A Phase II Study of First-Line Chemotherapy and Panitumumab in Advanced NSCLC Selected by Mutational Status
- Histologically confirmed metastatic (stage IV) NSCLC
- Measurable disease according to RECIST v.1.0 2009
- KRAS, BRAF and PI3K wild type in primary tumor or metastatic tissue.
- Age ≥18
- PS < 2
- Adequate organ function
- Neutrophil count ≥1.5x10^9/L
- Platelet count ≥100x10^9/L
- Leucocyte count > 3,000/mm
- Total bilirubin ≤ 1.5 times the upper normal limit (UNL)
- Serum transaminases ≤ 2.5xUNL in absence of liver metastases, or ≤ 5xUNL in presence
of liver metastases
- Creatinine clearance ≥ 50 mL/min and serum creatinine ≤ 1.5xUNL
- Magnesium ≥ lower limit of normal.
- Calcium ≥ lower limit of normal.
Consent to translational research studies
Written informed consent
- Clinically significant cardiovascular disease (including myocardial infarction,
unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac
arrhythmia) ≤ 1 year before enrollment/randomization, active severe infections or
other concurrent disease.
- Known CNS metastasis (pretreatment routine assessment not required)
- Prior chemotherapy for metastatic disease
- Indication for radiation therapy or prior radiotherapy within 30 days before
- Other malignant diseases within 5 years prior to inclusion in the study, except basal
cell squamous carcinoma of the skin and cervical carcinoma-in-situ.
- Other experimental therapy within 30 days prior to treatment initiation.
- History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or
evidence of interstitial lung disease on baseline chest CT scan.
- Patients pregnant or breast feeding, or planning to become pregnant within 6 months
after the end of treatment.
- Patients (male or female) not willing to use highly effective methods of
contraception (per institutional standard) during treatment and for 6 months (male or
female) after the end of treatment.