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New combo therapy shows promise for Hard-to-Treat lung cancer

NCT ID NCT06525246

Disease control Sponsor: Ono Pharmaceutical Co., Ltd. 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This early-phase study tested a new drug called ONO-7475 combined with the standard targeted therapy osimertinib in 78 people with advanced EGFR-mutated non-small cell lung cancer. The goal was to see if the combination is safe and tolerable. Participants had stage IIIB, IIIC, IV, or recurrent lung cancer not suitable for radiation. The study measured side effects, drug levels in the body, and how well the cancer responded.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

78 people

The number who actually took part.

Started

Aug 2021

Finished

Jun 2025

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

20 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. Patients with stage IIIB/IIIC/IV or recurrent NSCLC, which is unsuitable for radical irradiation 2. Patients with confirmed EGFR gene exon 19 deletion or EGFR gene exon 21 mutation(L858R)and who are scheduled to receive osimertinib 3. Patient has an ECOG performance status of 0-1 Exclusion Criteria: 1. Patients with severe complication 2. Patients with multiple primary cancers

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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.

EGFR mutation-related tumors Recurrent non small cell lung cancer Stage IIIB non-small cell lung cancer Stage IIIC non-small cell lung cancer Stage IV non-small cell lung cancer

Contacts and locations

Locations

  • Hyogo College Of Medicine College Hospital

    Nishinomiya, Hyōgo, Japan

  • Kanagawa Cancer Center

    Yokohama, Kanagawa, Japan

  • Kitasato University Hospital

    Sagamihara-shi, Kanagawa, Japan

  • Kobe City Medical Center General Hospital

    Kobe, Hyōgo, Japan

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, Ehime, Japan

  • Nigata Cancer Center Hospital

    Niigata, Niigata, Japan

  • Osaka International Cancer Institute

    Osaka, Osaka, Japan

  • Osaka Medical and Pharmaceutical University Hospital

    Takatsuki, Osaka, Japan

  • Saitama Cancer Center

    Ina, Kitaadati-gun, Saitama, Japan

  • Shizuoka Cancer Center

    Nagaizumi-chō, Sunto-gun, Shizuoka, Japan

  • The Cancer Institute Hospital Of JFCR

    Koto-Ku, Tokyo, Japan

  • Tokyo Medical University Hospital

    Shinjuku-Ku, Tokyo, Japan

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, Kyoto, Japan

More trials for these conditions

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