Conditions: Non-small Cell Lung Cancer
Keywords: Stage IIIB/IV non-small cell lung cancer Non-small cell lung cancer NSCLC Lung Cancer Pralatrexate Erlotinib Tarceva PDX Smoking Smoker
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 201
Healthy volunteers: no

Brief summary:
The purpose of this clinical study is to determine the effectiveness (ability to provide beneficial treatment of the disease) and safety of pralatrexate compared to erlotinib when given to non-small cell lung cancer (NSCLC) patients who are current or former cigarette smokers and who have received at least 1 prior treatment with a platinum drug (cisplatin or carboplatin)

Detailed description:

Arms:
arm 1: Intravenous (IV) push administration over 3-5 minutes into a patent IV line containing normal saline (0.9% sodium chloride). arm 2: 150 mg orally in tablet form

Administered daily 1 hour before or 2 hours after ingestion of food until criteria for discontinuation per the protocol are met.

Interventions: intervention 1: Pralatrexate intervention 2: Erlotinib intervention 3: Vitamin B12 intervention 4: Folic Acid
Intervention descriptions: intervention 1: Intravenous (IV) push administration over 3-5 minutes into a patent IV line containing normal saline (0.9% sodium chloride).

Initial dose: 230 mg/m2, increased to 270 mg/m2 if patient does not have specific adverse events (AEs) as per the protocol after receipt of 2 consecutive doses 2 weeks apart. Reductions allowed in 40 mg/m2 decrements to 190 mg/m2 per the protocol defined dose modifications.

Protocol amended dose: 190 mg/m2, then 230 mg/m2 if patient does not have specific AEs per the protocol after receipt of 2 consecutive doses 2 weeks apart. Reductions allowed in 40 mg/2 decrements to 150 mg/m2 per the protocol defined dose modifications.

Administered on days 1 and 15 of a 4-week cycle (every 2 weeks) until criteria for discontinuation per the protocol are met. intervention 2: 150 mg orally in tablet form

Administered daily 1 hour before or 2 hours after ingestion of food until criteria for discontinuation per the protocol are met. intervention 3: 1 mg intramuscular injection

Administered within 10 weeks of randomization, every 8-10 weeks throughout the study and for at least 30 days after last dose of study treatment. intervention 4: 1-1.25 mg orally

Administered daily for at least 7 days prior to randomization, throughout the study and for at least 30 days after last dose of study treatment.

Protocol document: