Clinical trial · Observational
A Study Describing Real-World Effectiveness of Nivolumab + Chemotherapy in Neoadjuvant NSCLC
Retrospective Study for Describing Real-World Effectiveness of Nivolumab + Chemotherapy in Neoadjuvant NSCLC in Argentina
NCT07141563CI-TRIAL-00100342completedClinicalTrials.gov clinicaltrialsProvenance
- 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 purpose of this study is to evaluate the real-world effectiveness and safety of neoadjuvant nivolumab combined with chemotherapy in Argentinian patients with resectable non-small cell lung cancer (NSCLC)
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 (NSCLC) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nivolumab + platinum-based chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Cohort 1
- description
- Participants with resectable non-small cell lung cancer (NSCLC) receiving neoadjuvant treatment with nivolumab in combination with platinum-based chemotherapy
- interventionNames
- Drug: Nivolumab + platinum-based chemotherapy
Primary outcomes (1)
- measure
- Rate of pathological complete response (pCR) post-surgery
- timeFrame
- Up to 1 year
- description
- Number of patients with complete pathological response (defined as absence of residual viable tumor in both lung and lymph nodes at surgery) divided by total number of patients.
Secondary outcomes (16)
- measure
- Event-free survival (EFS)
- timeFrame
- Up to 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants aged 18 years or older * Participants diagnosed with resectable non-small cell lung cancer (NSCLC) (stage IIA-IIIB TNM AJCC 8ed) according to the treating team's judgment * Participants who received nivolumab and chemotherapy as neoadjuvant therapy between 1st July 2022 and 1st March 2025 * Participants must have given informed consent for their data to be used for research or academic studies, or a waiver of consent has been obtained Exclusion Criteria: * Participants with confirmed positive EGFR gene mutation or ALK fusion gene, as the study focuses on the effectiveness of nivolumab in patients without these driver mutations * Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast * Participants who received any antineoplastic therapy within 3 months prior to initiating neoadjuvant nivolumab and chemotherapy, to avoid confounding effects from prior treatments * Participants who participated in a clinical trial for NSCLC, to ensure the study reflects real-world clinical practice * Participants with complications of treatment-related adverse events related to hematotoxicity of antineoplastic agents 3 months prior to the start of neoadjuvant therapy, to minimize risks and confounding factors * Participants who started neoadjuvant therapy outside the participating medical institution and were transferred to the institution for surgery, to ensure data consistency and reliability
References
Publications (0)
Data not yet available
No reference posted for this study.