Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IVPhase 3SELECT-1NCT01933932

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

A Phase 3 study testing Selumetinib, Docetaxel and Pegylated G-CSF in people with Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV, run by AstraZeneca at 197 sites in 26 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 to 130 years
Conditions the study is for: Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV
What is being tested?: Selumetinib, Docetaxel and Pegylated G-CSF
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 510 participants
Where: 197 sitesin 26 countries
Study dates: 25 Sep 2013to 31 Dec 2026
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 130 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

197 sites in 26 countries.

Country

City, postcode or hospital

197 sites in 26 countries

United States17 sites

Research Site
Atlanta, Georgia, 30318
Research Site
Aurora, Colorado, 80045
Research Site
Boston, Massachusetts, 02114
Research Site
Boston, Massachusetts, 02215
Research Site
Chicago, Illinois, 60637
Research Site
Danvers, Massachusetts, 01923
Research Site
Durham, North Carolina, 27710
Research Site
Hershey, Pennsylvania, 17033
Research Site
Metairie, Louisiana, 70006
Research Site
Morgantown, West Virginia, 26506
Research Site
Nashville, Tennessee, 37203
Research Site
Nashville, Tennessee, 37232
Research Site
New York, New York, 10011
Research Site
New York, New York, 10032
Research Site
Pembroke Pines, Florida, 33028
Research Site
Philadelphia, Pennsylvania, 19107
Research Site
Seattle, Washington, 98104

Other trials in United States

Germany15 sites

Research Site
Augsburg, 86156
Research Site
Bad Berka, 99437
Research Site
Cologne, 50937
Research Site
Dortmund, 44309
Research Site
Gerlingen, 70839
Research Site
Großhansdorf, 22927
Research Site
Halle, 06120
Research Site
Heidelberg, 69126
Research Site
Homburg, 66424
Research Site
Löwenstein, 74245
Research Site
Moers, 47441
Research Site
München, 81925
Research Site
Ulm, 89081
Research Site
Wiesbaden, 65199
Research Site
Würzburg, 97080

Other trials in Germany

Poland12 sites

Research Site
Brzozów, 36-200
Research Site
Bydgoszcz, 85-796
Research Site
Gdansk, 80-219
Research Site
Gdansk, 80-952
Research Site
Grudziądz, 86-300
Research Site
Krakow, 31-202
Research Site
Lubin, 59-301
Research Site
Olsztyn, 10-357
Research Site
Opole, 45-061
Research Site
Sucha Beskidzka, 34-200
Research Site
Szczecin, 70-891
Research Site
Warsaw, 02-781

Other trials in Poland

Canada10 sites

Research Site
Edmonton, Alberta, T6G 1Z2
Research Site
Halifax, Nova Scotia, B3H 1V7
Research Site
Kelowna, British Columbia, V1Y 5L3
Research Site
Montreal, Quebec, H4A 3J1
Research Site
Oshawa, Ontario, L1G 2B9
Research Site
Québec, Quebec, G1V 4G5
Research Site
Regina, Saskatchewan, S4T 7T1
Research Site
Saskatoon, Saskatchewan, S7N 4H4
Research Site
Surrey, British Columbia, V3V 1Z2
Research Site
Toronto, Ontario, M5G 2M9

Other trials in Canada

France10 sites

Research Site
Brest, 29609
Research Site
Caen, F-14033
Research Site
Clermont-Ferrand, 63003
Research Site
Dijon, 21079
Research Site
Lille, 59000
Research Site
Marseille, 13915
Research Site
Paris, 75020
Research Site
Pierre-Bénite, 69310
Research Site
Rennes, 35033
Research Site
Toulouse, 31059

Other trials in France

Italy10 sites

Research Site
Bari, 70124
Research Site
Genova, 16100
Research Site
Livorno, 57100
Research Site
Milan, 20132
Research Site
Naples, 80131
Research Site
Orbassano, 10043
Research Site
Parma, 43126
Research Site
Perugia, 06132
Research Site
Roma, 00128
Research Site
Roma, 00144

Other trials in Italy

Australia9 sites

Research Site
Camperdown, 2050
Research Site
Chermside, 4032
Research Site
Darlinghurst, 2010
Research Site
Fitzroy, 3065
Research Site
Kogarah, 2217
Research Site
Kurralta Park, 5037
Research Site
Malvern, 3144
Research Site
Wendouree, 3355
Research Site
Woodville South, 5011

Other trials in Australia

Brazil9 sites

Research Site
Barretos, 14784-400
Research Site
Ijuí, 98700-000
Research Site
Pelotas, 096015-280
Research Site
Porto Alegre, 90035-003
Research Site
Porto Alegre, 90610-000
Research Site
São José do Rio Preto, 15090-000
Research Site
São Paulo, 01209-000
Research Site
São Paulo, 01246-000
Research Site
São Paulo

Other trials in Brazil

Hungary8 sites

Research Site
Budapest, 1121
Research Site
Budapest, 1122
Research Site
Edelény, 3780
Research Site
Győr, 9024
Research Site
Kaposvár, 7400
Research Site
Miskolc, 3529
Research Site
Nyíregyháza, 4400
Research Site
Törökbálint, 2045

Other trials in Hungary

Peru8 sites

Research Site
Lima, 15033
Research Site
Lima, 15073
Research Site
Lima, L27
Research Site
Lima, LIMA 01
Research Site
Lima, LIMA 11
Research Site
Lima, LIMA 29
Research Site
Lima, LIMA 34
Research Site
Miraflores, 15046

Other trials in Peru

Spain8 sites

Research Site
Barcelona, 08003
Research Site
Madrid, 08035
Research Site
Madrid, 28034
Research Site
Madrid, 28041
Research Site
Málaga, 29010
Research Site
Seville, 41013
Research Site
Vigo(Pontevedra), 36204
Research Site
Zaragoza, 50009

Other trials in Spain

Ukraine8 sites

Research Site
Chernivtsі, 58013
Research Site
Dnipro, 49102
Research Site
Kharkiv Region, 61070
Research Site
Kryvyi Rih, 50048
Research Site
Kyiv, 03115
Research Site
Sumy, 40022
Research Site
Uzhhorod, 88000
Research Site
Zaporizhzhya, 69040

Other trials in Ukraine

Portugal7 sites

Research Site
Amadora, 2720-276
Research Site
Coimbra, 3040-316
Research Site
Lisbon, 1099-023
Research Site
Lisbon, 1769-001
Research Site
Porto, 4100-180
Research Site
Porto, 4200-319
Research Site
Vila Nova de Gaia, 4434-502

Other trials in Portugal

Russia7 sites

Research Site
Kazan', 420012
Research Site
Moscow, 105229
Research Site
Moscow, 115478
Research Site
Saint Petersburg, 194291
Research Site
Saint Petersburg, 197342
Research Site
Saint Petersburg, 197758
Research Site
Volgograd, 400138

Other trials in Russia

Turkey (Türkiye)7 sites

Research Site
Ankara, 06230
Research Site
Ankara, 06280
Research Site
Istanbul, 34662
Research Site
Istanbul, 34844
Research Site
Izmir, 35100
Research Site
Izmir, 35110
Research Site
Manisa, 45030

Other trials in Turkey (Türkiye)

Belgium6 sites

Research Site
Brussels, 1000
Research Site
Brussels, 1090
Research Site
Brussels, 1200
Research Site
Ghent, 9000
Research Site
Leuven, 3000
Research Site
Roeselare, 8800

Other trials in Belgium

Bulgaria6 sites

Research Site
Plovdiv, 4000
Research Site
Sofia, 1233
Research Site
Sofia, 1303
Research Site
Sofia, 1330
Research Site
Varna, 9010
Research Site
Vratsa, 3000

Other trials in Bulgaria

Chile6 sites

Research Site
Santiago, 7500921
Research Site
Santiago, 7520349
Research Site
Santiago, 7630370
Research Site
Santiago, 8360160
Research Site
Santiago, 8380456
Research Site
Santiago, 8420383

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Israel6 sites

Research Site
Beersheba, 8410101
Research Site
Haifa, 31096
Research Site
Kfar Saba, 4428164
Research Site
Petah Tikva, 49100
Research Site
Tel Aviv, 64239
Research Site
Tel HaShomer, 52621

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United Kingdom6 sites

Research Site
Aberdeen, AB2 2ZB
Research Site
London, SW3 6JJ
Research Site
Manchester, M20 4BX
Research Site
Nottingham, NG5 1PB
Research Site
Sutton, SM2 5PT
Research Site
Wolverhampton, WV10 0QP

Other trials in United Kingdom

Argentina5 sites

Research Site
Buenos Aires, 1426
Research Site
Ciudad de Buenos Aires, 1180
Research Site
Ciudad de Buenos Aires, C1025ABI
Research Site
Córdoba, 5000
Research Site
Rosario, S2000KZE

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Austria5 sites

Research Site
Innsbruck, 6020
Research Site
Linz, 4020
Research Site
Salzburg, 5020
Research Site
Vienna, 1100
Research Site
Vienna, 1160

Other trials in Austria

Netherlands5 sites

Research Site
's-Hertogenbosch, 5223 GZ
Research Site
Amsterdam, 1066 CX
Research Site
Amsterdam, 1081 HV
Research Site
Bergen op Zoom, 4624 VT
Research Site
Maastricht, 6202 AZ

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Sweden3 sites

Research Site
Linköping, 581 85
Research Site
Örebro, 701 85
Research Site
Uppsala, SE-751 85

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Mexico2 sites

Research Site
México, 14080
Research Site
Monterrey, 64460

Other trials in Mexico

Romania2 sites

Research Site
Cluj-Napoca, 400015
Research Site
Cluj-Napoca, 400058

Other trials in Romania

About this study

Official title: 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)

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

Read the detailed description

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)

Conditions: Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV
Being tested: Selumetinib, Docetaxel, Placebo, Pegylated G-CSF
Keywords: Mitogen-Activated Protein Kinase Kinase inhibitor; Non Small Cell Lung Cancer; metastatic; second line treatment for Non Small Cell Lung Cancer; KRAS mutation
Medical subject headings: Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SelumetinibDrug
Also called AZD6244; ARRY-142886
Three 25 mg selumetinib capsules (Hyd-Sulfate) be administered orally, twice daily, (total dose 75 mg dose bd) on an uninterrupted schedule.
DocetaxelDrug
Docetaxel 75 mg/m2 will be administered intravenously on day 1 of each 21 day cycle.
PlaceboDrug
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.
Pegylated G-CSFDrug
Also called Pegfilgrastim 6 mg
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.

Study groups in NCT01933932
Study group	Role	What they receive
Selumetinib + Docetaxel	Experimental	Three 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 Receives: Drug: Selumetinib; Drug: Docetaxel; Drug: Pegylated G-CSF
Placebo + Docetaxel	Experimental	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. Receives: Drug: Docetaxel; Drug: Placebo; Drug: Pegylated G-CSF

What is being measured

The primary outcome is the main question the study is designed to answer.

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: 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)
Overall Survival is defined as the time from the date of randomisation until death due to any cause.
Measured: Measured at baseline until date of death due to any cause. Estimated final completion : approximately 3.5 years after FSI
Objective Response Rate (ORR)
ORR is defined as the number (%) of subjects with at least one overall visit response of complete response (CR) or partial response (PR). Per RECIST v1.1 for target lesions and assessed by CT/MRI: CR - disappearance of all target lesions; PR - >=30% decrease in the sum of the longest diameter of target lesion. (Non-target lesion and new lesion results are also taken into account for the overall visit result)
Measured: 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)
Duration of response is defined as the time from the date of first documented response until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression)
Measured: 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)
The symptom improvement rate will be defined as the number (%) of patients with two consecutive assessments at least 18 days apart (ie 21 days allowing a visit window of 3 days) which showed a clinically meaningful improvement in symptoms from baseline (defined as a decrease in the ASBI from baseline ≥10). LCSS-Lung Cancer Symptom Scale; ASBI-Average symptom burden index.
Measured: 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)
Time to symptom progression will be defined as the time from randomization until the date of first clinically meaningful symptom deterioration (defined as an increase in the ASBI from baseline ≥10), or death (by any cause). LCSS-Lung Cancer Symptom Scale; ASBI-Average symptom burden index.
Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Sep 201331 Dec 2026

First posted2 Sep 2013 (estimated)
Study start25 Sep 2013
Primary completion7 Jun 2016
Study completion31 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IVStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 510 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01933932
Sponsor's protocol ID: D1532C00079
Other IDs: 2013-001676-38
Acronym: SELECT-1
Status last verified: Jun 2026
First submitted: 29 Aug 2013
Last updated: 21 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: 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

Publications

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.
PubMed 28492898
Janne 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.
PubMed 26837474

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT01933932
Acronym / sponsor ID: SELECT-1 / D1532C00079
Conditions: Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV
Keywords: Mitogen-Activated Protein Kinase Kinase inhibitor; Non Small Cell Lung Cancer; metastatic; second line treatment for Non Small Cell Lung Cancer; KRAS mutation
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 510 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 25 Sep 2013 (actual)
Primary completion: 7 Jun 2016 (actual)
Study completion: 31 Dec 2026 (estimated)
First posted: 2 Sep 2013 (estimated)
Results: Posted 29 Aug 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Selumetinib + Docetaxel	Experimental	Drug: Selumetinib, Drug: Docetaxel, Drug: Pegylated G-CSFThree 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	Experimental	Drug: Docetaxel, Drug: Placebo, Drug: Pegylated G-CSFThree 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.

Who may qualify

Ages: 18 to 130 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (6 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SelumetinibAlso: AZD6244; ARRY-142886Three 25 mg selumetinib capsules (Hyd-Sulfate) be administered orally, twice daily, (total dose 75 mg dose bd) on an uninterrupted schedule.	Drug	Selumetinib + Docetaxel
DocetaxelDocetaxel 75 mg/m2 will be administered intravenously on day 1 of each 21 day cycle.	Drug	Placebo + Docetaxel, Selumetinib + Docetaxel
PlaceboThree 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.	Drug	Placebo + Docetaxel
Pegylated G-CSFAlso: Pegfilgrastim 6 mgAll 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.	Drug	Placebo + Docetaxel, Selumetinib + Docetaxel

Primary outcome

Progression-Free Survival (PFS)
Time frame: Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)
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)

5 secondary outcomes

Overall Survival (OS)
Time frame: Measured at baseline until date of death due to any cause. Estimated final completion : approximately 3.5 years after FSI
Objective Response Rate (ORR)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)

Results and safety

Results posted to the registry on 29 Aug 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Selumetinib + Docetaxel	254	70
Placebo + Docetaxel	256	78

Primary outcome: Progression-Free Survival (PFS)

Time frame: Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI). Median (Inter-Quartile Range). Unit: Months

Measure	Selumetinib + Docetaxel n = 254	Placebo + Docetaxel n = 256
Value	3.9 (1.5 to 5.9)	2.8 (1.4 to 5.5)

Selumetinib + Docetaxel vs Placebo + Docetaxel: Hazard Ratio (HR): 0.93 (95% CI 0.77 to 1.12), p = 0.4355, Log Rank

Population analysed: Full analysis set (FAS) population comprised of all randomised patients.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo + Docetaxel	82 of 254 (32.3%)	235 of 254 (92.5%)	Not reported
Selumetinib + Docetaxel	124 of 251 (49.4%)	244 of 251 (97.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28492898Janne 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.
Derived from this study: PubMed 26837474Janne 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.
CSP\_redactedLink provided by the sponsor.
Individual participant dataSharing planned: Yes. 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

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gabriella Mariani, MD study chair

AstraZeneca UK, MSD

Pasi Jänne, MD principal investigator

Dana-Faber Cancer Institute, USA

197 sites in 26 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 197 sites in United States, Germany, Poland, Canada, France and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (time frame: Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01933932, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.