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
SELECT-1
A Phase III, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy and Safety of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Combination With Docetaxel, in Patients Receiving Second Line Treatment for KRAS Mutation-Positive Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB - IV) (SELECT 1)
2 other identifiers
interventional
510
25 countries
188
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2013
Longer than P75 for phase_3
188 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 29, 2013
CompletedFirst Posted
Study publicly available on registry
September 2, 2013
CompletedStudy Start
First participant enrolled
September 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 7, 2016
CompletedResults Posted
Study results publicly available
August 29, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedNovember 19, 2025
November 1, 2025
2.7 years
August 29, 2013
February 27, 2017
November 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS)
Progression free survival is defined as the time from randomisation until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression)
Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)
Secondary Outcomes (5)
Overall Survival (OS)
Measured at baseline until date of death due to any cause. Estimated final completion : approximately 3.5 years after FSI
Objective Response Rate (ORR)
Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)
Duration of Response (DoR)
Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)
Symptom Improvement Rate Using Average Symptom Burden Index (ASBI) of the Lung Cancer Symptom Scale (LCSS)
Measured from date of randomisation until 30 days post treatment discontinuation or 30 days post progression (if study treatment is discontinued before progression). Estimated final completion : approximately 3 years after first subject in (FSI)
Time to Symptom Progression Using Average Symptom Burden Index (ASBI) of the Lung Cancer Symptom Scale (LCSS)
Measured from date of randomisation until 30 days post treatment discontinuation or 30 days post progression (if study treatment is discontinued before progression). Estimated final completion : approximately 3 years after first subject in (FSI)
Study Arms (2)
Selumetinib + Docetaxel
EXPERIMENTALThree 25mg Selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle
Placebo + Docetaxel
EXPERIMENTALThree placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.
Interventions
Three 25 mg selumetinib capsules (Hyd-Sulfate) be administered orally, twice daily, (total dose 75 mg dose bd) on an uninterrupted schedule.
Docetaxel 75 mg/m2 will be administered intravenously on day 1 of each 21 day cycle.
Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.
All patients will receive pegylated Granulocyte Colony Stimulating Factor (G-CSF) at least 24 hours after administration of every docetaxel dose and not within 14 days prior to the next docetaxel administration.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (197)
Research Site
Aurora, Colorado, 80045, United States
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Pembroke Pines, Florida, 33028, United States
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Atlanta, Georgia, 30318, United States
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Chicago, Illinois, 60637, United States
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Metairie, Louisiana, 70006, United States
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Boston, Massachusetts, 02114, United States
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Boston, Massachusetts, 02215, United States
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Danvers, Massachusetts, 01923, United States
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New York, New York, 10011, United States
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New York, New York, 10032, United States
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Durham, North Carolina, 27710, United States
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Hershey, Pennsylvania, 17033, United States
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Philadelphia, Pennsylvania, 19107, United States
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Nashville, Tennessee, 37203, United States
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Nashville, Tennessee, 37232, United States
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Seattle, Washington, 98104, United States
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Morgantown, West Virginia, 26506, United States
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Buenos Aires, 1426, Argentina
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Ciudad de Buenos Aires, 1180, Argentina
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Ciudad de Buenos Aires, C1025ABI, Argentina
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Córdoba, 5000, Argentina
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Rosario, S2000KZE, Argentina
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Camperdown, 2050, Australia
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Chermside, 4032, Australia
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Darlinghurst, 2010, Australia
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Fitzroy, 3065, Australia
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Kogarah, 2217, Australia
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Kurralta Park, 5037, Australia
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Malvern, 3144, Australia
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Wendouree, 3355, Australia
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Woodville South, 5011, Australia
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Innsbruck, 6020, Austria
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Linz, 4020, Austria
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Salzburg, 5020, Austria
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Vienna, 1100, Austria
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Vienna, 1160, Austria
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Brussels, 1000, Belgium
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Brussels, 1090, Belgium
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Brussels, 1200, Belgium
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Ghent, 9000, Belgium
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Leuven, 3000, Belgium
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Roeselare, 8800, Belgium
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Barretos, 14784-400, Brazil
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Ijuí, 98700-000, Brazil
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Pelotas, 096015-280, Brazil
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Porto Alegre, 90035-003, Brazil
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Porto Alegre, 90610-000, Brazil
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São José do Rio Preto, 15090-000, Brazil
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São Paulo, 01209-000, Brazil
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São Paulo, 01246-000, Brazil
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São Paulo, Brazil
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Plovdiv, 4000, Bulgaria
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Sofia, 1233, Bulgaria
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Sofia, 1303, Bulgaria
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Sofia, 1330, Bulgaria
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Varna, 9010, Bulgaria
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Vratsa, 3000, Bulgaria
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Edmonton, Alberta, T6G 1Z2, Canada
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Kelowna, British Columbia, V1Y 5L3, Canada
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Surrey, British Columbia, V3V 1Z2, Canada
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Halifax, Nova Scotia, B3H 1V7, Canada
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Oshawa, Ontario, L1G 2B9, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Montreal, Quebec, H4A 3J1, Canada
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Québec, Quebec, G1V 4G5, Canada
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Regina, Saskatchewan, S4T 7T1, Canada
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Saskatoon, Saskatchewan, S7N 4H4, Canada
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Santiago, 7500921, Chile
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Santiago, 7520349, Chile
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Santiago, 7630370, Chile
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Santiago, 8360160, Chile
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Santiago, 8380456, Chile
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Santiago, 8420383, Chile
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Brest, 29609, France
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Caen, F-14033, France
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Clermont-Ferrand, 63003, France
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Dijon, 21079, France
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Lille, 59000, France
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Marseille, 13915, France
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Paris, 75020, France
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Pierre-Bénite, 69310, France
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Rennes, 35033, France
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Toulouse, 31059, France
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Augsburg, 86156, Germany
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Bad Berka, 99437, Germany
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Cologne, 50937, Germany
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Dortmund, 44309, Germany
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Gerlingen, 70839, Germany
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Großhansdorf, 22927, Germany
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Halle, 06120, Germany
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Heidelberg, 69126, Germany
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Homburg, 66424, Germany
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Löwenstein, 74245, Germany
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Moers, 47441, Germany
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München, 81925, Germany
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Ulm, 89081, Germany
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Wiesbaden, 65199, Germany
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Würzburg, 97080, Germany
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Budapest, 1121, Hungary
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Budapest, 1122, Hungary
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Edelény, 3780, Hungary
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Győr, 9024, Hungary
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Kaposvár, 7400, Hungary
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Miskolc, 3529, Hungary
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Nyíregyháza, 4400, Hungary
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Törökbálint, 2045, Hungary
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Beersheba, 8410101, Israel
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Haifa, 31096, Israel
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Kfar Saba, 4428164, Israel
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Petah Tikva, 49100, Israel
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Tel Aviv, 64239, Israel
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Tel Litwinsky, 52621, Israel
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Bari, 70124, Italy
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Genova, 16100, Italy
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Livorno, 57100, Italy
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Milan, 20132, Italy
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Napoli, 80131, Italy
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Orbassano, 10043, Italy
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Parma, 43126, Italy
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Perugia, 06132, Italy
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Roma, 00128, Italy
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Roma, 00144, Italy
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México, 14080, Mexico
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Monterrey, 64460, Mexico
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's-Hertogenbosch, 5223 GZ, Netherlands
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Amsterdam, 1066 CX, Netherlands
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Amsterdam, 1081 HV, Netherlands
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Bergen op Zoom, 4624 VT, Netherlands
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Maastricht, 6202 AZ, Netherlands
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Lima, 15033, Peru
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Lima, 15073, Peru
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Lima, L27, Peru
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Lima, LIMA 01, Peru
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Lima, LIMA 11, Peru
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Lima, LIMA 29, Peru
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Lima, LIMA 34, Peru
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Miraflores, 15046, Peru
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Brzozów, 36-200, Poland
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Bydgoszcz, 85-796, Poland
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Gdansk, 80-219, Poland
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Gdansk, 80-952, Poland
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Grudziądz, 86-300, Poland
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Krakow, 31-202, Poland
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Lubin, 59-301, Poland
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Olsztyn, 10-357, Poland
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Opole, 45-061, Poland
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Sucha Beskidzka, 34-200, Poland
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Szczecin, 70-891, Poland
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Warsaw, 02-781, Poland
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Amadora, 2720-276, Portugal
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Coimbra, 3040-316, Portugal
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Lisbon, 1099-023, Portugal
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Lisbon, 1769-001, Portugal
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Porto, 4100-180, Portugal
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Porto, 4200-319, Portugal
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Vila Nova de Gaia, 4434-502, Portugal
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Cluj-Napoca, 400015, Romania
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Cluj-Napoca, 400058, Romania
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Kazan', 420012, Russia
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Moscow, 105229, Russia
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Moscow, 115478, Russia
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Saint Petersburg, 194291, Russia
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Saint Petersburg, 197342, Russia
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Saint Petersburg, 197758, Russia
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Volgograd, 400138, Russia
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Barcelona, 08003, Spain
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Madrid, 08035, Spain
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Madrid, 28034, Spain
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Madrid, 28041, Spain
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Málaga, 29010, Spain
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Seville, 41013, Spain
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Vigo(Pontevedra), 36204, Spain
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Zaragoza, 50009, Spain
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Linköping, 581 85, Sweden
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Örebro, 701 85, Sweden
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Uppsala, SE-751 85, Sweden
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Ankara, 06230, Turkey (Türkiye)
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Ankara, 06280, Turkey (Türkiye)
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Istanbul, 34662, Turkey (Türkiye)
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Istanbul, 34844, Turkey (Türkiye)
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Izmir, 35100, Turkey (Türkiye)
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Izmir, 35110, Turkey (Türkiye)
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Manisa, 45030, Turkey (Türkiye)
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Chernivtsі, 58013, Ukraine
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Dnipro, 49102, Ukraine
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Kharkiv Region, 61070, Ukraine
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Kryvyi Rih, 50048, Ukraine
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Kyiv, 03115, Ukraine
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Sumy, 40022, Ukraine
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Uzhhorod, 88000, Ukraine
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Zaporizhzhia, 69040, Ukraine
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Aberdeen, AB2 2ZB, United Kingdom
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London, SW3 6JJ, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Nottingham, NG5 1PB, United Kingdom
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Sutton, SM2 5PT, United Kingdom
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Wolverhampton, WV10 0QP, United Kingdom
Related Publications (2)
Janne PA, van den Heuvel MM, Barlesi F, Cobo M, Mazieres J, Crino L, Orlov S, Blackhall F, Wolf J, Garrido P, Poltoratskiy A, Mariani G, Ghiorghiu D, Kilgour E, Smith P, Kohlmann A, Carlile DJ, Lawrence D, Bowen K, Vansteenkiste J. Selumetinib Plus Docetaxel Compared With Docetaxel Alone and Progression-Free Survival in Patients With KRAS-Mutant Advanced Non-Small Cell Lung Cancer: The SELECT-1 Randomized Clinical Trial. JAMA. 2017 May 9;317(18):1844-1853. doi: 10.1001/jama.2017.3438.
PMID: 28492898DERIVEDJanne PA, Mann H, Ghiorghiu D. Study Design and Rationale for a Randomized, Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Selumetinib in Combination With Docetaxel as Second-Line Treatment in Patients With KRAS-Mutant Advanced Non-Small Cell Lung Cancer (SELECT-1). Clin Lung Cancer. 2016 Mar;17(2):e1-4. doi: 10.1016/j.cllc.2015.12.010. Epub 2015 Dec 30.
PMID: 26837474DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Gabriella Mariani
- Organization
- AstraZeneca Research and Development
Study Officials
- STUDY CHAIR
Gabriella Mariani, MD
AstraZeneca UK, MSD
- PRINCIPAL INVESTIGATOR
Pasi Jänne, MD
Dana-Faber Cancer Institute, USA
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2013
First Posted
September 2, 2013
Study Start
September 25, 2013
Primary Completion
June 7, 2016
Study Completion
December 31, 2025
Last Updated
November 19, 2025
Results First Posted
August 29, 2017
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure