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Cancer patients get continued access to lifesaving drug in new study

NCT ID NCT05629234

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 10, 2026 · Updated 2 times

Summary

This study offers continued treatment with the cancer drug osimertinib to patients who have already benefited from it in a previous trial. The goal is to keep providing the drug while monitoring safety and side effects. About 37 adults with cancer who are still doing well on the drug will take part.

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

About 37 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

Feb 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 99 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. Provision of signed and dated, written Informed Consent Form (ICF). 2. Patient is currently deriving clinical benefit from continued treatment with osimertinib in an AstraZeneca parent study using osimertinib monotherapy which has met its endpoints or has otherwise stopped. 3. Patients should be using adequate contraceptive measures. Exclusion Criteria: 1. Ongoing, unresolved, Grade 3 or above toxicity requiring interruption of treatment at the time of the termination of the parent study. 2. Currently receiving treatment with any prohibited medication(s). 3. Concurrently enrolled in any other type of medical research judged not to be scientifically, or medically compatible with this study. 4. Permanent discontinuation from the parent study due to toxicity or disease progression. 5. Local access to commercially-available drug at no cost to the patient is permitted by local regulation. Exclusion Criteria for the sub-study: 1\. Active infection including active hepatitis C and Human immunodeficiency virus (HIV) infection or active uncontrolled Hepatitis B virus (HBV) infection. Screening for chronic conditions is not required. Patients with HBV infection are only eligible if they meet all the following criteria: * Demonstrated absence of HCV co-infection or history of HCV co-infection; * Demonstrated absence of HIV infection; * Patients receiving anti-viral treatment for at least 6 weeks prior to study treatment, HBV DNA is suppressed to \< 100 IU/mL, and transaminase levels are below ULN. Patients with a resolved or chronic HBV infection are eligible if they are: * Negative for HBsAg and positive for anti-HBc IgG. In addition, patients must be receiving anti-viral prophylaxis for 2 to 4 weeks prior to study treatment and 6 to 12 months (to be determined by hepatologist) post treatment; or * Positive for HBsAg, but for \> 6 months have had transaminases levels below ULN and HBV DNA levels below \< 100 IU/mL (ie, patients are in an inactive carrier state). In addition, patients must be receiving anti-viral prophylaxis for 2 to 4 weeks prior to study treatment. Should participants with HIV infection be included, patients are only eligible if they meet all the following criteria: * Undetectable viral RNA load for 6 months * CD4+ count of \> 350 cells/μL * No history of AIDS-defining opportunistic infection within the past 12 months (to be determined by hepatologist) post treatment * Stable for at least 4 weeks on anti-HIV medications.

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Conditions

The condition(s) this trial relates to.

cancer neoplasm

As listed by the trial registrant

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

Cancer

Contacts and locations

Locations

  • Research Site

    Beijing, 100142, China

  • Research Site

    Chongqing, 400042, China

  • Research Site

    Yangzhou, 225001, China

  • Research Site

    Zhengzhou, 450008, China

  • Research Site

    Villejuif, 94805, France

  • Research Site

    Kashiwa, 277-8577, Japan

  • Research Site

    George Town, 10450, Malaysia

  • Research Site

    Johor Bahru, 81100, Malaysia

  • Research Site

    Kuantan, 25100, Malaysia

  • Research Site

    Kuching, 93586, Malaysia

  • Research Site

    Szczecin, 70-419, Poland

  • Research Site

    Cheongju-si, 28644, South Korea

  • Research Site

    Donggu, 44033, South Korea

  • Research Site

    Goyang-si, 10408, South Korea

  • Research Site

    Seongnam-si, 13620, South Korea

  • Research Site

    Seoul, 03080, South Korea

  • Research Site

    Seoul, 03722, South Korea

  • Research Site

    Seoul, 06351, South Korea

  • Research Site

    Seoul, 06591, South Korea

  • Research Site

    Seoul, 5505, South Korea

  • Research Site

    Kaohsiung City, 83301, Taiwan

  • Research Site

    Taichung, 40705, Taiwan

  • Research Site

    Tainan, 704, Taiwan

  • Research Site

    Tainan, 736, Taiwan

  • Research Site

    Taipei, 112201, Taiwan

  • Research Site

    Taoyuan, 333, Taiwan

  • Research Site

    Nottingham, NG5 1PB, United Kingdom

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