CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Etirinotecan pegol (NKTR-102)drug
Likely dose
Etirinotecan pegol (NKTR-102) 145 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01773109
NCT01773109Phase 2Completed
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Phase 2 Study of Etirinotecan Pegol (NKTR-102) in the Treatment of Patients With Metastatic and Recurrent Non-Small Cell Lung Cancer (NSCLC) After Failure of 2nd Line Treatment

Abramson Cancer Center at Penn Medicine·interventional·Posted Jan 23, 2013·Updated Apr 3, 2020

In Brief

A Phase 2 clinical trial evaluating Etirinotecan pegol (NKTR-102) for Metastatic Non Small Cell Lung Cancer and Recurrent Non Small Cell Lung Cancer. Completed, enrolled 40 participants across 1 site.

Detailed Summary

This Phase 2 study is designed to characterize the objective response rate (defined as complete response (CR) and partial response (PR)) of Etirinotecan pegol administered to subjects with metastatic and recurrent NSCLC after failure of 2nd line therapy. Up to 37 eligible subjects will receive the investigational drug q3 weeks until they are no longer benefiting.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Non Small Cell Lung Cancer, Recurrent Non Small Cell Lung Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 23, 2013
Enrollment StartJan 1, 2013
Primary CompletionJan 1, 2016
Study CompletionMar 15, 2017
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 13.4 years ago

Interventions

Etirinotecan pegol (NKTR-102)drug

Eligible patients will receive etirinotecan pegol at a dose of 145 mg/m2 iv every 3 weeks. One cycle will be defined as 3 weeks. Treatment will be administered on an outpatient basis.