Adults 18 to 130, any sex, with Non Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall SurvivalPrimary· At least 12 months since start of treatment.
OS was calculated as the interval from the date of randomisation to the date of patient death (any cause). Patients who had not died at the time of the final analysis, or who withdrew consent, were censored at the last date the patient was known to be alive.
Group
Value
95% CI
AZD6244 + Docetaxel
29
Placebo + Docetaxel
27
AZD6244 + Docetaxel
13
Placebo + Docetaxel
13
AZD6244 + Docetaxel
1
Placebo + Docetaxel
0
Progression Free SurvivalSecondary· At least 12 months after start of treatment
PFS was defined as the interval between the date of randomisation and the earlier date of objective disease progression per RECIST criteria or death due to any cause in the absence of progression. Patients who did not progress or die at the time of analysis were censored at the time of their latest evaluable objective tumour assessment. This also included patients who withdrew consent.
Group
Value
95% CI
AZD6244 + Docetaxel
35
Placebo + Docetaxel
36
AZD6244 + Docetaxel
1
Placebo + Docetaxel
2
AZD6244 + Docetaxel
7
Placebo + Docetaxel
2
Objective Response RateSecondary· At least 12 months after start of treatment
ORR is defined as the ratio of proportions, patients with at least one visit response of CR or PR in AZD6244 + Docetaxel vs Placebo + Docetaxel.
Group
Value
95% CI
AZD6244 + Docetaxel
16
Placebo + Docetaxel
0
AZD6244 + Docetaxel
27
Placebo + Docetaxel
40
Duration of ResponseSecondary· At least 12 months after start of treatment
Duration of response is defined as the time from the date of first documented response until date of documented progression or death in the absence of disease progression, the end of response should coincide with the date of progression or death from any cause used for the PFS endpoint.
Group
Value
95% CI
AZD6244 + Docetaxel
193.4
± 0.207
Placebo + Docetaxel
NA
± NA
Change From Baseline in Tumour Size at 6 Week.Secondary· 6 weeks after first dose of treatment
Percentage change from baseline in tumour size at 6 week. Values calculated as tumour sizes at 6 weeks minus value at baseline.
Group
Value
95% CI
AZD6244 + Docetaxel
-16.98
-27.1 – -6.85
Placebo + Docetaxel
0.05
-9.84 – 9.93
Change From Baseline in Tumour Size at Week 12Secondary· 12 weeks
Percentage change from baseline in tumour size at Week 12. Values calculated as tumour sizes at 12 weeks minus value at baseline.
Group
Value
95% CI
AZD6244 + Docetaxel
-19.38
-34.7 – -4.09
Placebo + Docetaxel
6.62
-8.31 – 21.54
Alive and Progression-Free at 6 MonthsSecondary· 6 months after first dose of treatment
Percentage of patients alive and progression-free at 6 months
Group
Value
95% CI
AZD6244 + Docetaxel
37.1
Placebo + Docetaxel
15.8
Adverse events — posted to ClinicalTrials.gov
Time frame: Over a minimum period of 12 months since start of treatment, or the date of the final analysis of the data, whichever is the later.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT01362803 — AZD6244 Hydrogen Sulfate for Children With Nervous System Tumors
· Phase 1, PHASE2
· active not recruiting
NCT01248247 — BATTLE-2 Program: A Biomarker-Integrated Targeted Therapy Study in Previously Treated Patients With Advanced Non-Small C
· Phase 2
· completed
NCT01306045 — Molecular Profiling and Targeted Therapy for Advanced Non-Small Cell Lung Cancer, Small Cell Lung Cancer, and Thymic Mal
· Phase 2
· completed
NCT01287130 — AZD6244 With Cetuximab for Solid Tumors and Colorectal Cancer
· Phase 1
· completed
NCT01229150 — Randomized Phase II Study of AZD6244 (Mitogen-activated Protein Kinase Inhibitor) MEK-Inhibitor With Erlotinib in KRAS W
· Phase 2
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
Last refreshed: 20 June 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00890825.