A Safety and Efficacy Study of Farletuzumab in Participants With Adenocarcinoma of the Lung

Morphotek

Status and phase: Completed; Phase 2

Conditions: Adenocarcinoma of the Lung

Treatments: Drug: Cisplatin; Drug: Pemetrexed; Drug: Carboplatin; Biological: Farletuzumab; Drug: Paclitaxel; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01218516

2010-022229-13 (EudraCT Number)

MORAb-003-009

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically confirmed adenocarcinoma of the lung classified as stage IV
• Confirmed folate receptor-alpha (FRA) expression by immunohistochemistry (IHC)
• Measurable disease with at least one unidimensionally measurable lesion according to RECIST criteria version 1.1 by computed tomography (CT) or magnetic resonance imaging (MRI) scans (CT or MRI scans must have been performed within 30 days prior to the first dose of farletuzumab or placebo)
• Must have received no prior chemotherapy, radiation therapy or surgery with curative intent for adenocarcinoma of the lung

Exclusion criteria

• Participants who have had previous chemotherapy for adenocarcinoma of the lung
• Prior surgery with curative intent for adenocarcinoma of the lung
• Prior radiotherapy for adenocarcinoma of the lung. (Prior treatment with local radiotherapy for symptom control [i.e., palliative radiation with non-curative intent] is permitted)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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130 participants in 2 patient groups, including a placebo group

Farletuzumab plus Chemotherapy

Active Comparator group

Description:

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.

Treatment:

Drug: Carboplatin

Biological: Farletuzumab

Drug: Cisplatin

Drug: Pemetrexed

Drug: Paclitaxel

Placebo plus Chemotherapy

Placebo Comparator group

Description:

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.

Treatment:

Drug: Carboplatin

Drug: Cisplatin

Drug: Pemetrexed

Drug: Paclitaxel

Other: Placebo