Evaluation of FLT-PET and DWI-MRI in Patients With NSCLC Treated With a Platinum-based Doublet as Preoperative Chemo (EVIDENCE)

This is an interventional basic science trial for Non-small Cell Lung Carcinoma focused on measuring FLT-PET, DWI-MRI Read More

Inclusion Criteria:

• Age ≥ 18 years
• WHO performance status 0-1 (Appendix C)
• Histologically or cytological confirmed clinical stage II-IIIA non-small cell lung carcinoma (NSCLC), according to 7th TNM classification (Appendix D) (NOTE: patients with resectable N2 disease are also eligible)
• Baseline standard imaging assessment & staging should be performed within 6 weeks prior to planned treatment start.

• Patients must be candidate for curative intent surgery, and must be expected to complete the treatment.

  ♦♦ Adequate hematology and biochemical investigations, (should be done maximum 6 weeks before treatment starts)

• Normal bone marrow function based on routine blood samples, i.e. neutrophils ≥ 1.5 x 109/L, platelets ≥ 75 x 109/L, hemoglobin ≥ 10.0 g/dL
• Normal kidney function creatinine clearance ≥ 60 mL/min,
• Normal liver function assessed by routine laboratory examinations, i.e. bilirubin < 1.5 x upper limit of normal (ULN), ALT< 3 x ULN
• Patients must not have any contraindication for 18F-FLT-PET/CT or MRI procedures.
• Patient primary lung tumor larger than 20 mm in diameter (measured by diagnostic CT or MRI).
• Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test before trial registration.
• Patients of childbearing / reproductive potential should use adequate birth control measures, as defined by the investigator, during the study treatment period and for at least 6 months after the last study procedure. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly.
• Female subjects who are breast feeding should discontinue nursing before trial registration.
• Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.

Exclusion Criteria:

• Prior or current anticancer treatment for NSCLC, pre-operative therapy will include only chemotherapeutic drugs (pemetrexed is contraindicated), no other biological, targeted or radiotherapy is allowed
• Treatment with any investigational drug substance within 4 weeks prior to registration.
• Other malignancies in the 3 years prior to study entry with the exception of surgically cured carcinoma in situ of the cervix, in situ breast cancer, incidental finding of stage T1a or T1b prostate cancer, and basal/squamous cell carcinoma of the skin
• Evidence of any medical condition which would impair the ability of the patient to participate in the trial or might preclude therapy with chemotherapeutic drugs according to routine medical practice (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease, known dihydropyrimidine dehydrogenase deficiency, active infection, uncontrolled diabetes mellitus; uncontrolled arterial hypertension, history of unstable myocardial infarction)
• Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before randomization in the trial.