A Study Describing Real-World Effectiveness of Nivolumab + Chemotherapy in Neoadjuvant NSCLC

NCT ID: NCT07141563

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-26
• Study Completion Date: 2025-11-18

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 (NSCLC)

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 with resectable non-small cell lung cancer (NSCLC). The primary objective is to estimate the rate of pathological complete response (pCR) following neoadjuvant therapy.

Adult patients (≥18 years) with newly diagnosed, early-stage, resectable NSCLC (stage IIA-IIIB, AJCC 8th ed) and no EGFR or ALK driver mutations who initiated neoadjuvant nivolumab (360 mg Q3W) plus platinum-based chemotherapy between July 1, 2022, and March 1, 2025, at participating Argentinian centers will be included. Data will be extracted retrospectively from medical records for up to 12 months following surgery or neoadjuvant therapy.

The primary endpoint is the pathological complete response (pCR), defined as absence of residual viable tumor in both lung and lymph nodes at surgery. Secondary endpoints include major pathological response (MPR), event-free survival (EFS) over 1 year, surgical outcomes, safety, and subsequent adjuvant therapy use. Descriptive and survival analyses will be performed.

Conditions

Non-small Cell Lung Cancer (NSCLC)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Cohort 1

Participants with resectable non-small cell lung cancer (NSCLC) receiving neoadjuvant treatment with nivolumab in combination with platinum-based chemotherapy

Nivolumab + platinum-based chemotherapy

Intervention Type: DRUG

According to the product label

Interventions

Nivolumab + platinum-based chemotherapy

According to the product label

Intervention Type: DRUG

Other Intervention Names

Opdivo, Cisplatin, Carboplatin, Pemetrexed, Paclitaxel, Gemcitabine.

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Grupo Argentino Oncología Torácica (GAOT) - Asociación Argentina Oncología Clínica (AAOC)

UNKNOWN

Sponsor Role: collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aldo Perfetti, MD

Role: PRINCIPAL_INVESTIGATOR

Asociación Argentina Oncología Torácica (AAOC)

Bristol Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Grupo Argentino Oncología Torácica (GAOT) - Asociación Argentina Oncología Clínica (AAOC)

Buenos Aires, , Argentina

Countries

Argentina

Related Links

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

FDA Safety Alerts and Recalls

Other Identifiers

CA209-1524

Identifier Type: -

Identifier Source: org_study_id