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Phase 2 Study of EC145 Alone Versus EC145+Docetaxel Versus Docetaxel Alone in Participants With FR(++) 2nd Line Non Small Cell Lung Cancer

NCT01577654 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 203

Last updated 2021-04-01

No results posted yet for this study

Summary

This study will test the activity of single-agent EC145 and the combination of EC145 plus docetaxel against the current standard docetaxel in second line Non Small Cell Lung Cancer (NSCLC) (adenocarcinoma, squamous, adenosquamous or adenocarcinoma with other NSCLC variants of the lung) in participants with all target lesions expressing the folate receptor \[FR(++)\].

Conditions

  • Non Small Cell Lung Cancer

Interventions

DRUG

EC145

2.5 mg on Days 1,4,8,11 (Weeks 1 and 2 q3 weeks)

DRUG

EC145 + Docetaxel

EC145 2.5 mg on Days 1,4,8,11 (Weeks 1 and 2 q3 weeks) + Docetaxel 75 mg/m2 IV Day 1 q 3 weeks

DRUG

Docetaxel

75 mg/m2 IV Day 1 q 3 weeks

DRUG

EC20

During the screening period participants will receive a single intravenous administration of EC20 prior to SPECT imaging

Sponsors & Collaborators

  • Endocyte

    lead INDUSTRY

Principal Investigators

  • Binh Nguyen, MD, PhD · Endocyte

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2013-12-31
Completion
2015-08-31

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01577654 on ClinicalTrials.gov