This phase I/IB trial aims to determine whether combining MEK162(ARRY-162) and erlotinib (Tarceva) is safe and effective at treating patients with stage IV non-small cell lung cancer (NSCLC) with KRAS or EGFR mutations and no curative treatment options. The main outcome of the trial will be maximum tolerated dose (MTD – highest dose of the drug that does not cause serious side effects) of MEK162 and erlotinib and survival rate of patients after 3 years. This trial is recruiting in Tampa, Florida.
The details
MEK and EGFR are proteins in the body that can be overactive in some cancers. These proteins stop programmed cell death, allowing the cancer cells to keep dividing. MEK162 is a treatment that inhibits (blocks) MEK. Erlotinib is a treatment that blocks EGFR. These treatments can therefore increase cancer cell death. MEK162 is a new drug that has not yet been approved by the FDA.
This trial will investigate whether MEK162 in combination with erlotinib is safe and effective at treating patients with advanced NSCLC with KRAS or EGFR mutations. This will be determined in terms of overall survival and progression free survival (time from beginning trial until disease progression or death).
Who are they looking for?
The trial is recruiting 44 patients with stage IV NSCLC. Pregnant of breastfeeding women will not be accepted and applicants must be willing to use contraception during the trial to avoid pregnancy. Patients with KRAS mutations must have had prior treatment, however any other cancer treatment must have been discontinued more than 14 days prior to the trial. Patients must also have recovered from any side effects to previous treatment more than 14 days before the trial and be willing to have a biopsy taken.
Patients must not have cancer that has spread to the central nervous system or brain unless it has been successfully treated previously. Patients with other serious uncontrolled medical conditions, such as heart problems, or active infection including HIV and hepatitis B or C will not be eligible for the trial. Prior treatment with MEK162 or recent major surgery is not accepted. Patients must not have a history or evidence of certain eye diseases including central serous retinopathy or retinal vein occlusion. Strenuous exercise must be avoided during the trial.
How will it work
Patients will be divided into two groups based on if they have KRAS or EGFR mutations. Patients will then be treated with MEK162, an oral drug, twice daily and erlotinib once daily for 28 day cycles. Patients will undergo follow-ups 6 months after treatment then again at 3 years after treatment.
