Efficacy Analysis of Neoadjuvant Treatment in Lung Cancer Using Low-dose Nivolumab Combined With Chemotherapy

Efficacy Analysis of Neoadjuvant Treatment in Lung Cancer Using Low-Dose Nivolumab Combined With Chemotherapy

Efficacy Analysis of Neoadjuvant Treatment in Lung Cancer Using Low-dose Nivolumab Combined With Chemotherapy (NCT06667154) is a Phase 2 interventional studying Lung Cancer, Nonsmall Cell and Non-Small Cell Lung Cancer NSCLC, sponsored by Aline Fusco Fares, Md. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Lung Cancer, Nonsmall Cell and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 33 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - Able to provide a signed willing to sign a consent form Form (ICF), indicating agreement to comply with the requirements and restrictions in the ICF and protocol. - Male or female, aged 18 years or older. - Diagnosed with non-small cell lung cancer (NSCLC) with clinical staging IB, II, or IIIA. - Receiving treatment at Hospital de Base. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment, with no decline from two weeks prior to the baseline period or the day of the first dose. - Tumor sample meets the following requirements: - Negative for EGFR gene expression. - Negative for ALK and ROS1 protein expression. - PD-L1 protein expression documented and assessable. - Tumor is considered resectable upon initial assessment by three thoracic oncology surgeons (IR, CM, and HN) following a multidisciplinary review. - Adequate organ and bone marrow function as defined below: - Hemoglobin: ≥ 9.0 g/dL\* - Absolute neutrophil count: ≥ 1.5 × 10\^9 /L\* - Platelet count: ≥ 100 × 10\^9 /L\* - \*Note: Granulocyte colony-stimulating factor (G-CSF), platelet transfusions, and blood transfusions are not permitted to meet these values. - Serum bilirubin: ≤ 1.5 × upper limit of normal (ULN), except for participants with confirmed Gilbert syndrome, who may be included upon physician consultation. - ALT and AST: ≤ 2.5 × ULN. - Creatinine clearance: ≥ 50 mL/min (calculated using the Cockcroft and Gault formula). - Life expectancy greater than six months prior to randomization. Who Should NOT Join This Trial: - Refusal to sign the willing to sign a consent form Form (ICF). - NSCLC clinical stages IA, IIIB N3, IIIC, IVA, and IVB. - Tumors with T4 invasion of the aorta, esophagus, and/or heart; or presence of bulky N2 disease. - Tumor deemed unresectable. - Prior systemic anticancer therapy for NSCLC, including chemotherapy, biologic therapy, immunotherapy, or any investigational drugs. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Able to provide a signed Informed Consent Form (ICF), indicating agreement to comply with the requirements and restrictions in the ICF and protocol. * Male or female, aged 18 years or older. * Diagnosed with non-small cell lung cancer (NSCLC) with clinical staging IB, II, or IIIA. * Receiving treatment at Hospital de Base. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment, with no decline from two weeks prior to the baseline period or the day of the first dose. * Tumor sample meets the following requirements: * Negative for EGFR gene expression. * Negative for ALK and ROS1 protein expression. * PD-L1 protein expression documented and assessable. * Tumor is considered resectable upon initial assessment by three thoracic oncology surgeons (IR, CM, and HN) following a multidisciplinary review. * Adequate organ and bone marrow function as defined below: * Hemoglobin: ≥ 9.0 g/dL\* * Absolute neutrophil count: ≥ 1.5 × 10\^9 /L\* * Platelet count: ≥ 100 × 10\^9 /L\* * \*Note: Granulocyte colony-stimulating factor (G-CSF), platelet transfusions, and blood transfusions are not permitted to meet these values. * Serum bilirubin: ≤ 1.5 × upper limit of normal (ULN), except for participants with confirmed Gilbert syndrome, who may be included upon physician consultation. * ALT and AST: ≤ 2.5 × ULN. * Creatinine clearance: ≥ 50 mL/min (calculated using the Cockcroft and Gault formula). * Life expectancy greater than six months prior to randomization. Exclusion Criteria: * Refusal to sign the Informed Consent Form (ICF). * NSCLC clinical stages IA, IIIB N3, IIIC, IVA, and IVB. * Tumors with T4 invasion of the aorta, esophagus, and/or heart; or presence of bulky N2 disease. * Tumor deemed unresectable. * Prior systemic anticancer therapy for NSCLC, including chemotherapy, biologic therapy, immunotherapy, or any investigational drugs. * History of another primary malignancy, with exceptions for: * Malignancies treated with curative intent and no active disease for ≥ 2 years before the first dose of investigational product (IP) and with a low risk of recurrence. * Adequately treated non-melanoma skin cancer or lentigo maligna with no evidence of disease. * Adequately treated carcinoma in situ with no evidence of disease. * Incomplete basic medical information in the electronic medical record. * Positive for EGFR gene expression. * Positive for ALK protein expression. * No available data on PD-L1 protein expression. * Positive for ROS1 protein expression. * Pregnant or breastfeeding at the time of enrollment.

Treatments Being Tested

DRUG

Low-dose nivolumab combined with platinum-based doublet chemotherapy

Platinum-based neoadjuvant chemotherapy (carboplatin at AUC 5 or 6 combined with either paclitaxel at 175 mg/m² or pemetrexed at 500 mg/m²), administered with nivolumab at 0.3 mg/kg every 21 days for 3 cycles.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto

São José do Rio Preto, São Paulo, Brazil

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06667154), the sponsor (Aline Fusco Fares, Md), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06667154 clinical trial studying?

The primary objective of this study is to assess the major pathological response (MPR) rate and pathologic complete response (pCR) rate in stage IB-IIIA non-small cell lung cancer (NSCLC) treated with a low dose of neoadjuvant immunotherapy combined with platinum doublet. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06667154?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06667154?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06667154. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06667154. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.