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New hope for lung cancer patients who've run out of options?

NCT ID NCT07374614

Disease control Sponsor: Peking University Shenzhen Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study is for people with a specific type of advanced lung cancer (ALK-positive) that has gotten worse during or after treatment with the drug lorlatinib. Researchers want to see if a different drug, iruplinalkib, can help control the cancer for a longer time. About 20 adults will take part, and the study will track how long the cancer stays under control and any 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.

Participants

About 20 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

ALK-positive lung adenocarcinoma patients who receive Iruplinalkib after lorlatinib treatment.

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: 1. Population: Male or female patients aged ≥18 years. 2. Diagnosis: Histologically or cytologically confirmed advanced lung adenocarcinoma. 3. Molecular Status: Documentation of ALK rearrangement confirmed by a validated test (e.g., NGS, IHC, FISH). 4. Prior Therapy: Prior treatment with lorlatinib (in any line of therapy), with documented disease progression or intolerance. 5. Current Therapy: Initiated treatment with iruplinalkib in the real-world setting. 6. Measurability: Presence of at least one evaluable lesion (measurable or non-measurable) for response assessment. 7. Data Availability: availability of key clinical data (baseline characteristics, treatment history, and follow-up outcomes). Exclusion Criteria: 1. Lack of Exposure: Patients who never actually received iruplinalkib or took only a trivial amount (e.g., \< 1 week/cycle) before withdrawal for non-medical reasons. 2. Wrong Diagnosis: Active malignancy of other histological types (excluding treated basal cell carcinoma, etc.). 3. Confounding: Participation in another interventional clinical trial involving an investigational anti-tumor drug concurrently. 4. Pregnancy: Pregnant or breastfeeding women. 5. Data Quality: Missing critical medical records that preclude assessment of primary endpoints (e.g., unknown start date, unknown prior therapy).

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Conditions

The condition(s) this trial relates to.

lung adenocarcinoma non-small cell lung carcinoma

As listed by the trial registrant

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

ALK Iruplinalkib Lorlatinib Non-small cell lung cancer Observational study Real world study

How to take part

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

  1. The places running it

    1 site. 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

  • Peking University Shenzhen Hospital

    RECRUITING

    Shenzhen, Guangdong, 518000, China

More trials for these conditions

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