Status:
COMPLETED
A Study Describing Real-World Effectiveness of Nivolumab + Chemotherapy in Neoadjuvant NSCLC
Lead Sponsor:
Bristol-Myers Squibb
Collaborating Sponsors:
Grupo Argentino Oncología Torácica (GAOT) - Asociación Argentina Oncología Clínica (AAOC)
Conditions:
Non-small Cell Lung Cancer (NSCLC)
Eligibility:
All Genders
18+ years
Brief Summary
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 ...
Detailed Description
This is a non-interventional, retrospective, single-arm, multicenter study evaluating the real-world effectiveness of neoadjuvant nivolumab plus platinum-based chemotherapy in Argentinian patients wit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 26 2025
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 18 2025
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT07141563
Start Date
May 26 2025
End Date
November 18 2025
Last Update
January 7 2026
Active Locations (1)
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1
Grupo Argentino Oncología Torácica (GAOT) - Asociación Argentina Oncología Clínica (AAOC)
Buenos Aires, Argentina, C1426CPU