Phase 2
N=87
AZD6244 in Combination With Docetaxel Versus Docetaxel Alone in KRAS Mutation Positive NSCLC Patients
Non Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00890825 ↗Enrolled (actual)
87
Serious AEs
45.4%
Results posted
Jun 2018
Primary outcome: Primary: Overall Survival — 29; 27; 13; 13 Participants — p=0.2069
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AZD6244 (Drug); docetaxel (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
29; 27; 13; 13; 1; 0 | 0.2069 |
| SECONDARY Progression Free Survival |
35; 36; 1; 2; 7; 2 | 0.0138 sig |
| SECONDARY Objective Response Rate |
16; 0; 27; 40 | < 0.0001 sig |
| SECONDARY Duration of Response |
193.4; NA | — |
| SECONDARY Change From Baseline in Tumour Size at 6 Week. |
-16.98; 0.05 | 0.004 sig |
| SECONDARY Change From Baseline in Tumour Size at Week 12 |
-19.38; 6.62 | 0.004 sig |
| SECONDARY Alive and Progression-Free at 6 Months |
37.1; 15.8 | 0.0158 sig |
Summary
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.
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).
Exclusion Criteria
- Received >1 prior anti-cancer therapy for advanced or metastatic non small cell lung cancer (excluding radiotherapy)
- Prior treatment with a MEK inhibitor or any docetaxel containing regimen (prior treatment with paclitaxel is acceptable)
- Having received an investigational drug within 30 days of starting treatment, or have not recovered from side effects of an investigational drug
- Brain metastases or spinal cord compression unless asymptomatic, treated and stable off steroids and anti-convulsants for at least 1 month
Data sourced from ClinicalTrials.gov (NCT00890825). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.