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A phase 3 trial of Selumetinib, Docetaxel in non-small-cell lung cancer and small-cell lung cancer, run by AstraZeneca, active and no longer recruiting.
Assess Efficacy & Safety of Selumetinib in Combination With Docetaxel in Patients Receiving 2nd Line Treatment for v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Positive NSCLC is a phase 3 interventional study registered as NCT01933932 by AstraZeneca, with 510 participants enrolled, started 2013-09-25 and due to reach its primary completion in 2016-06-07. Interventions recorded: Selumetinib, Docetaxel, Placebo, Pegylated G-CSF. Conditions listed: Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV. Results were posted on ClinicalTrials.gov in 2017; the figures recorded here are the registry's, not a publication's.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
510 enrolled.
IQR 1.5 to 5.9; Figures from the ClinicalTrials.gov results section (first posted 2017-08-29), not from a publication · IQR 1.4 to 5.5
SourceIQR 3.6 to 16.8; Figures from the ClinicalTrials.gov results section (first posted 2017-08-29), not from a publication · IQR 3.8 to 20.1
SourceFigures from the ClinicalTrials.gov results section (first posted 2017-08-29), not from a publication
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-Free Survival (PFS)primary | Selumetinib + Docetaxel | 254 | 3.9 months | 0.93 (0.77 to 1.12) | 0.4355 | link |
| Placebo + Docetaxel | 256 | 2.8 months | ||||
| Overall Survival (OS) | Selumetinib + Docetaxel | 254 | 8.7 months | 1.05 (0.85 to 1.3) | 0.6431 | link |
| Placebo + Docetaxel | 256 | 7.9 months | ||||
| Objective Response Rate (ORR) | Selumetinib + Docetaxel | 254 | 51 participants | - | 0.0515 | link |
| Placebo + Docetaxel | 256 | 35 participants |
Shares Docetaxel, AstraZeneca, Small-cell lung cancer, Cytotoxic chemotherapy.
Shares Docetaxel, Small-cell lung cancer, Small-molecule kinase inhibitors, Cytotoxic chemotherapy.
Shares Docetaxel, Small-cell lung cancer, Cytotoxic chemotherapy, Non-small-cell lung cancer.
Shares Docetaxel, Small-cell lung cancer, Cytotoxic chemotherapy, Non-small-cell lung cancer.
Shares Docetaxel, AstraZeneca, Small-molecule kinase inhibitors, Cytotoxic chemotherapy.
Shares Docetaxel, Small-cell lung cancer, Cytotoxic chemotherapy, Non-small-cell lung cancer.
Shares Docetaxel, Small-cell lung cancer, Cytotoxic chemotherapy, Non-small-cell lung cancer.
Shares Docetaxel, Small-cell lung cancer, Cytotoxic chemotherapy, Non-small-cell lung cancer.