New lung cancer pill outperforms standard treatment in major trial

NCT ID NCT02296125

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new targeted therapy, AZD9291 (osimertinib), against the usual targeted drugs for people with a specific genetic mutation (EGFR) in advanced non-small cell lung cancer. Over 600 participants received either the new drug or standard care. The main goal was to see how long the cancer stayed under control. Results showed that AZD9291 significantly delayed cancer progression compared to standard treatment.

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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

674 people

The number who actually took part.

Started

Dec 2014

Finished

Nov 2025

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 100 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: 1. Male or female, aged at least 18 years. 2. Pathologically confirmed adenocarcinoma of the lung. 3. Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy. 4. The tumour harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R). 5. Mandatory provision of an unstained, archived tumour tissue sample in a quantity sufficient to allow for central analysis of EGFR mutation status. 6. Patients must be treatment-naïve for locally advanced or metastatic NSCLC and eligible to receive first-line treatment with gefitinib or erlotinib as selected by the participating centre. Prior adjuvant and neo-adjuvant therapy is permitted(chemotherapy, radiotherapy, investigational agents). 7. Provision of informed consent prior to any study specific procedures, sampling, and analysis. 8. World Health Organization Performance Status of 0 to 1 with no clinically significant deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks Exclusion Criteria: 1. Treatment with any of the following: * Prior treatment with any systemic anti-cancer therapy for locally advanced/metastatic NSCLC. * Prior treatment with an EGFR-TKI. * Major surgery within 4 weeks of the first dose of study drug. * Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug. * Patients currently receiving medications or herbal supplements known to be potent inducers of cytochrome P450 (CYP) 3A4. * Alternative anti-cancer treatment * Treatment with an investigational drug within five half-lives of the compound or any of its related material. 2. Any concurrent and/or other active malignancy that has required treatment within 2 years of first dose of study drug. 3. Spinal cord compression, symptomatic and unstable brain metastases, except for those patients who have completed definitive therapy, are not on steroids, have a stable neurologic status for at least 2 weeks after completion of the definitive therapy and steroids. 4. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses; or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). 5. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of AZD9291. 6. Any of the following cardiac criteria: * Mean resting corrected QT interval (QTc) \>470 msec, obtained from 3 ECGs, using the screening clinic ECG machine-derived QTcF value. * Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG. * Any patient with any factors that increase the risk of QTc prolongation or risk of arrhythmic events or unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval. 7. Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD. 8. Involvement in the planning and/or conduct of the study

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Conditions

The condition(s) this trial relates to.

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 EGFR sensitising mutation positive non small cell lung cancer

Contacts and locations

Locations

Research Site

Anaheim, California, 92801, United States
Research Site

Santa Rosa, California, 95403, United States
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West Hills, California, 91307, United States
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Tampa, Florida, 33612, United States
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Atlanta, Georgia, 30318, United States
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Atlanta, Georgia, 30322, United States
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Marietta, Georgia, 30060, United States
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Louisville, Kentucky, 40202, United States
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Bethesda, Maryland, 20817, United States
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Boston, Massachusetts, 02215, United States
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Minneapolis, Minnesota, 55407, United States
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Lebanon, New Hampshire, 03756, United States
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Salisbury, North Carolina, 28144, United States
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Burlington, Vermont, 05401, United States
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Camperdown, 2050, Australia
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Chermside, 4032, Australia
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Clayton, 3168, Australia
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Heidelberg, 3084, Australia
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Kogarah, 2217, Australia
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Nedlands, 6009, Australia
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Woolloongabba, 4102, Australia
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
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Roeselare, 8800, Belgium
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Porto Alegre, 90610-000, Brazil
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Sofia, 1330, Bulgaria
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Edmonton, Alberta, T6G 1Z2, Canada
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Hamilton, Ontario, L8V 5C2, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M5G 1X5, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Beijing, 100071, China
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Beijing, 100853, China
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Changchun, 130012, China
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Changchun, 130021, China
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Chongqing, 400037, China
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Chongqing, 400038, China
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Chongqing, 400042, China
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Fuzhou, 350025, China
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Guangzhou, 510080, China
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Hangzhou, 310022, China
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Nanjing, 210029, China
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Nanning, 530021, China
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Shanghai, 200433, China
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Shenyang, 110001, China
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Suzhou, 215006, China
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Ürümqi, 830000, China
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Wuhan, 430071, China
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Xi'an, 710038, China
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Xi'an, 710061, China
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Yangzhou, 225001, China
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Ostrava, 708 52, Czechia
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Caen, F-14033, France
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Créteil, 94010, France
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Lyon, 69373, France
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Nantes, 44202, France
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Toulon Naval, 83800, France
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Villejuif, 94805, France
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Bad Berka, 99437, Germany
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Berlin, 13125, Germany
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Gauting, 82131, Germany
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Halle, 06120, Germany
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Heidelberg, 69126, Germany
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Karlsruhe, 76137, Germany
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Lübeck, 23538, Germany
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München, 81925, Germany
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Villingen-Schwenningen, 78052, Germany
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Farkasgyepü, 8582, Hungary
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Gyöngyös - Mátraháza, 3200, Hungary
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Miskolc, 3529, Hungary
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Székesfehérvár, 8000, Hungary
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Tatabánya, 2800, Hungary
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Zalaegerszeg, 8900, Hungary
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Haifa, 31999, Israel
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Kfar Saba, 4428164, Israel
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Petah Tikva, 49100, Israel
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Tel Litwinsky, 52621, Israel
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Cremona, 26100, Italy
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Lecce, 73100, Italy
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Lecco, 23900, Italy
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Orbassano, 10043, Italy
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Parma, 43126, Italy
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Roma, 00144, Italy
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Sondrio, 23100, Italy
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Terni, 05100, Italy
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Chūōku, 104-0045, Japan
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Fukuoka, 812-8582, Japan
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Hirakata-shi, 573-1191, Japan
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Kanazawa, 920-8641, Japan
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Kashiwa, 277-8577, Japan
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Kobe, 650-0047, Japan
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Matsuyama, 791-0280, Japan
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Natori-shi, 981-1293, Japan
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Osaka, 541-8567, Japan
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Osakasayama-shi, 589-8511, Japan
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Sagamihara-shi, 252-0375, Japan
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Sakaishi, 591-8555, Japan
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Sendai, 980-0873, Japan
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Sunto-gun, 411-8777, Japan
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Yokohama, 232-0024, Japan
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Yokohama, 236-0051, Japan
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Yokohama, 240-8555, Japan
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Yokohama, 241-8515, Japan
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Kuala Lumpur, 59100, Malaysia
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Kuantan, 25100, Malaysia
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Kuching, 93586, Malaysia
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Cebu, 6000, Philippines
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Manila, 1000, Philippines
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Quezon City, 1100, Philippines
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Brzozoów, 36-200, Poland
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Otwock, 05-400, Poland
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Poznan, 60-569, 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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Lisbon, 1769-001, Portugal
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Porto, 4200-072, Portugal
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Vila Nova de Gaia, 4434-502, Portugal
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Bucharest, 022328, Romania
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Bucharest, 050098, Romania
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Craiova, 200347, Romania
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Saint Petersburg, 197022, Russia
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Saint Petersburg, 197758, Russia
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Saint Petersburg, 198255, Russia
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Cheongju-si, 28644, South Korea
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Incheon, 405-760, South Korea
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Seongnam-si, 13620, South Korea
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Seoul, 02841, South Korea
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Seoul, 03722, South Korea
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Seoul, 06591, South Korea
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Seoul, 5030, South Korea
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A Coruña, 15006, Spain
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Barcelona, 08041, Spain
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Barcelona, 08221, Spain
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Barcelona, 08907, Spain
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Lleida, 25198, Spain
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Lugo, 27003, Spain
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Madrid, 28040, Spain
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Málaga, 29010, Spain
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Seville, 41014, Spain
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Zaragoza, 50009, Spain
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Linköping, 581 85, Sweden
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Lucerne, 6000, Switzerland
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Winterthur, 8401, Switzerland
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Zurich, 8091, Switzerland
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Kaohsiung City, 833, Taiwan
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Taichung, 402, Taiwan
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Tainan, 704, Taiwan
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Tainan, 73657, Taiwan
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Taoyuan City, 333, Taiwan
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Bangkok, 10330, Thailand
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Bangkok, 10400, Thailand
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Bangkok, 10700, Thailand
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Hat Yai, 90110, Thailand
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Muang, 50200, Thailand
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Ankara, 6500, Turkey (Türkiye)
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Istanbul, 34069, Turkey (Türkiye)
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Izmir, 35100, Turkey (Türkiye)
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Dnipro, 49102, Ukraine
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Kryvyi Rih, 50048, Ukraine
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Lviv, 79031, Ukraine
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Sumy, 40022, Ukraine
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Edinburgh, EH4 2XU, United Kingdom
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London, NW1 2BU, United Kingdom
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Maidstone, ME16 9QQ, United Kingdom
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Withington, M20 4BX, United Kingdom
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Hanoi, 100000, Vietnam
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Hanoi, 10000, Vietnam
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Ho Chi Minh City, 70000, Vietnam