CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 192 enrolled
Drug / intervention
Necitumumab +2 moredrug
Likely dose
Not stated in 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/NCT01763788
NCT01763788Phase 2Completed
CompareCT.gov

An Open-Label, Multicenter, Phase 1b/2 Study to Evaluate Necitumumab in Combination With Gemcitabine and Cisplatin in the First-Line Treatment of Patients With Advanced (Stage IV) Squamous Non-Small Cell Lung Cancer (NSCLC)

Eli Lilly and Company·interventional·Posted Jan 9, 2013·Updated Oct 25, 2019

In Brief

A Phase 2 clinical trial evaluating Necitumumab, Gemcitabine, and 1 other intervention for Squamous Non-small Cell Lung Cancer. Completed, enrolled 192 participants across 20 sites.

Detailed Summary

The purpose of the Phase 1b portion of the study is to investigate how the body tolerates necitumumab, in combination with gemcitabine and cisplatin chemotherapy as first line treatment in participants with Stage IV squamous NSCLC and to determine the recommended dose for the subsequent Phase 2 portion of the study. The purpose of the Phase 2 portion of the study is to evaluate the efficacy of necitumumab in combination with gemcitabine and cisplatin chemotherapy in participants with Stage IV squamous NSCLC in a first-line setting.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSquamous Non-small Cell Lung Cancer
CountriesJapan
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 9, 2013
Enrollment StartMay 7, 2013
Primary CompletionJun 28, 2017
Study CompletionOct 17, 2018
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 13.5 years ago

Interventions

Necitumumabdrug

Administered IV

Gemcitabinedrug

Administered IV

Cisplatindrug

Administered IV