Studieoverzicht

Study name: THORACIC: deTect patHological cOmplete Response following neoAdjuvant ChemoImmunotherapy in nsclC

Histology	NSCLC, all subtypes
Tumor stage	Stage I - III
Host / recruiting site 1	Antoni van Leeuwenhoek	Enrollment	Recruiting
Host / recruiting site 2	Amsterdam UMC	Enrollment	Planned
Host / recruiting site 3	Catharina Ziekenhuis	Enrollment	Recruiting
Therapy line	First line (1L)
PD-L1 expression	Negative: <1% , Low: 1 - 49% , High: ≥50%
Design	Prospective, observational, multicenter trial
Intervention	Blood sampling for (tumor-informed) ctDNA analysis. Optional: Metabolic MRI scan of the chest
Key outcome parameters	Discriminatory accuracy of the metabolic response on FDG-PET, clearance of ctDNA and PD-L1 expression the distinguish between pathological compete response (pCR) and non-pCR following neoadjuvant chemoimmunotherrapy
Key inclusion criteria	Pathologically proven NSCLC stage IIA – IIIB according to the 9th edition of the American Joint Commission on Cancer (AJCC) staging deemed resectable by the MDT. (baseline) histological tumor specimen OR ≥150 ng dsDNA tumor genomic DNA available Patient deemed operable by the multidisciplinary team meeting. Indication for neoadjuvant chemoimmunotherapy.
Key exclusion criteria	No baseline (within 8 weeks of inclusion) [18F]FDG-PET scan with EARL reconstruction. Only cytological baseline tumor material available Any condition that, in the opinion of the investigator, would interfere with evaluation of metabolic response evaluation or ctDNA analysis (i.e. second active malignancy)
Contact information	Log in voor de contactinformatie