, whichever came first, assessed up to 7 years and 11 months.
- description
- OS is defined as the time from surgery time until death from any cause.
Secondary outcomes (2)
- measure
- Event-free survival(EFS)
- timeFrame
- up to 7 years and 11 months.
- description
- Event-free survival was defined as the time from neoadjuvant treatment to metastasis or death by any cause in the absence of metastasis.
- measure
- Pathological Complete Response(pCR)
- timeFrame
- up to 1 month after surgery
- description
- After evaluating the removed tumor tissue and the regional lymph nodes, no residual tumor cells were found.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients who visited the hospital from January 2020 to December 2023; 2. Received neoadjuvant immunotherapy before surgery; 3. Histologically diagnosed with stage II-III NSCLC; 4. Had measurable lesions as assessed by the investigator using the RECIST 1.1 version; 5. Underwent radical surgical treatment; 6. ECOG score of 0 or 1; 7. Available tumor tissue samples; 8. Good blood and organ functions. Exclusion Criteria: 1. Has received other anti-tumor treatments before, including radiotherapy, chemotherapy and traditional Chinese medicine-based cancer treatment (except for malignant tumor treatments that have been cured and have no recurrence or metastasis for more than 5 years); 2. Has a history of previous malignant tumors.
References
Publications (0)
Data not yet available