AZD6244 in Combination With Docetaxel Versus Docetaxel Alone in KRAS Mutation Positive NSCLC Patients
Recruiting in Palo Alto (17 mi)
+52 other locations
DP
Overseen byDr. Pasi Janne
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: AstraZeneca
Prior Safety Data
Trial Summary
What is the purpose of this trial?
The purpose of this study is to compare the efficacy of AZD6244 in combination with docetaxel versus docetaxel alone in patients with KRAS mutation positive locally advanced or metastatic non small cell lung cancer.
Research Team
DP
Dr. Pasi Janne
Principal Investigator
Dana-Farber Cancer Institute, Boston, USA
DG
Dr. Gabriella Mariani
Principal Investigator
AstraZeneca, Hertfordshire, UK
Eligibility Criteria
Inclusion Criteria
Locally advanced or metastatic non small cell lung cancer (IIIB-IV)
Failure of first line anti-cancer therapy (either radiological documentation of disease progression or due to toxicity) in advanced disease or subsequent relapse of disease following first line therapy
Tumour sample confirmed as KRAS mutation positive (Note: Sample must be available upon enrolment to ship to AZ appointed central laboratory, or mutation status confirmed locally at AstraZeneca agreed local laboratory using agreed methodology, or mutation status confirmed by an accredited (eg CLIA certified) commercial laboratory (eg Genzyme or Lab 21).
Treatment Details
Interventions
- AZD6244 (MEK Inhibitor)
- Docetaxel (Chemotherapy)
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: AZD6244 + DocetaxelActive Control2 Interventions
AZD6244 75 mg bd + Docetaxel 75 mg/m\^2
Group II: Placebo + DocetaxelPlacebo Group2 Interventions
Placebo + Docetaxel 75 mg/m\^2
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Research SiteBoston, MA
Research SiteOttawa, Canada
Research SiteColumbus, OH
Research SiteOshawa, Canada
More Trial Locations
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Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Trials
4491
Patients Recruited
290,540,000+