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

New hope for ALK lung cancer: first human trial of AQUA07 begins

NCT ID NCT07617337

Disease control Sponsor: Chugai Pharmaceutical Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 18, 2026 · Updated 4 times

Summary

This early-stage trial tests a new oral drug called AQUA07, alone or with another drug (lorlatinib), in about 102 people with ALK-positive non-small cell lung cancer that has spread or cannot be removed. The main goals are to check safety, find the right dose, and see how the body handles the drug. Participants must have already tried at least one ALK-targeted therapy.

What this could mean

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

Active substance
AQUA07 (oral drug) and lorlatinib (oral drug)
What this could lead to
If successful, this could lead to a new treatment option for people with ALK-positive lung cancer who have already tried other therapies.
What could go wrong
This is a very early (Phase 1) trial with only 102 participants, so it is primarily testing safety and dosing. It is too soon to know if the drug will work or have serious side effects.

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

About 102 people

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

Started

Jul 2026

Expected to finish

Aug 2030

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: * Age ≥ 18 years (or ≥ 20 years if required by local regulation) at time of signing Informed Consent Form * Previously treated with at least one ALK-TKI regardless of prior chemotherapy treatment (Patients who have received only crizotinib as prior ALK-TKI treatment will not be allowed.) * Histologically or cytologically (excluding sputum cytology) proven diagnosis of locally advanced unresectable or metastatic ALK-positive NSCLC, who have experienced disease progression during or following their most recent systemic therapy or have discontinued the therapy due to unacceptable toxicity * Measurable disease per RECIST v1.1 * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Ability and willingness to take oral medication(s) * Adequate organ function and bone marrow reserve Exclusion Criteria: * Prior toxicities from anti-cancer therapy which have not resolved to Grade ≤ 1 per NCI CTCAE v5.0 excluding alopecia, vitiligo, or endocrinopathies manageable with replacement therapy * Symptomatic, active CNS metastases or untreated CNS metastases requiring any definitive therapy. * Severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or renal disease, or active infection), or with a history or complication of interstitial lung disease * Significant cardiovascular disease * Inadequately controlled hypertension * (Part B only) Patients with prior lorlatinib treatment who experienced serious lorlatinib-related toxicities, or who experienced toxicities considered inappropriate for study participation at the discretion of the Investigator

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for ALK-positive non-small-cell lung cancer 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.

ALK-positive non-small-cell lung cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aichi Cancer Center Hospital

    RECRUITING

    Nagoya, Aichi-ken, 464-8681, Japan

  • Kindai University Hospital

    RECRUITING

    Sakai, Osaka, 590-0197, Japan

  • National Cancer Center Hospital

    RECRUITING

    Chuo-ku, Tokyo, 135-8550, Japan

  • National Cancer Center Hospital East

    RECRUITING

    Kashiwa, Chiba, 277-8577, Japan

  • Shizuoka Cancer Center

    RECRUITING

    Nagaizumi-cho, Shizuoka, 411-8777, Japan

  • The Cancer Institute Hospital of JFCR (Japanese Foundation for Cancer Research)

    RECRUITING

    Koto-Ku, Tokyo, 135-8550, Japan

  • The University of Texas MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

More trials for these conditions

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