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New drug cocktail shows promise for Hard-to-Treat lung cancer

NCT ID NCT05801029

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 09, 2026 · Updated 2 times

Summary

This study tests whether combining two targeted drugs, osimertinib and amivantamab, can safely control advanced lung cancer that has a specific EGFR gene mutation. About 60 adults with newly diagnosed or recurrent non-small cell lung cancer that cannot be surgically removed will receive the drug combination as their first treatment. The main goals are to check side effects and see how long the cancer stays under control.

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

60 people

The number who actually took part.

Started

Jul 2023

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: * Histologically or cytologically documented non-squamous NSCLC. NSCLC of mixed histology is allowed. * Newly diagnosed locally advanced or metastatic NSCLC or recurrent non-squamous NSCLC, not amenable to curative surgery or radiotherapy. * WHO PS of 0 to 1 with no deterioration over the 2 weeks prior to enrolment. * Minimum life expectancy \> 12 weeks at Day 1. * Confirmation by the local laboratory that the tumour harbours one of the 2 common EGFRm known to be associated with (Epidermal Growth Factor Receptor- Tyrosine Kinase Inhibitor) EGFR-TKI sensitivity. * At least 1 lesion that can be accurately measured at baseline as ≥10 mm in the longest diameter with computed tomography (CT) or magnetic resonance imaging (MRI) and that is suitable for accurate repeated measurements. * Contraceptive use by males or females should be consistent with local regulations Exclusion Criteria: * Any evidence of diseases, history of allogenic organ transplant, which in the investigator's opinion makes it undesirable for the participant to participate in the study or would jeopardise compliance with protocol. * Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the osimertinib, or previous significant bowel resection that would preclude adequate absorption distribution, metabolism, or excretion of osimertinib. * History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥2 years. * Any unresolved toxicities from prior therapy with Common Terminology Criteria for Adverse Events CTCAE) Grade ≥1, at the time of first dose of study intervention, with the exception of alopecia and Grade 2 prior platinum therapy related neuropathy. * Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring corticosteroids for at least 2 weeks prior to start of study intervention. * Active infection, including tuberculosis and infections with HBV (verified by known positive HBsAg result) or HCV. * Should participants with HIV infection be included, patients are only eligible if they meet the criteria per protocol. * Patient with protocol defined cardiac issue. * History of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD. * Any concomitant medications known to be associated with Torsade de Pointes. * Prior exposure to any systemic anti-cancer therapy for advanced NSCLC not amenable to curative surgery or radiation including chemotherapy, biologic therapy, immunotherapy, or any investigational drug. * Any concurrent anti-cancer treatment without an adequate washout period prior to the first dose of study intervention. * Palliative radiotherapy with a limited field of radiation within 2 weeks, or with wide field of radiation or to more than 30% of the bone marrow within 4 weeks, prior to the first dose of study intervention. * Major surgical procedure or significant traumatic injury. * Current use of medications or herbal supplements known to be strong inducers of CYP 3A4. * Prior treatment with an EGFR-TKI. * Participants with a history of hypersensitivity, or intolerance to the active or inactive excipients of osimertinib, amivantamab, or recommended pre-treatments of amivantamab or drugs with a similar chemical structure or class to these drugs.

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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 (NSCLC)

Contacts and locations

Locations

  • Research Site

    Hong Kong, 150001, Hong Kong

  • Research Site

    Hong Kong, 999077, Hong Kong

  • Research Site

    Hong Kong, Hong Kong

  • Research Site

    George Town, 10990, Malaysia

  • Research Site

    Kota Bharu, 15586, Malaysia

  • Research Site

    Kuala Lumpur, 50586, Malaysia

  • Research Site

    Kuala Lumpur, 59100, Malaysia

  • Research Site

    Kuantan, 25100, Malaysia

  • Research Site

    Kuching, 93200, Malaysia

  • Research Site

    Singapore, 169610, Singapore

  • Research Site

    Singapore, 308433, Singapore

  • Research Site

    Anyang-si, 14068, South Korea

  • Research Site

    Busan, 49241, South Korea

  • Research Site

    Daegu, 42415, South Korea

  • Research Site

    Seoul, 08308, South Korea

  • Research Site

    Seoul, 5030, South Korea

  • Research Site

    Kaohsiung City, 82445, Taiwan

  • Research Site

    Taichung, 404, Taiwan

  • Research Site

    Taichung, 40705, Taiwan

  • Research Site

    Tainan, 73657, Taiwan

  • Research Site

    Taipei, 10048, Taiwan

  • Research Site

    Taipei, 110, Taiwan

  • Research Site

    Yunlin, 640, Taiwan

  • Research Site

    Bangkok, 10330, Thailand

  • Research Site

    Bangkok, 10400, Thailand

  • Research Site

    Bangkok, 10700, Thailand

  • Research Site

    Chiang Mai, 50200, Thailand

  • Research Site

    Songkhla, 90110, Thailand

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