Phase 2
N=130
A Safety and Efficacy Study of Farletuzumab in Participants With Adenocarcinoma of the Lung
Adenocarcinoma of the Lung
Bottom Line
View on ClinicalTrials.gov: NCT01218516 ↗Enrolled (actual)
130
Serious AEs
34.4%
Results posted
Aug 2020
Primary outcome: Primary: Progression-free Survival (PFS) — 5.8; 4.7; 5.9; 4.7 Months — p=0.3519
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Farletuzumab (Biological); Placebo (Other); Carboplatin (Drug); Paclitaxel (Drug); Pemetrexed (Drug); Cisplatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Morphotek
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival (PFS) |
5.8; 4.7; 5.9; 4.7 | 0.3519 |
| SECONDARY Overall Response Rate (ORR) |
37.3; 41.3 | — |
| SECONDARY Duration of Response (DR) |
6.7; 4.1 | — |
| SECONDARY Overall Survival (OS) |
10.5; 14.1 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs) |
60; 63; 30; 25; 27; 27 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT01218516). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.