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L-DOS47 Monotherapy in Non-Squamous NSCLC
NCT02340208Phase 2
Key facts
- Status
- Completed
- Start
- May 2012
- Primary completion
- Aug 2017
- Countries
- 1
- Sponsor
- Helix BioPharma
- Modality
- Antibody Fragments, Antibody-Drug Conjugates (ADCs), Replacement Enzymes
- Drugs
- L-DOS47
- Conditions
- Nonsquamous Non-Small Cell Lung Cancer (nsNSCLC)
01
Overview
Phase 2, open-label, single-arm trial of L-DOS47 in Nonsquamous Non-Small Cell Lung Cancer (nsNSCLC), sponsored by Helix BioPharma. Primary endpoint: Incidence and severity of drug-related adverse events up to 12 weeks. Started May 2012; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
L-DOS47
L-DOS47 monotherapy at escalating doses
03
Who it enrols
Adult patients with histologically confirmed non-squamous NSCLC who are either chemo-naive and not candidates for standard therapy or refractory to standard therapy, with adequate organ function and no CNS metastases.
04
Endpoints
Primary
Incidence and severity of drug-related adverse events
Secondary
L-DOS47 related toxicity during the first 2 hours after infusion
Incidence and severity of all reported adverse events and serious adverse events
Changes from baseline for additional safety parameters
Evaluation of anti-L-DOS47 antibody over time
Objective Response Rate
Progression-Free Survival
Overall Survival
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