Cure My Disease

Don't miss your cure!

 Log in / Sign up

New hope for early lung cancer: pill may keep disease from returning

NCT ID NCT05120349

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 07, 2026 · Updated 2 times

Summary

This phase 3 trial tests whether the targeted drug osimertinib (Tagrisso) can prevent lung cancer from returning in patients with early-stage (IA2-IA3) non-small cell lung cancer that has a specific EGFR mutation. About 390 participants who have had complete tumor removal surgery will receive either osimertinib or a placebo daily. The study measures how long they remain cancer-free and overall survival, with treatment continuing until the cancer returns or side effects become unacceptable.

What this could mean

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

Active substance
Osimertinib (Tagrisso), a targeted cancer pill
What this could lead to
If successful, this could offer a way to reduce the risk of early-stage lung cancer returning after surgery, potentially improving long-term survival.
What could go wrong
This is an early-stage cancer trial, and the benefit over placebo may be small. Side effects like rash, diarrhea, or lung inflammation are possible, and the drug must be taken indefinitely until recurrence or toxicity.

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

390 people

The number who actually took part.

Started

Feb 2022

Expected to finish

Nov 2032

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 years and older

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, at least ≥ 18 years. 2. NSCLC, of non-squamous histology. 3. Stage IA2 or IA3 disease, based on TNM8 classification. 4. Complete surgical resection (R0) of the primary NSCLC by lobectomy, bilobectomy, segmentectomy or sleeve resection. 5. Complete recovery from surgery at the time of randomisation. Study intervention cannot commence within 4 weeks following surgery. No more than 12 weeks may have elapsed between surgery and randomisation for participants. 6. World Health Organization performance status of 0 or 1. 7. Provision of tumour sample for central pathology assessment of pathologic risk factors and to assess EGFR mutation status prior to randomisation. 8. A tumour which harbours one of the 2 EGFR mutations (Ex19del, L858R) by cobas® EGFR Mutation Test v2 (Roche Diagnostics) or FoundationOne® test. 9. Minimum life expectancy of \> 6 months. 10. Females must be using highly effective contraceptive measures, and must have a negative pregnancy test prior to start of dosing if of child-bearing potential, or must have evidence of non-child-bearing potential. Male subjects must be willing to use barrier contraception. Exclusion Criteria 1. Mixed small cell and non-small cell cancer history. 2. Participants with incomplete (R1/R2) resection, or who have undergone pneumonectomy or only wedge resection. 3. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses; or active infection including HCV and HIV or active uncontrolled HBV infection. 4. History of another primary malignancy, including any known or suspected synchronous primary lung cancer except for malignancy treated with curative intent with no known active disease ≥ 5 years before the first dose of study intervention and of low potential risk for recurrence. 5. Any of the following cardiac criteria: * Mean resting QTcF interval \> 470 ms, obtained from triplicate ECGs performed at screening. * Any abnormalities in rhythm, conduction, or morphology of resting ECG, * Any factors that increase the risk of QTcF prolongation or risk of arrhythmic events. 6. History of interstitial lung disease. 7. Inadequate bone marrow reserve or organ function. 8. Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study intervention. 9. Prior treatment with any anticancer therapy for NSCLC (including chemotherapy, radiotherapy, immunotherapy, and EGFR-TKIs). 10. Major surgery or significant traumatic injury within 4 weeks of the first dose of study intervention. 11. Participants currently receiving medications or herbal supplements known to be strong inducers of CYP3A4.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Non small cell lung cancer are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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

Contacts and locations

Locations

  • Research Site

    Anchorage, Alaska, 99508, United States

  • Research Site

    Los Angeles, California, 90024, United States

  • Research Site

    Orange, California, 92868, United States

  • Research Site

    Grand Junction, Colorado, 81501, United States

  • Research Site

    Newark, Delaware, 19713, United States

  • Research Site

    Atlanta, Georgia, 30322, United States

  • Research Site

    Chicago, Illinois, 60612, United States

  • Research Site

    Frederick, Maryland, 21702, United States

  • Research Site

    Morristown, New Jersey, 07960, United States

  • Research Site

    Flushing, New York, 11355, United States

  • Research Site

    New York, New York, 10032, United States

  • Research Site

    New York, New York, 10065, United States

  • Research Site

    White Plains, New York, 10601, United States

  • Research Site

    Houston, Texas, 77030, United States

  • Research Site

    Fort Belvoir, Virginia, 22060, United States

  • Research Site

    Buenos Aires, C1431FWO, Argentina

  • Research Site

    CABA, C1012AAR, Argentina

  • Research Site

    Cipolletti, 8234, Argentina

  • Research Site

    La Plata, 1900, Argentina

  • Research Site

    Rosario, 2000, Argentina

  • Research Site

    Rosario, S2000CVB, Argentina

  • Research Site

    S.C. de Bariloche, 8400, Argentina

  • Research Site

    Barretos, 14784-400, Brazil

  • Research Site

    Belo Horizonte, 30380-090, Brazil

  • Research Site

    Porto Alegre, 90610-000, Brazil

  • Research Site

    Recife, 52010-075, Brazil

  • Research Site

    Rio de Janeiro, 22271-110, Brazil

  • Research Site

    São Paulo, 01327-001, Brazil

  • Research Site

    São Paulo, 04501-000, Brazil

  • Research Site

    Vancouver, British Columbia, V5Z 1M9, Canada

  • Research Site

    Montreal, Quebec, H4A 3J1, Canada

  • Research Site

    Toronto, M5G 2M9, Canada

  • Research Site

    Beijing, 100005, China

  • Research Site

    Beijing, 100029, China

  • Research Site

    Beijing, 100142, China

  • Research Site

    Beijing, 100210, China

  • Research Site

    Beijing, 100730, China

  • Research Site

    Beijing, 102218, China

  • Research Site

    Changchun, 130012, China

  • Research Site

    Changsha, 410013, China

  • Research Site

    Changsha, 430033, China

  • Research Site

    Chengdu, 610000, China

  • Research Site

    Fuzhou, 350014, China

  • Research Site

    Guangzhou, 510060, China

  • Research Site

    Guangzhou, 510100, China

  • Research Site

    Hangzhou, 310022, China

  • Research Site

    Harbin, 150049, China

  • Research Site

    Jinan, 250117, China

  • Research Site

    Nanjing, 210029, China

  • Research Site

    Shanghai, 200030, China

  • Research Site

    Shanghai, 200032, China

  • Research Site

    Shenzhen, 518116, China

  • Research Site

    Suzhou, 215006, China

  • Research Site

    Taiyuan, 030000, China

  • Research Site

    Xi'an, 710061, China

  • Research Site

    Xintai, 54031, China

  • Research Site

    Yangzhou, 225001, China

  • Research Site

    Zhengzhou, 450008, China

  • Research Site

    Berlin, 13125, Germany

  • Research Site

    Esslingen am Neckar, 73730, Germany

  • Research Site

    Georgsmarienhütte, 49124, Germany

  • Research Site

    Lübeck, 23538, Germany

  • Research Site

    München, 81377, Germany

  • Research Site

    Würzburg, 97067, Germany

  • Research Site

    Bari, 70124, Italy

  • Research Site

    Catania, 95100, Italy

  • Research Site

    Florence, 50134, Italy

  • Research Site

    Genova, 16132, Italy

  • Research Site

    Milan, 20141, Italy

  • Research Site

    Naples, 80131, Italy

  • Research Site

    Padova, 35128, Italy

  • Research Site

    Parma, 43100, Italy

  • Research Site

    Roma, 00144, Italy

  • Research Site

    Chiba, 260-0877, Japan

  • Research Site

    Fukuoka, 812-8582, Japan

  • Research Site

    Hiroshima, 734-8551, Japan

  • Research Site

    Kashiwa, 227-8577, Japan

  • Research Site

    Kōtoku, 135-8550, Japan

  • Research Site

    Kyoto, 606-8507, Japan

  • Research Site

    Niigata, 951-8566, Japan

  • Research Site

    Osaka, 541-8567, Japan

  • Research Site

    Sakai, 590-0197, Japan

  • Research Site

    Sendai, 981-0914, Japan

  • Research Site

    Shinjuku-ku, 160-0023, Japan

  • Research Site

    Sunto-gun, 411-8777, Japan

  • Research Site

    Wakayama, 641-8510, Japan

  • Research Site

    Kuala Lumpur, 59100, Malaysia

  • Research Site

    Kuala Selangor, 46050, Malaysia

  • Research Site

    Kuching, 93586, Malaysia

  • Research Site

    Pulau Pinang, 10450, Malaysia

  • Research Site

    Poznan, 60-569, Poland

  • Research Site

    Warsaw, 01-138, Poland

  • Research Site

    Bucharest, 022328, Romania

  • Research Site

    Bucharest, 050098, Romania

  • Research Site

    Perm, 614990, Russia

  • Research Site

    Saint Petersburg, 191036, Russia

  • Research Site

    Singapore, 169610, Singapore

  • Research Site

    Singapore, 308433, Singapore

  • Research Site

    Daegu, 42415, South Korea

  • Research Site

    Jinju, 52727, South Korea

  • Research Site

    Seoul, 03082, South Korea

  • Research Site

    Seoul, 05505, South Korea

  • Research Site

    Seoul, 07061, South Korea

  • Research Site

    Suwon, 16247, South Korea

  • Research Site

    Suwon, 16499, South Korea

  • Research Site

    Barcelona, 08041, Spain

  • Research Site

    Málaga, 29010, Spain

  • Research Site

    Valencia, 46010, Spain

  • Research Site

    Vigo, 36312, Spain

  • Research Site

    Zaragoza, 50009, Spain

  • Research Site

    Taichung, 40201, Taiwan

  • Research Site

    Taichung, 40705, Taiwan

  • Research Site

    Tainan, 70403, Taiwan

  • Research Site

    Taipei, 100, Taiwan

  • Research Site

    Taipei, 11217, Taiwan

  • Research Site

    Taipei, 114, Taiwan

  • Research Site

    Taipei, 235, Taiwan

  • Research Site

    Taoyuan, 333, Taiwan

  • Research Site

    Bangkok, 10300, Thailand

  • Research Site

    Bangkok, 10330, Thailand

  • Research Site

    Bangkok, 10700, Thailand

  • Research Site

    Hat Yai, 90110, Thailand

  • Research Site

    Khon Kaen, 40002, Thailand

  • Research Site

    Muang, 50200, Thailand

  • Research Site

    Ankara, 06010, Turkey (Türkiye)

  • Research Site

    Bursa, 16059, Turkey (Türkiye)

  • Research Site

    Istanbul, Turkey (Türkiye)

  • Research Site

    Izmir, 35040, Turkey (Türkiye)

  • Research Site

    Kadıkoy/Istanbul, 34722, Turkey (Türkiye)

  • Research Site

    Birmingham, B9 5SS, United Kingdom

  • Research Site

    Blackpool, FY3 8NR, United Kingdom

  • Research Site

    London, SE1 9RT, United Kingdom

  • Research Site

    London, SW10 9NH, United Kingdom

  • Research Site

    London, SW3 6NP, United Kingdom

  • Research Site

    Nottingham, NG5 1PB, United Kingdom

  • Research Site

    Wythenshawe, M23 9LT, United Kingdom

  • Research Site

    Hanoi, 100000, Vietnam

  • Research Site

    Ho Chi Minh City, 700000, Vietnam

  • Research Site

    Hồ Chí Minh, 700000, Vietnam

More trials for these conditions

Other studies related to the condition(s) this trial covers.