Tests low-dose nivolumab with chemotherapy before surgery for lung cancer
Tests low-dose nivolumab with chemotherapy before surgery in non-small cell lung cancer.
Plain-language title generated from the registry record
Registry title: Efficacy Analysis of Neoadjuvant Treatment in Lung Cancer Using Low-dose Nivolumab Combined With Chemotherapy
Key facts
- Where
- São José do Rio Preto, BrazilSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with non-small cell lung cancer at stage IB, II or IIIA, whose tumor can be removed by surgery and who have had no earlier cancer drug treatment.
- Age
- 18 years or older
- Sex
- Women and men can join
- Disease stage
- Non-small cell lung cancer, clinical stage IB, II or IIIA, judged resectable (can be removed by surgery) after review by three thoracic oncology surgeons
- Earlier treatment
- No earlier whole-body (systemic) cancer treatment for this lung cancer, such as chemotherapy, immunotherapy or investigational drugs
- Biomarker or test result
- Tumor sample negative for EGFR, ALK and ROS1; PD-L1 result documented and measurable
Main reasons for not taking part
- Cancer stage IA, IIIB N3, IIIC, IVA or IVB
- Tumor that cannot be removed by surgery
- Earlier systemic cancer treatment for this lung cancer
- Another cancer in the past, with a few exceptions
- Pregnant or breastfeeding
Read by machine on 12 November 2026.
Where in Brazil
- Fundacao Faculdade Regional de Medicina de Sao Jose do Rio PretoSão José do Rio Preto, BrazilContact: JOAO A SOLER, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Aline Fusco Fares, MD
- Trial code
- NCT06667154
- Record updated
- 31 October 2024
- Original description
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.Read full original descriptionShow less
Efficacy Analysis of Neoadjuvant Treatment in Lung Cancer Using Low-Dose Nivolumab Combined With Chemotherapy
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.
Inclusion: 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: Prior systemic anticancer therapy for NSCLC, including chemotherapy, biologic therapy, immunotherapy, or any investigational drugs; 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; Tumors with T4 invasion of the aorta, esophagus, and/or heart; or presence of bulky N2 disease; History of another primary malignancy, with exceptions for:; Adequately treated non-melanoma skin cancer or lentigo maligna with no evidence of disease; Adequately treated carcinoma in situ with no evidence of disease; Positive for EGFR gene expression; Refusal to sign the Informed Consent Form (ICF); NSCLC clinical stages IA, IIIB N3, IIIC, IVA, and IVB; Tumor deemed unresectable; Incomplete basic medical information in the electronic medical record; 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.