Non-small Cell Lung Cancer (NSCLC)NCT07141563
A Study Describing Real-World Effectiveness of Nivolumab + Chemotherapy in Neoadjuvant NSCLC
An observational study of Non-small Cell Lung Cancer (NSCLC), run by Bristol-Myers Squibb at 1 site in Argentina.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer (NSCLC)
- What is being tested?
- Nivolumab + platinum-based chemotherapy
- How many people
- 70 participants
- Where
- 1 siteArgentina
- Study dates
- 26 May 2025to 18 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Grupo Argentino Oncología Torácica (GAOT) - Asociación Argentina Oncología Clínica (AAOC)
Buenos Aires, C1426CPU
About this study
Official title: 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)
Read the 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)
- Being tested
- Nivolumab + platinum-based chemotherapy
- Keywords
- Non-small cell lung cancer (NSCLC)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nivolumab + platinum-based chemotherapyDrug
Also called Opdivo, Cisplatin, Carboplatin, Pemetrexed, Paclitaxel, Gemcitabine.
According to the product label
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Participants with resectable non-small cell lung cancer (NSCLC) receiving neoadjuvant treatment with nivolumab in combination with platinum-based chemotherapy Receives: Drug: Nivolumab + platinum-based chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 1 year
Secondary outcomes (16)
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
Measured: 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.
Measured: Up to 1 year
Participant demographics
Socio-demographic characteristics of patients, such as age, sex and tobacco use.
Measured: 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)
Measured: Baseline
Number of participants receiving surgery
Number of patients receiving surgery after neoadjuvant treatment
Measured: Up to 1 year
Time from diagnosis to neoadjuvant treatment start before surgery
Discrete dates difference
Measured: Up to 1 year
Number of nivolumab doses received before surgery
Continues variable
Measured: Up to 1 year
Type of chemotherapy given in combination to nivolumab adjuvant treatment before surgery
Drugs received: Cisplatin, Carboplatin Pemetrexed, Paclitaxel, Gemcitabine
Measured: Up to 1 year
Relapse status
Date of investigator-assessed relapse and type of relapse (Locoregional, Distant)
Measured: 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.
Measured: Up to 1 year
Extent of surgical resection
R0, R1, R2
Measured: Up to 1 year
Surgical complications during or after surgery
Pre-established categories or categories formed based on free-text information available.
Measured: 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
Measured: 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.
Measured: Up to 1 year
Reason for having adjuvant treatment
Pre-established categories or categories formed based on free-text information available
Measured: 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.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start26 May 2025
- Primary completion18 Nov 2025
- Study completion18 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Grupo Argentino Oncología Torácica (GAOT) - Asociación Argentina Oncología Clínica (AAOC)
- Responsible party
- Sponsor
- Investigators
- Aldo Perfetti, MD, Principal investigator, Asociación Argentina Oncología Torácica (AAOC)Bristol Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07141563
- Sponsor's protocol ID
- CA209-1524
- Status last verified
- Jan 2026
- First submitted
- 19 Aug 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study for Describing Real-World Effectiveness of Nivolumab + Chemotherapy in Neoadjuvant NSCLC in Argentina
- ClinicalTrials.gov ID
- NCT07141563
- Acronym / sponsor ID
- CA209-1524
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Keywords
- Non-small cell lung cancer (NSCLC)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Grupo Argentino Oncología Torácica (GAOT) - Asociación Argentina Oncología Clínica (AAOC)
- Study start
- 26 May 2025 (actual)
- Primary completion
- 18 Nov 2025 (actual)
- Study completion
- 18 Nov 2025 (actual)
- First posted
- 26 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Drug: Nivolumab + platinum-based chemotherapyParticipants with resectable non-small cell lung cancer (NSCLC) receiving neoadjuvant treatment with nivolumab in combination with platinum-based chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nivolumab + platinum-based chemotherapyAlso: Opdivo, Cisplatin, Carboplatin, Pemetrexed, Paclitaxel, Gemcitabine.According to the product label | Drug | Cohort 1 |
Primary outcome
Rate of pathological complete response (pCR) post-surgery
Time frame: Up to 1 year
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.
16 secondary outcomes
Event-free survival (EFS)
Time frame: Up to 1 year
Rate of major pathological response (MPR) post-surgery
Time frame: Up to 1 year
Participant demographics
Time frame: Baseline
Participant clinical characteristics
Time frame: Baseline
Number of participants receiving surgery
Time frame: Up to 1 year
Time from diagnosis to neoadjuvant treatment start before surgery
Time frame: Up to 1 year
Number of nivolumab doses received before surgery
Time frame: Up to 1 year
Type of chemotherapy given in combination to nivolumab adjuvant treatment before surgery
Time frame: Up to 1 year
Relapse status
Time frame: Up to 1 year
Surgery type
Time frame: Up to 1 year
Extent of surgical resection
Time frame: Up to 1 year
Surgical complications during or after surgery
Time frame: Up to 1 year
Reasons for not having surgery
Time frame: Up to 1 year
Treatment received after neoadjuvant treatment
Time frame: Up to 1 year
Reason for having adjuvant treatment
Time frame: Up to 1 year
Adverse events (AEs)
Time frame: Up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aldo Perfetti, MD principal investigator
Asociación Argentina Oncología Torácica (AAOC)
Bristol Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer (NSCLC), run by Bristol-Myers Squibb at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of pathological complete response (pCR) post-surgery (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.