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

NCT07141563 | Completed FDA Drug

• 1 other identifier: CA209-1524
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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)

Conditions

Non-small Cell Lung Cancer (NSCLC)

Keywords

Non-small cell lung cancer (NSCLC)

Outcome Measures

Primary Outcomes (1)

• Rate of pathological complete response (pCR) post-surgery

  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.

  Up to 1 year

Secondary Outcomes (16)

• Event-free survival (EFS)

  Up to 1 year

• Rate of major pathological response (MPR) post-surgery

  Up to 1 year

• Participant demographics

  Baseline

• Participant clinical characteristics

  Baseline

• Number of participants receiving surgery

  Up to 1 year

Study Arms (1)

Cohort 1

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

Drug: Nivolumab + platinum-based chemotherapy

Interventions

Nivolumab + platinum-based chemotherapy DRUG

According to the product label

Also known as: Opdivo, Cisplatin, Carboplatin, Pemetrexed, Paclitaxel, Gemcitabine.

Cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of adults diagnosed with resectable non-small cell lung cancer (NSCLC) and have undergone neoadjuvant treatment with nivolumab in combination with platinum-based chemotherapy according to routine clinical practice in Argentina between 1st July 2022 and 1st March 2025

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Grupo Argentino Oncología Torácica (GAOT) - Asociación Argentina Oncología Clínica (AAOC): collaborator
• Bristol-Myers Squibb: lead

Study Sites (1)

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

Buenos Aires, C1426CPU, Argentina

Location

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Nivolumab; Platinum Compounds; Cisplatin; Carboplatin; Pemetrexed; Paclitaxel; Gemcitabine

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Coordination Complexes; Organic Chemicals; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Aldo Perfetti, MD

  Asociación Argentina Oncología Torácica (AAOC)

  PRINCIPAL INVESTIGATOR

• Bristol Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: August 26, 2025
• Study Start: May 26, 2025
• Primary Completion: November 18, 2025
• Study Completion: November 18, 2025
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)