Metabolic Biomarkers Predicting Response to Neoadjuvant Immunotherapy in Non-Small Cell Lung Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
This study investigates metabolic glycolytic biomarkers obtained from radiological imaging (18F-FDG PET/CT), immunohistochemistry (IHC), and molecular analyses, and their association with response to neoadjuvant immunotherapy in early-stage non-small cell lung cancer (NSCLC). Objective: To evaluate the relationship between glycolytic biomarkers measured by PET/CT (metabolic tumor volume and SUVmax), IHC markers (GLUT-1, Ki-67, PD-L1), and molecular oncogenic alterations, with the pathological response after two cycles of neoadjuvant nivolumab (3 mg/kg) combined with platinum-based chemotherapy in patients with early-stage NSCLC \[stage IB (tumor ≥4 cm) to IIIA\], negative for EGFR and ALK mutations. Methods: This is a prospective, single-arm clinical study at a single institution, enrolling 30 patients. Baseline metabolic tumor volume (MTV) and SUVmax will be measured by PET/CT, while IHC markers and molecular profiling will be performed on pre-treatment biopsy samples. Patients will receive neoadjuvant treatment with nivolumab (3 mg/kg, IV) combined with platinum-based chemotherapy (cisplatin 75 mg/m² or carboplatin AUC 5, plus pemetrexed 500 mg/m² for non-squamous or paclitaxel 175 mg/m² for squamous tumors) every 21 days for two cycles. All patients will undergo invasive mediastinal staging before treatment and will be treated with robotic-assisted anatomical lung resection and mediastinal lymphadenectomy after neoadjuvant therapy. Primary outcomes include major pathological response (≤10% viable tumor cells) and immune profile characterization (IHC for CD8, CD4, FOXP3, PD-1, CD68, CD163). Secondary outcomes include event-free survival and treatment toxicity. Standard of Care: Neoadjuvant chemotherapy regimens and PET/CT scans are part of the institutional standard of care for NSCLC patients. Conclusion: The study aims to develop a practical diagnostic approach using metabolic glycolytic biomarkers to improve selection of patients likely to benefit from neoadjuvant immunotherapy. It is expected that patients with lower glycolytic activity will have higher rates of major pathological response after two cycles of neoadjuvant nivolumab (3 mg/kg) combined with chemotherapy. These findings may support a more cost-effective immunotherapy regimen for early-stage NSCLC.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Potwierdzony histologicznie rak płuca typu nie-drobnokomórkowy (NSCLC), stopień zaawansowania IB-IIIA
- •Guz może być bezpiecznie usunięty w opinii zespołu lekarzy
- •Stan ogólny pacjenta oceniany na 0-1 w skali ECOG (może się poruszać, wykonywać codzienne czynności)
- •Prawidłowe wyniki badań krwi i funkcji wątroby/nerek
- •Zdolność do zrozumienia i podpisania zgody na udział w badaniu
✗ Disqualifies
- •Wcześniejsze leczenie raka płuca chemioterapią, radioterapią lub inną immunoterapią
- •Mutacje EGFR lub ALK w guzie
- •Aktywna choroba autoimmunologiczna wymagająca leczenia w ciągu ostatnich 2 lat
- •Niekontrolowane inne choroby lub aktywne infekcje
- •Ciąża lub karmienie piersią
- •Medical przeciwwskazania do operacji lub znieczulenia
- •Inny nowotwór w ciągu ostatnich 3 lat (z wyjątkiem raka skóry lub nowotworu szyjki macicy we wczesnym stadium)
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- September 17, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (HC-FMRP-USP)
Ribeirão Preto, Brazil
Trial contact
Saulo B Silva, Associate Professor, MD, PhD
Federico EG Cipriano, MD, PhD
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/18/2026.
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