AZD6244 Versus Pemetrexed (Alimta®) in Patients With Non-small Cell Lung Cancer, Who Have Failed One or Two Prior Chemotherapy Regimen

A Phase II, Open, Randomised Study to Assess the Efficacy and Safety of AZD6244 Versus Pemetrexed (Alimta®) in Patients With Non-small Cell Lung Cancer, Who Have Failed One or Two Prior Chemotherapy Regimen

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00372788

Enrollment

Registered

2006-09-07

Start date

2006-08-31

Completion date

2008-12-31

Last updated

2014-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Keywords

NSCLC, Advanced Non-Small Cell Lung Cancer, AZD6244

Brief summary

The purpose of this study is to assess the effect and safety of AZD6244(ARRY-142886)versus pemetrexed in the second or third line treatment of advanced Non-Small Cell Lung Cancer. Following baseline assessments, a minimum of 64 patients in approximately 5-6 centers from the US will be treated with either AZD6244 or pemetrexed. Treatment will be continued for as long as patients receive clinical benefit.

Interventions

DRUGAZD6244

oral vial

DRUGPemetrexed

oral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Diagnosed with non-small cell lung cancer * Previously received one or two chemotherapeutic treatments

Exclusion criteria

* Previous therapy with MEK inhibitor or pemetrexed * Any recent surgery, unhealed surgical incision or severe condition such as uncontrolled cardiac disease or chronic gastrointestinal diseases

Design outcomes

Primary

Measure	Time frame
Assess tumor growth	assessed every 12 weeks

Secondary

Measure	Time frame
Assess safety and tolerability of AZD6244	assessed at each visit

Countries

Bulgaria, Romania, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026