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
Launched by ASTRAZENECA · Aug 29, 2013
Trial Information
Current as of July 21, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at a new treatment approach for patients with advanced non-small cell lung cancer (NSCLC) that has a specific genetic change called a KRAS mutation. The trial is testing whether a combination of two drugs—selumetinib and docetaxel—works better than docetaxel alone in patients who have already tried one type of cancer treatment that didn't work. The main goals are to see how effective this combination is, how safe it is, and how patients feel while receiving the treatment.
To participate in this study, patients must be at least 18 years old and have a confirmed diagnosis of advanced NSCLC with a KRAS mutation. They should have experienced disease progression after their first treatment. However, patients with certain types of lung cancer or those who have received multiple previous treatments may not be eligible. During the trial, participants will receive regular check-ups to monitor their health and how they are responding to the treatment. It's important to note that this trial is currently active but not recruiting new participants.
Gender
ALL
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 30 days prior to starting study treatment
- • Other concomitant anti-cancer therapy agents excepts steroids
- • 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
About Astrazeneca
AstraZeneca is a global biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative medicines across various therapeutic areas, including oncology, cardiovascular, respiratory, and autoimmune diseases. With a strong commitment to scientific research and patient-centric solutions, AstraZeneca leverages cutting-edge technology and a robust pipeline to address unmet medical needs. The company collaborates with healthcare professionals, academic institutions, and other organizations to advance clinical trials and deliver transformative therapies, aiming to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
New York, New York, United States
Philadelphia, Pennsylvania, United States
Morgantown, West Virginia, United States
Durham, North Carolina, United States
Paris, , France
London, , United Kingdom
Manchester, , United Kingdom
Porto Alegre, , Brazil
Sao Paulo, , Brazil
Sofia, , Bulgaria
Varna, , Bulgaria
Moscow, , Russian Federation
Barcelona, , Spain
Madrid, , Spain
Nottingham, , United Kingdom
Milano, , Italy
Nashville, Tennessee, United States
Napoli, , Italy
Roma, , Italy
Monterrey, , Mexico
Málaga, , Spain
Ankara, , Turkey
Istanbul, , Turkey
Izmir, , Turkey
Saint Petersburg, , Russian Federation
Gent, , Belgium
Pembroke Pines, Florida, United States
Sofia, , Bulgaria
Varna, , Bulgaria
Kazan, , Russian Federation
Amsterdam, , Netherlands
Brussels, , Belgium
Gent, , Belgium
Barretos, , Brazil
Nyíregyháza, , Hungary
Dnipro, , Ukraine
Sumy, , Ukraine
Uzhhorod, , Ukraine
Bari, , Italy
Perugia, , Italy
Aurora, Colorado, United States
Lima, , Peru
Kazan, , Russian Federation
Pembroke Pines, Florida, United States
Maastricht, , Netherlands
São Paulo, , Brazil
Clermont Ferrand, , France
Chicago, Illinois, United States
Seattle, Washington, United States
Milano, , Italy
Zaragoza, , Spain
London, , United Kingdom
Manchester, , United Kingdom
Leuven, , Belgium
Roeselare, , Belgium
Edmonton, Alberta, Canada
Toronto, Ontario, Canada
Lille, , France
Tel Hashomer, , Israel
Napoli, , Italy
Warszawa, , Poland
Wolverhampton, , United Kingdom
Plovdiv, , Bulgaria
Vratza, , Bulgaria
Innsbruck, , Austria
Salzburg, , Austria
Wien, , Austria
Camperdown, , Australia
Toulouse, , France
Bari, , Italy
Málaga, , Spain
Haifa, , Israel
Madrid, , Spain
Oshawa, Ontario, Canada
Bydgoszcz, , Poland
Gdańsk, , Poland
Hershey, Pennsylvania, United States
Cordoba, , Argentina
Surrey, British Columbia, Canada
Halifax, Nova Scotia, Canada
Tel Aviv, , Israel
Gdańsk, , Poland
Saint Petersburg, , Russian Federation
Brest Cedex, , France
Bad Berka, , Germany
Orbassano, , Italy
Coimbra, , Portugal
Morgantown, West Virginia, United States
Boston, Massachusetts, United States
Sutton, , United Kingdom
Augsburg, , Germany
Halle, , Germany
Ulm, , Germany
Würzburg, , Germany
Köln, , Germany
Madrid, , Spain
Philadelphia, Pennsylvania, United States
Nottingham, , United Kingdom
Amsterdam, , Netherlands
Linz, , Austria
Dijon, , France
Großhansdorf, , Germany
Heidelberg, , Germany
Löwenstein, , Germany
Wiesbaden, , Germany
Törökbálint, , Hungary
Kyiv, , Ukraine
Volgograd, , Russian Federation
Barcelona, , Spain
Fitzroy, , Australia
Sevilla, , Spain
São Paulo, , Brazil
Grosshansdorf, , Germany
Moers, , Germany
München, , Germany
Olsztyn, , Poland
Szczecin, , Poland
Cluj Napoca, , Romania
Brest Cedex, , France
Clermont Ferrand, , France
Rennes Cedex 9, , France
Mexico, , Mexico
Bruxelles, , Belgium
Porto, , Portugal
Linköping, , Sweden
Budapest, , Hungary
Danvers, Massachusetts, United States
Kelowna, British Columbia, Canada
Petah Tikva, , Israel
Bergen Op Zoom, , Netherlands
Metairie, Louisiana, United States
Kaposvár, , Hungary
Toulouse Cedex 09, , France
Pierre Benite Cedex, , France
Lisboa, , Portugal
Volgograd, , Russian Federation
Izmir, , Turkey
Moscow, , Russian Federation
Parma, , Italy
Rosario, , Argentina
Kharkiv Region, , Ukraine
Monterrey, , Mexico
Miraflores, , Peru
Miskolc, , Hungary
Opole, , Poland
Darlinghurst, , Australia
Porto Alegre, , Brazil
São José Do Rio Preto, , Brazil
Quebec, , Canada
Caen, , France
Perugia, , Italy
Kraków, , Poland
örebro, , Sweden
Ijui, , Brazil
Edelény, , Hungary
Den Bosch, , Netherlands
Maastricht, , Netherlands
Grudziądz, , Poland
Istanbul, , Turkey
Amadora, , Portugal
Kogarah, , Australia
Chermside, , Australia
Ankara, , Turkey
Montreal, Quebec, Canada
Genova, , Italy
Roma, , Italy
Paris, , France
Atlanta, Georgia, United States
New York, New York, United States
Buenos Aires, , Argentina
Ciudad De Buenos Aires, , Argentina
Kurralta Park, , Australia
Malvern, , Australia
Woodville South, , Australia
Vienna, , Austria
Pelotas, , Brazil
Sao Paulo, , Brazil
Regina, Saskatchewan, Canada
Saskatoon, Saskatchewan, Canada
Santiago, , Chile
Marseille Cedex 20, , France
Dortmund, , Germany
Gerlingen, , Germany
Homburg, , Germany
Győr, , Hungary
Nyíregyháza, , Hungary
Beer Sheva, , Israel
Kfar Saba, , Israel
Livorno, , Italy
Brzozow, , Poland
Lubin, , Poland
Sucha Beskidzka, , Poland
Vila Nova De Gaia, , Portugal
Saint Petersburg, , Russian Federation
Saint Petersburg, , Russian Federation
Vigo(pontevedra), , Spain
Uppsala, , Sweden
İstanbul, , Turkey
Manisa, , Turkey
Chernivtsі, , Ukraine
Kryvyi Rih, , Ukraine
Zaporizhzhia, , Ukraine
Aberdeen, , United Kingdom
Wendouree, , Australia
Patients applied
Trial Officials
Gabriella Mariani, MD
Study Chair
AstraZeneca UK, MSD
Pasi Jänne, MD
Principal Investigator
Dana-Faber Cancer Institute, USA
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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