Nivolumab and Ipilimumab Plus Chemotherapy for Patients With Stage IV Lung Cancer With Brain Metastases

"Patients will receive Ipilimumab 1mg/Kg administered by IV infusion every 42 days (Q6W) until disease progression, unacceptable toxicity, loss of clinical benefit as judged by the investigator or up to a maximum of 2 years of treatment.~Structure: is a fully human monoclonal antibody with two heavy chains and two kappa light chains linked together by way of disulfide bonds. The molecular weight is approximately 148 kDa and it exists in solution at a physiologic pH of 7.0.~Route of administration: Intravenous infusion."

"Patients will receive Nivolumab 360 mg administered by IV infusion every 21 days (Q3W) until disease progression, unacceptable toxicity, loss of clinical benefit as judged by the investigator or up to a maximum of 2 years of treatment.~Structure: Nivolumab is a soluble protein consisting of 4 polypeptide chains, which include 2 identical heavy chains and 2 identical light chains.~Route of administration: Intravenous infusion."

"Patients will receive Carboplatin AUC 5 or 6 administered by IV infusion every 21 days (Q3W), for 2 cycles.~Structure: The cis-diamino (cyclobutane-1, 1 dicarboxylate) platin. Stability: 24 hours at ambient temperature in 5% glucose, glucosa or physiologic saline. It is recommended not to dilute with chlorinated solutions since this could affect the carboplatin.~Route of administration: Intravenous infusion. Guidelines of Carboplatin administration: According to the standard of each center."

"Patients will receive Cisplatin 75mg/m2 administered by IV infusion every 21 days (Q3W), for 2 cycles.~Structure: (CAS No. 15663-27-1, MF-Cl2H6N2Pt; NCF-119875), cisplatinum, also called cis-diamminedichloroplatinum(II), is a metallic (platinum) coordination compound with a square planar geometry. It is a white or deep yellow to yellow-orange crystalline powder at room temperature.~Stability: Do not store above 25°C. Do not refrigerate or freeze. Keep container in the outer carton to protect from light. Following dilution in 0.9% sodium chloride injection, chemical and physical in-use stability has been demonstrated for up to 14 days at 20°C.~Route of administration: Intravenous infusion. Guidelines of Cisplatin administration: According to the standard of each center."

"Patients will receive Paclitaxel 200mg/m2 administered by IV infusion every 21 days (Q3W), for 2 cycles.~Structure: A diterpene whose composition is: 5b, 20-epoxy-1, 2a, 4,7b, 10b, 13a-hexahidroxytax-11-en 9 one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)- N-benzoyl-3-phenylisoserine.~Stability: Concentrations of 0.3-1.2 mg/ml in 5% dextrose or normal saline have demonstrated chemical and physical stability for more that 27 hours at ambient temperature (25ºC approximately). The intact vial must be stored between 15º and 25ºC.~Guidelines of Paclitaxel administration: Paclitaxel must be administered by infusion over 3 hours in dextrose (D5W) or normal saline (NS). The concentration must not exceed 1.2 mg/ml."

"Patients will receive Pemetrexed 500mg/m2 administered by IV infusion every 21 days (Q3W), for 2 cycles.~Structure: Pemetrexed disodium (ALIMTA®, pemetrexed) is a novel pyrrol \[2,3 d\]-pyrimidine based folic acid analogue.~Route of administration: Intravenous infusion. Guidelines of Pemetrexed administration: According to the standard of each center"