Conditions: Adenocarcinoma of the Lung
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 130
Healthy volunteers: no

Brief summary:
The primary objective of this study is to compare the effect of farletuzumab versus placebo in combination with either a platinum agent (carboplatin) with paclitaxel or a platinum agent (carboplatin or cisplatin) with pemetrexed followed by farletuzumab or placebo on investigator-assessed progression free survival (PFS) as determined by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 or definitive clinical disease progression (eg, new occurrence of positive fluid cytology) in chemotherapy naive participants with folate receptoralpha (FRA)-expressing Stage IV adenocarcinoma of the lung.

Detailed description:

Arms:
arm 1: During Combination Therapy, farletuzumab will be given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6, cycles. Participants who experience clinical benefit from the Combination Therapy will enter the Monotherapy Phase and receive farletuzumab as monotherapy until disease progression. arm 2: During Combination Therapy, placebo will be given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6 cycles. Participants who experience clinical benefit from the Combination Therapy will enter the Monotherapy Phase and receive placebo as monotherapy until disease progression.

Interventions: intervention 1: Farletuzumab intervention 2: Placebo intervention 3: Carboplatin intervention 4: Paclitaxel intervention 5: Pemetrexed intervention 6: Cisplatin
Intervention descriptions: intervention 1: Combination Therapy: Farletuzumab 7.5 mg/kg will be administered intravenously on Cycle 1, Week 1 and Cycle 1, Week 2 (loading dose). Beginning on Cycle 2, Week 1, farletuzumab (7.5 mg/kg) will be administered intravenously on Week 1 of all additional cycles.

Monotherapy: Farletuzumab 7.5 mg/kg will be administered intravenously on Week 1 of every 3-week cycle until disease progression. intervention 2: Combination Therapy: Placebo will be administered intravenously on Cycle 1, Week 1 and Cycle 1, Week 2 (loading dose). Beginning on Cycle 2, Week 1, placebo will be administered IV on Week 1 of all additional cycles.

Monotherapy: Placebo will be administered intravenously on Week 1 of every 3-week cycle until disease progression. intervention 3: Carboplatin will be administered intravenously to achieve area under the serum concentration-time curve of 5 to 6 mg/mL\^min \[AUC5-6\]. intervention 4: Paclitaxel 200 mg/m\^2 will be administered intravenously. intervention 5: Pemetrexed 500 mg/m\^2 will be administered intravenously. intervention 6: Cisplatin 75 mg/m\^2 will be administered intravenously.

Protocol document: