For Healthcare Professionals

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

clipboard-pencil

About the study

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
user-3

Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


  1. Provision of signed, written and dated informed consent prior to any study specific procedures
  2. Male or female, aged 18 years or older
  3. Histological or cytological confirmation of locally advanced or metastatic NSCLC (IIIB-IV)
  4. KRAS mutation positive tumour sample as determined by the designated testing laboratory
  5. 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

Exclusion Criteria:


  1. Mixed small cell and non-small cell lung cancer histology.
  2. 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.
  3. Receiving or have received systemic anti-cancer therapy within 30 days prior to starting study treatment
  4. Other concomitant anti-cancer therapy agents excepts steroids
  5. Prior treatment with a Mitogen-Activated protein Kinase (MEK) inhibitor or any docetaxel-containing regimen (prior treatment with paclitaxel is acceptable).
  6. 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

pin location

Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV

Age (in years)

18 - 130

Phase

Phase 3

Participants needed

510

Est. Completion Date

Dec 29, 2023

Treatment type

Interventional


Sponsor

AstraZeneca

ClinicalTrials.gov identifier

NCT01933932

Study number

D1532C00079

Understanding Clinical Trials


Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?
Vector

Interested?

Sign up to save your favorites, 
receive newsletters, resources, and alerts 
about clinical trials related to your conditions of interest.