Study on the Effectiveness and Safety of Selumetinib with Docetaxel for Second-Line Treatment in KRAS Positive Non-Small Cell Lung Cancer
Sponsor: AstraZeneca
ClinicalTrials ID:NCT01933932
This clinical trial is testing whether the combination of selumetinib and docetaxel is more effective than docetaxel alone in treating patients with advanced non-small cell lung cancer (NSCLC) that has a specific KRAS mutation and has not responded to initial treatment.
Patient Parameters
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Program Overview
The study aims to determine if selumetinib, when combined with the chemotherapy drug docetaxel, can better treat advanced non-small cell lung cancer (NSCLC) with a KRAS mutation compared to docetaxel alone. It will also evaluate the safety, how the body processes the drug, and the overall experience of patients receiving this combination treatment.
Description
This is a Phase III clinical trial that is double-blind, meaning neither the participants nor the researchers know who is receiving the actual treatment or a placebo. The study is randomized and placebo-controlled, focusing on patients who are receiving a second line of treatment for KRAS mutation-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC). The trial will compare the effects of selumetinib combined with docetaxel against a placebo combined with docetaxel. Researchers will assess the effectiveness, safety, and tolerability of the treatment, as well as how patients report their experiences.
Eligibility Criteria
Inclusion Criteria
- Must provide signed and dated consent before participating in the study.
- Must be 18 years or older.
- Must have a confirmed diagnosis of locally advanced or metastatic non-small cell lung cancer (NSCLC).
- Must have a tumor with a KRAS mutation, confirmed by a designated lab.
- Must have experienced disease progression after first-line anti-cancer therapy or a relapse after initial treatment.
Exclusion Criteria
- Cannot have a mix of small cell and non-small cell lung cancer.
- Cannot have received more than one prior anti-cancer drug regimen for advanced or metastatic NSCLC.
- Cannot have received any systemic anti-cancer therapy within 30 days before starting the study treatment.
- Cannot be receiving other anti-cancer therapies, except for steroids.
- Cannot have been treated with a MEK inhibitor or any docetaxel-containing regimen before (prior treatment with paclitaxel is allowed).
- Cannot have had radiation therapy within 4 weeks before starting the study treatment, or limited radiation for symptom relief within 7 days of the first dose.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 80045 | Aurora | Colorado |
| Research Site | 33028 | Pembroke Pines | Florida |
| Research Site | 30318 | Atlanta | Georgia |
| Research Site | 60637 | Chicago | Illinois |
| Research Site | 70006 | Metairie | Louisiana |
| Research Site | 02114 | Boston | Massachusetts |
| Research Site | 02215 | Boston | Massachusetts |
| Research Site | 01923 | Danvers | Massachusetts |
| Research Site | 10011 | New York | New York |
| Research Site | 10032 | New York | New York |
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