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New drug cocktail aims to tackle KRAS lung cancer

NCT ID NCT01933932

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 22, 2026 · Updated 2 times

Summary

This phase 3 trial tests whether adding selumetinib (a targeted therapy) to standard chemotherapy (docetaxel) helps people with advanced KRAS-mutant lung cancer live longer without their cancer growing. About 510 adults whose cancer worsened after first treatment will receive either the combo or a placebo plus chemo. The study measures progression-free survival, overall survival, and side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Selumetinib (a targeted cancer drug) combined with docetaxel (chemotherapy)
What this could lead to
If successful, this combination could offer a new treatment option for people with a specific type of advanced lung cancer (KRAS mutation) that has stopped responding to initial therapy.
What could go wrong
This is a late-stage trial, but the drug combination may not improve survival or could cause significant side effects like infections or fatigue. Results may not apply to all lung cancer patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

510 people

The number who actually took part.

Started

Sep 2013

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 130 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Neoplasm Metastasis non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Locally advanced or metastatic non small cell lung cancer stage IIIB - iv

Contacts and locations

Locations

  • Research Site

    Aurora, Colorado, 80045, United States

  • Research Site

    Pembroke Pines, Florida, 33028, United States

  • Research Site

    Atlanta, Georgia, 30318, United States

  • Research Site

    Chicago, Illinois, 60637, United States

  • Research Site

    Metairie, Louisiana, 70006, United States

  • Research Site

    Boston, Massachusetts, 02114, United States

  • Research Site

    Boston, Massachusetts, 02215, United States

  • Research Site

    Danvers, Massachusetts, 01923, United States

  • Research Site

    New York, New York, 10011, United States

  • Research Site

    New York, New York, 10032, United States

  • Research Site

    Durham, North Carolina, 27710, United States

  • Research Site

    Hershey, Pennsylvania, 17033, United States

  • Research Site

    Philadelphia, Pennsylvania, 19107, United States

  • Research Site

    Nashville, Tennessee, 37203, United States

  • Research Site

    Nashville, Tennessee, 37232, United States

  • Research Site

    Seattle, Washington, 98104, United States

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    Morgantown, West Virginia, 26506, United States

  • Research Site

    Buenos Aires, 1426, Argentina

  • Research Site

    Ciudad de Buenos Aires, 1180, Argentina

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    Ciudad de Buenos Aires, C1025ABI, Argentina

  • Research Site

    Córdoba, 5000, Argentina

  • Research Site

    Rosario, S2000KZE, Argentina

  • Research Site

    Camperdown, 2050, Australia

  • Research Site

    Chermside, 4032, Australia

  • Research Site

    Darlinghurst, 2010, Australia

  • Research Site

    Fitzroy, 3065, Australia

  • Research Site

    Kogarah, 2217, Australia

  • Research Site

    Kurralta Park, 5037, Australia

  • Research Site

    Malvern, 3144, Australia

  • Research Site

    Wendouree, 3355, Australia

  • Research Site

    Woodville South, 5011, Australia

  • Research Site

    Innsbruck, 6020, Austria

  • Research Site

    Linz, 4020, Austria

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    Salzburg, 5020, Austria

  • Research Site

    Vienna, 1100, Austria

  • Research Site

    Vienna, 1160, Austria

  • Research Site

    Brussels, 1000, Belgium

  • Research Site

    Brussels, 1090, Belgium

  • Research Site

    Brussels, 1200, Belgium

  • Research Site

    Ghent, 9000, Belgium

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    Leuven, 3000, Belgium

  • Research Site

    Roeselare, 8800, Belgium

  • Research Site

    Barretos, 14784-400, Brazil

  • Research Site

    Ijuí, 98700-000, Brazil

  • Research Site

    Pelotas, 096015-280, Brazil

  • Research Site

    Porto Alegre, 90035-003, Brazil

  • Research Site

    Porto Alegre, 90610-000, Brazil

  • Research Site

    São José do Rio Preto, 15090-000, Brazil

  • Research Site

    São Paulo, 01209-000, Brazil

  • Research Site

    São Paulo, 01246-000, Brazil

  • Research Site

    São Paulo, Brazil

  • Research Site

    Plovdiv, 4000, Bulgaria

  • Research Site

    Sofia, 1233, Bulgaria

  • Research Site

    Sofia, 1303, Bulgaria

  • Research Site

    Sofia, 1330, Bulgaria

  • Research Site

    Varna, 9010, Bulgaria

  • Research Site

    Vratsa, 3000, Bulgaria

  • Research Site

    Edmonton, Alberta, T6G 1Z2, Canada

  • Research Site

    Kelowna, British Columbia, V1Y 5L3, Canada

  • Research Site

    Surrey, British Columbia, V3V 1Z2, Canada

  • Research Site

    Halifax, Nova Scotia, B3H 1V7, Canada

  • Research Site

    Oshawa, Ontario, L1G 2B9, Canada

  • Research Site

    Toronto, Ontario, M5G 2M9, Canada

  • Research Site

    Montreal, Quebec, H4A 3J1, Canada

  • Research Site

    Québec, Quebec, G1V 4G5, Canada

  • Research Site

    Regina, Saskatchewan, S4T 7T1, Canada

  • Research Site

    Saskatoon, Saskatchewan, S7N 4H4, Canada

  • Research Site

    Santiago, 7500921, Chile

  • Research Site

    Santiago, 7520349, Chile

  • Research Site

    Santiago, 7630370, Chile

  • Research Site

    Santiago, 8360160, Chile

  • Research Site

    Santiago, 8380456, Chile

  • Research Site

    Santiago, 8420383, Chile

  • Research Site

    Brest, 29609, France

  • Research Site

    Caen, F-14033, France

  • Research Site

    Clermont-Ferrand, 63003, France

  • Research Site

    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

  • Research Site

    Rennes, 35033, France

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    Toulouse, 31059, France

  • Research Site

    Augsburg, 86156, Germany

  • Research Site

    Bad Berka, 99437, Germany

  • Research Site

    Cologne, 50937, Germany

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    Dortmund, 44309, Germany

  • Research Site

    Gerlingen, 70839, Germany

  • Research Site

    Großhansdorf, 22927, Germany

  • Research Site

    Halle, 06120, Germany

  • Research Site

    Heidelberg, 69126, Germany

  • Research Site

    Homburg, 66424, Germany

  • Research Site

    Löwenstein, 74245, Germany

  • Research Site

    Moers, 47441, Germany

  • Research Site

    München, 81925, Germany

  • Research Site

    Ulm, 89081, Germany

  • Research Site

    Wiesbaden, 65199, Germany

  • Research Site

    Würzburg, 97080, Germany

  • Research Site

    Budapest, 1121, Hungary

  • Research Site

    Budapest, 1122, Hungary

  • Research Site

    Edelény, 3780, Hungary

  • Research Site

    Győr, 9024, Hungary

  • Research Site

    Kaposvár, 7400, Hungary

  • Research Site

    Miskolc, 3529, Hungary

  • Research Site

    Nyíregyháza, 4400, Hungary

  • Research Site

    Törökbálint, 2045, Hungary

  • Research Site

    Beersheba, 8410101, Israel

  • Research Site

    Haifa, 31096, Israel

  • Research Site

    Kfar Saba, 4428164, Israel

  • Research Site

    Petah Tikva, 49100, Israel

  • Research Site

    Tel Aviv, 64239, Israel

  • Research Site

    Tel Litwinsky, 52621, Israel

  • Research Site

    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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    Naples, 80131, Italy

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    Orbassano, 10043, Italy

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    Parma, 43126, Italy

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    Perugia, 06132, Italy

  • Research Site

    Roma, 00128, Italy

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    Roma, 00144, Italy

  • Research Site

    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

  • Research Site

    Lima, LIMA 11, Peru

  • Research Site

    Lima, LIMA 29, Peru

  • Research Site

    Lima, LIMA 34, Peru

  • Research Site

    Miraflores, 15046, Peru

  • Research Site

    Brzozów, 36-200, Poland

  • Research Site

    Bydgoszcz, 85-796, Poland

  • Research Site

    Gdansk, 80-219, Poland

  • Research Site

    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

  • Research Site

    Sucha Beskidzka, 34-200, Poland

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    Szczecin, 70-891, Poland

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    Warsaw, 02-781, Poland

  • Research Site

    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

  • Research Site

    Porto, 4200-319, Portugal

  • Research Site

    Vila Nova de Gaia, 4434-502, Portugal

  • Research Site

    Cluj-Napoca, 400015, Romania

  • Research Site

    Cluj-Napoca, 400058, Romania

  • Research Site

    Kazan', 420012, Russia

  • Research Site

    Moscow, 105229, Russia

  • Research Site

    Moscow, 115478, Russia

  • Research Site

    Saint Petersburg, 194291, Russia

  • Research Site

    Saint Petersburg, 197342, Russia

  • Research Site

    Saint Petersburg, 197758, Russia

  • Research Site

    Volgograd, 400138, Russia

  • Research Site

    Barcelona, 08003, Spain

  • Research Site

    Madrid, 08035, Spain

  • Research Site

    Madrid, 28034, Spain

  • Research Site

    Madrid, 28041, Spain

  • Research Site

    Málaga, 29010, Spain

  • Research Site

    Seville, 41013, Spain

  • Research Site

    Vigo(Pontevedra), 36204, Spain

  • Research Site

    Zaragoza, 50009, Spain

  • Research Site

    Linköping, 581 85, Sweden

  • Research Site

    Örebro, 701 85, Sweden

  • Research Site

    Uppsala, SE-751 85, Sweden

  • Research Site

    Ankara, 06230, Turkey (Türkiye)

  • Research Site

    Ankara, 06280, Turkey (Türkiye)

  • Research Site

    Istanbul, 34662, Turkey (Türkiye)

  • Research Site

    Istanbul, 34844, Turkey (Türkiye)

  • Research Site

    Izmir, 35100, Turkey (Türkiye)

  • Research Site

    Izmir, 35110, Turkey (Türkiye)

  • Research Site

    Manisa, 45030, Turkey (Türkiye)

  • Research Site

    Chernivtsі, 58013, Ukraine

  • Research Site

    Dnipro, 49102, Ukraine

  • Research Site

    Kharkiv Region, 61070, Ukraine

  • Research Site

    Kryvyi Rih, 50048, Ukraine

  • Research Site

    Kyiv, 03115, Ukraine

  • Research Site

    Sumy, 40022, Ukraine

  • Research Site

    Uzhhorod, 88000, Ukraine

  • Research Site

    Zaporizhzhia, 69040, Ukraine

  • Research Site

    Aberdeen, AB2 2ZB, United Kingdom

  • Research Site

    London, SW3 6JJ, United Kingdom

  • Research Site

    Manchester, M20 4BX, United Kingdom

  • Research Site

    Nottingham, NG5 1PB, United Kingdom

  • Research Site

    Sutton, SM2 5PT, United Kingdom

  • Research Site

    Wolverhampton, WV10 0QP, United Kingdom