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

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)

Study Overview

• Status: Completed
• Conditions: Non-small Cell Lung Cancer (NSCLC)
• Intervention / Treatment: Drug: Nivolumab + platinum-based chemotherapy

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.

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1426CPU
    • Grupo Argentino Oncología Torácica (GAOT) - Asociación Argentina Oncología Clínica (AAOC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; According to the product label; Other Names: Opdivo, Cisplatin, Carboplatin, Pemetrexed, Paclitaxel, Gemcitabine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Event-free survival (EFS)	Defined as the time from the start of neoadjuvant therapy to the occurrence of any progression of disease precluding surgery, progression or recurrence of disease after surgery, progression of disease in the absence of surgery, or death from any cause	Up to 1 year
Rate of major pathological response (MPR) post-surgery	Proportion of patients with less than 10% residual viable tumor after neoadjuvant therapy, assessed at surgery.	Up to 1 year
Participant demographics	Socio-demographic characteristics of patients, such as age, sex and tobacco use.	Baseline
Participant clinical characteristics	Clinical characteristics of patients, describing the proportion and characteristics of patients who receive adjuvant RT and/or CT as subsequent treatment, and assessing surgical outcomes and adverse events (AEs)	Baseline
Number of participants receiving surgery	Number of patients receiving surgery after neoadjuvant treatment	Up to 1 year
Time from diagnosis to neoadjuvant treatment start before surgery	Discrete dates difference	Up to 1 year
Number of nivolumab doses received before surgery	Continues variable	Up to 1 year
Type of chemotherapy given in combination to nivolumab adjuvant treatment before surgery	Drugs received: Cisplatin, Carboplatin Pemetrexed, Paclitaxel, Gemcitabine	Up to 1 year
Relapse status	Date of investigator-assessed relapse and type of relapse (Locoregional, Distant)	Up to 1 year
Surgery type	Surgical approach (thoracotomy, VATS or robotic thoracic surgery) and surgical procedure type (lobectomy, segmentectomy, wedge resection, or pneumonectomy) will be recorded at the time of surgery.	Up to 1 year
Extent of surgical resection	R0, R1, R2	Up to 1 year
Surgical complications during or after surgery	Pre-established categories or categories formed based on free-text information available.	Up to 1 year
Reasons for not having surgery	ECOG Performance Status > 1, Major associated pathologies that increase the surgery risk to an unacceptable level, Disease progression, Adverse event Toxicity, Patient refusal, Poor lung function, Unresectability, Death, Others	Up to 1 year
Treatment received after neoadjuvant treatment	Treatment subsequent to neoadjuvant therapy, including radiotherapy, chemotherapy, immuno-oncology therapy, targeted therapy, or other treatments, will be recorded with treatment start and end dates during follow-up.	Up to 1 year
Reason for having adjuvant treatment	Pre-established categories or categories formed based on free-text information available	Up to 1 year
Adverse events (AEs)	Describe the frequency and severity of AEs and IMAEs, including intensity, seriousness, causality, preferred terms, organ class and event outcome. Analyses will be performed at both patient-level and at event-level overall, by intensity and by causality. For the patient-level analysis, patients will be counted once by AE considering the maximum grade.	Up to 1 year

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Collaborators: Grupo Argentino Oncología Torácica (GAOT) - Asociación Argentina Oncología Clínica (AAOC)
• Investigators: Study Director: Bristol Myers Squibb, Bristol-Myers Squibb; Principal Investigator: Aldo Perfetti, MD, Asociación Argentina Oncología Torácica (AAOC)

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2025
• Primary Completion (Actual): November 18, 2025
• Study Completion (Actual): November 18, 2025

Study Registration Dates

• First Submitted: August 19, 2025
• First Submitted That Met QC Criteria: August 19, 2025
• First Posted (Estimated): August 26, 2025

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Non-small cell lung cancer (NSCLC)
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Coordination Complexes; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Taxoids; Cyclodecanes; Diterpenes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Nivolumab; Pemetrexed; Gemcitabine; Carboplatin; Paclitaxel; Cisplatin; Platinum Compounds
• Other Study ID Numbers: CA209-1524

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No