New hope for stage III lung cancer: targeted pill may delay progression

NCT ID NCT03521154

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Aug 05, 2026 · Updated 3 times

Summary

This phase 3 study tests whether the targeted drug osimertinib can keep stage III EGFR-mutant lung cancer from progressing after initial chemoradiation. About 216 participants will receive either osimertinib or a placebo daily until their cancer worsens or side effects become unacceptable. The main goal is to see how long the cancer stays under control.

What this could mean

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

Active substance: Osimertinib (a targeted drug that blocks EGFR mutations in cancer cells)
What this could lead to: If successful, this could offer a new maintenance option to delay cancer progression for people with stage III EGFR-mutant lung cancer after chemoradiation.
What could go wrong: This is a phase 3 trial, but results are not yet final. The drug may not significantly improve survival, and side effects like lung inflammation or skin reactions are possible.

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

216 people

The number who actually took part.

Started

Jul 2018

Expected to finish

Oct 2027

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 1. Male or female aged at least 18 years. 2. Patients with histologically documented NSCLC of predominantly non-squamous Pathology who present with locally advanced, unresectable (Stage III) disease (according to Version 8 of the International Association for the Study of Lung Cancer \[IASLC\] Staging Manual in Thoracic Oncology). 3. The tumor harbours one of the two common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations, assessed by cobas® EGFR Mutation Test v2 (Roche Diagnostics) or FoundationOne® test in a CLIA certified (USA sites) or an accredited local laboratory (sites outside of the USA) or by central testing (cobas® v2 only). 4. Patients must have received either concurrent chemoradiation or sequential chemoradiation including at least 2 cycles of platinum based chemotherapy and a total dose of radiation of 60 Gy ±10% (54 to 66 Gy). 5. Chemoradiation must be completed ≤6 weeks prior to randomization. 6. Patients must not have had disease progression during or following definitive platinum-based, chemoradiation therapy. 7. World Health Organization (WHO) performance status of 0 or 1. 8. Life expectancy \>12 weeks at Day 1. 9. Female patients who are not abstinent (in line with the preferred and usual lifestyle choice) must be using adequate contraceptive measures, must not be breast feeding, and must have a negative pregnancy test prior to first dose of study drug; or female patients must have an evidence of non-childbearing potential. Exclusion Criteria 1. Mixed small cell and non-small cell lung cancer histology 2. History of interstitial lung disease (ILD) prior to chemoradiation 3. Symptomatic pneumonitis following chemoradiation 4. Any unresolved toxicity Common Terminology Criteria for Adverse Events (CTCAE) \> Grade 2 from the prior chemoradiation therapy 5. Any of the following cardiac criteria: * Mean resting corrected QT interval (QTc) \>470 msec, obtained from 3 ECGs * Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG * Patient with any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval and cause Torsades de Pointes 6. Inadequate bone marrow reserve or organ function 7. History of other malignancies, except: adequately treated non-melanoma skin cancer or lentigo maligna , curatively treated in-situ cancer, or other solid tumors curatively treated with no evidence of disease for \> 5 years following the end of treatment and which, in the opinion of the treating physician, do not have a substantial risk of recurrence of the prior malignancy. 8. 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). 9. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of osimertinib 10. Prior treatment with any prior chemotherapy, radiation therapy, immunotherapy or investigational agents for NSCLC outside of that received in the definitive setting for Stage III disease (chemotherapy and radiotherapy in SCRT and CCRT regimens is allowed for treatment of Stage III disease). 11. Prior treatment with EGFR-TKI therapy 12. Major surgery as defined by the investigator within 4 weeks of the first dose of study drug. 13. Patients currently receiving (unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers of CYP3A4 (at least 3 weeks prior to receiving the first dose of study drug). 14. Contraindication to MRI, including but not limited to, claustrophobia, pace makers, metal implants, intracranial surgical clips and metal foreign bodies

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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.

Non-small cell lung cancer (stage III)

Contacts and locations

Locations

Research Site

Duarte, California, 91010, United States
Research Site

Atlanta, Georgia, 30322, United States
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Florham Park, New Jersey, 07932, United States
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Salt Lake City, Utah, 84106, United States
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Madison, Wisconsin, 53792, United States
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Ciudad Autónoma de Bs. As., 1426, Argentina
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Ciudad Autónoma de Bs. As., C1199ABB, Argentina
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Mar del Plata, 7600, Argentina
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Rosario, 2000, Argentina
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San Salvador de Jujuy, 4600, Argentina
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Barretos, 14784-400, Brazil
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Curitiba, 81520-060, Brazil
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Florianópolis, 88034-000, Brazil
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Fortaleza, 60336-045, Brazil
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Porto Alegre, 90160-093, Brazil
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Porto Alegre, 90610-000, Brazil
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Ribeirão Preto, 14021-636, Brazil
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São Paulo, 01221-0100, Brazil
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São Paulo, 01246-000, Brazil
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Beijing, 100021, China
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Beijing, 100730, China
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Changchun, 130000, China
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Changsha, 410013, China
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Chengdu, 610041, China
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Guangzhou, 510100, China
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Hangzhou, 310003, China
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Hangzhou, 310006, China
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Hangzhou, 310022, China
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Jinan, 250117, China
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Linhai, 317000, China
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Shanghai, 200030, China
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Shanghai, 200032, China
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Ürümqi, 830099, China
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Wuhan, 430022, China
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Wuhan, 430030, China
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Budapest, 1083, Hungary
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Budapest, 1121, Hungary
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Gyöngyös - Mátraháza, 3200, Hungary
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Pécs, 7623, Hungary
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Bangalore, 560068, India
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Gurgaon, 122001, India
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Hubli, 580025, India
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Karamsad, 388325, India
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Kolkata, 700160, India
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Nashik, 422002, India
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New Delhi, 110063, India
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New Delhi, 110085, India
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New Delhi, 11029, India
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Hiroshima, 734-8551, Japan
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Kanazawa, 920-8641, Japan
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Kashiwa, 227-8577, Japan
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Nagoya, 460-0001, Japan
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Niigata, 951-8566, Japan
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Osaka, 541-8567, Japan
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Sakaishi, 591-8555, Japan
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Sapporo, 003-0804, Japan
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Sayama, 589-8511, Japan
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Sendai, 981-0914, Japan
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Shinjuku-ku, 160-0023, Japan
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Sunto-gun, 411-8777, Japan
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Yokohama, 241-8515, Japan
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George Town, 10450, Malaysia
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Kuala Lumpur, 59100, Malaysia
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Kuala Selangor, 46050, Malaysia
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Mérida, 97134, Mexico
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Lima, LIMA 31, Peru
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Lima, Lima 32, Peru
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Lima, LIMA 34, Peru
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Lima, LIMA 41, Peru
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San Isidro, 27, Peru
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Kazan', 420029, Russia
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Kostroma, 156005, Russia
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Moscow, 121205, Russia
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Novisibirsk, 630082, Russia
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Obninsk, 249036, Russia
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Saint Petersburg, 197022, Russia
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Saint Petersburg, 197758, Russia
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Ufa, 450054, Russia
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Cheongju-si, 28644, South Korea
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Incheon, 21565, South Korea
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Seongnam-si, 13620, South Korea
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Seoul, 05505, South Korea
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Seoul, 06351, South Korea
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Barcelona, 08003, Spain
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Madrid, 28040, Spain
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Madrid, 28046, Spain
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Málaga, 29010, Spain
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San Sebastián, 20014, Spain
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Seville, 41009, Spain
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Valencia, 46009, Spain
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Kaohsiung City, 83301, Taiwan
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Taichung, 402, Taiwan
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Taichung, 40447, Taiwan
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Taichung, 40705, Taiwan
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Tainan, 70403, Taiwan
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Taipei, 10002, Taiwan
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Taipei, 11217, Taiwan
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Taoyuan, 00333, Taiwan
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Bangkok, 10300, Thailand
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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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Khon Kaen, 40002, Thailand
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Lampang, 52000, Thailand
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Mueang, 50200, Thailand
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Adana, 01120, Turkey (Türkiye)
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Adapazarı, 54290, Turkey (Türkiye)
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Ankara, 06280, Turkey (Türkiye)
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Ankara, 6200, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Istanbul, 34030, Turkey (Türkiye)
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Istanbul, 34854, Turkey (Türkiye)
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Izmir, 35620, Turkey (Türkiye)
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Hanoi, 100000, Vietnam
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Hà Nội, 100000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
Research Site

Ho Chi Minh City, 70000, Vietnam

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