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

Status: Recruiting
Diagnosis: Lung Cancer
NCT ID: NCT01933932 (View complete trial on
DFCI Protocol ID: 14-057


The purpose of this study is to assess the efficacy of selumetinib in combination with docetaxel (75mg/m2) vs placebo in combination with docetaxel (75mg/m2) in patients with locally advance or metastatic NSCLCs that harbor mutations of KRAS. This study will also assess the PK, safety, patient reported outcomes (PRO) and tolerability profile of the selumetinib/docetaxel combination, compared to placebo in combination with docetaxel


Conducting Institutions:
Brigham and Women's Hospital, Dana-Farber Cancer Institute, Beth-Israel Deaconess Medical Center, Massachusetts General Hospital

Overall PI:
Pasi Janne, MD, PhD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Daniel Costa, MD, Beth Israel Deaconess Medical Center
Alice Shaw, MD, PhD, Massachusetts General Hospital

Dana-Farber Cancer Institute: Bryan Marion,
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: - Provision of signed, written and dated informed consent prior to any study specific procedures - Male or female, aged 18 years or older - Histological or cytological confirmation of locally advanced or metastatic NSCLC (IIIB-IV) - KRAS mutation positive tumour sample as determined by the designated testing laboratory - Failure of 1st line anti-cancer therapy due to radiological documentation of disease progression in advanced disease or subsequent relapse of disease following 1st line therapy Exclusion Criteria: - Mixed small cell and non-small cell lung cancer histology. - Received >1 prior anti-cancer drug regimen for advanced or metastatic NSCLC. Patients who develop disease progression while on switch maintenance therapy (maintenance using an agent not in the first-line regimen) will not be eligible. - Receiving or have received systemic anti-cancer therapy within 4 weeks prior to starting study treatment (6 weeks for nitrosoureas, mitomycin, and suramin) or any anti-cancer therapy which has not been cleared from the body by the time of starting study treatment. - Prior treatment with a Mitogen-Activated protein Kinase (MEK) inhibitor or any docetaxel-containing regimen (prior treatment with paclitaxel is acceptable). - Last radiation therapy within 4 weeks prior starting study treatment, or limited field of radiation for palliation within 7 days of the first dose of study treatment
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