Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

5-Year pill course aims to keep lung cancer from returning

NCT ID NCT05526755

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 04, 2026 · Updated 2 times

Summary

This study tests whether taking osimertinib for 5 years after surgery can prevent lung cancer from coming back in people with a specific EGFR mutation. About 188 adults with stage II-IIIB non-small cell lung cancer who had their tumor fully removed will take the drug. The main goal is to see how long they stay cancer-free.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

188 people

The number who actually took part.

Started

Mar 2023

Expected to finish

Nov 2029

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. Histologically confirmed diagnosis of primary NSCLC on predominantly non-squamous histology. 3. Magnetic Resonance Imaging (MRI) or contrast computed tomography (CT) scan of the brain. 4. Participants must be classified post-operatively as Stage II, IIIA, or IIIB on the basis of surgical pathologic criteria. 5. Confirmation by the local laboratory that the tumour harbours one of the two common EGFR mutations (Ex19del, L858R), either alone or in combination with other EGFR mutations including de novo EGFR mutation resulting in substitution of threonine with methionine at amino acid position 790 in exon 20 of EGFR (T790M) or uncommon EGFR mutations G719X, S768I, and L861Q, either alone, in combination with each other, or in combination with other uncommon EGFR mutations (excluding all exon 20 insertions) (Uncommon EGFRm Cohort). 6. Complete surgical resection of the primary NSCLC is mandatory. All gross disease must have been removed at the end of surgery. All surgical margins of resection must be negative for tumour. 7. Complete recovery from surgery and standard post-operative therapy (if applicable) at start of study intervention. 8. World Health Organisation Performance Status of 0 to 1. 9. Female participants must be using highly effective contraceptive measures, and must have a negative pregnancy test prior to start of dosing if of childbearing potential. 10. Male participants must use effective barrier contraception. Exclusion Criteria: 1. Major surgery (including primary tumour surgery, excluding placement of vascular access) within 4 weeks prior to the first dose of study drug. 2. Participants currently receiving medications or herbal supplements known to be strong inducers of CYP3A4 (at least 3 weeks prior to first dose). 3. Participants who have had only segmentectomies or wedge resections. 4. History of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer, or other solid tumours curatively treated with no evidence of disease for \> 5 years before the start of study intervention. 5. Treatment with any of the following: * Pre-operative or post-operative or planned radiation therapy for the current lung cancer. * Pre-operative (neo-adjuvant) platinum-based or other chemotherapy. * Any prior anti-cancer or immunological therapy, including investigational therapy, for treatment of NSCLC other than standard platinum-based doublet post-operative adjuvant chemotherapy. * Prior treatment with neoadjuvant or adjuvant EGFR tyrosine kinase inhibitor (TKI). 6. 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. 7. Any of the following cardiac criteria: * Mean resting corrected QT (QTc) interval \> 470 msec, obtained from 3 electrocardiograms (ECGs). * Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG. * Any factors that increase the risk of QTc prolongation or risk of arrhythmic events. * Heart failure, congenital long QT interval (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 (TdP). 8. Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD. 9. Inadequate bone marrow reserve or organ function. 10. Women who are breastfeeding.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Stage II-IIIB non-small cell lung carcinoma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

Stage II-IIIB non-small cell lung carcinoma

Contacts and locations

Locations

  • Research Site

    Santa Rosa, California, 95403, United States

  • Research Site

    Las Vegas, Nevada, 89169, United States

  • Research Site

    White Plains, New York, 10601, United States

  • Research Site

    Hong Kong, 150001, Hong Kong

  • Research Site

    Hong Kong, 999077, Hong Kong

  • Research Site

    Hong Kong, Hong Kong

  • Research Site

    Avellino, 83100, Italy

  • Research Site

    Brescia, 25123, Italy

  • Research Site

    Lecce, 73100, Italy

  • Research Site

    Milan, 20141, Italy

  • Research Site

    Naples, 80131, Italy

  • Research Site

    Palermo, 90146, Italy

  • Research Site

    Peschiera del Garda, 37019, Italy

  • Research Site

    Reggio Emilia, 42123, Italy

  • Research Site

    Sondrio, 23100, Italy

  • Research Site

    Terni, 05100, Italy

  • Research Site

    Udine, 33100, Italy

  • Research Site

    Kuala Lumpur, 59100, Malaysia

  • Research Site

    Kuantan, 25100, Malaysia

  • Research Site

    Kuching, 93586, Malaysia

  • Research Site

    Cebu, 6000, Philippines

  • Research Site

    Manila, 1000, Philippines

  • Research Site

    Quezon City, 1100, Philippines

  • Research Site

    Singapore, 119074, Singapore

  • Research Site

    Busan, 48108, South Korea

  • Research Site

    Busan, 49241, South Korea

  • Research Site

    Cheongju-si, 28644, South Korea

  • Research Site

    Daejeon, 35015, South Korea

  • Research Site

    Goyang-si, 410-769, South Korea

  • Research Site

    Gyeonggi-do, 13620, South Korea

  • Research Site

    Incheon, 21565, South Korea

  • Research Site

    Seongnam-si, 13496, South Korea

  • Research Site

    Seoul, 03080, South Korea

  • Research Site

    Seoul, 03722, South Korea

  • Research Site

    Seoul, 05030, South Korea

  • Research Site

    Seoul, 05505, South Korea

  • Research Site

    Seoul, 06273, South Korea

  • Research Site

    Seoul, 06351, South Korea

  • Research Site

    Seoul, 06591, South Korea

  • Research Site

    Badalona, 08013, Spain

  • Research Site

    Barcelona, 08036, Spain

  • Research Site

    Bilbao, 48013, Spain

  • Research Site

    Granada, 18014, Spain

  • Research Site

    L'Hospitalet de Llobregat, 08907, Spain

  • Research Site

    Madrid, 28007, Spain

  • Research Site

    Seville, 41009, Spain

  • Research Site

    Valencia, 46026, Spain

  • Research Site

    Hualien City, 970, Taiwan

  • Research Site

    Kaohsiung City, 82445, Taiwan

  • Research Site

    Kaohsiung City, 833401, Taiwan

  • Research Site

    Taichung, 40705, Taiwan

  • Research Site

    Taipei, 10449, Taiwan

  • Research Site

    Bangkok, 10700, Thailand

  • Research Site

    Songkhla, 90110, Thailand

  • Research Site

    London, SW3 6JJ, United Kingdom

  • Research Site

    Nottingham, NG5 1PB, United Kingdom