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Lung cancer drug alectinib put to the test in Dose-Finding trial

NCT ID NCT05713006

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 testing the drug alectinib in 45 Mexican patients with advanced ALK-positive non-small cell lung cancer. In the first phase, patients receive increasing doses every 21 days to measure drug levels and safety. In the second phase, the chosen dose is given to see how well it shrinks tumors. The goal is to find the best dose for this population.

What this could mean

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

Active substance
alectinib (Alecensa)
What this could lead to
If successful, this could help determine the optimal alectinib dose for ALK-positive lung cancer patients, potentially improving treatment outcomes.
What could go wrong
This is an early-phase trial with only 45 participants, so results may not apply to all patients. Dose escalation may cause side effects, and the drug may not shrink tumors as hoped.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 45 people

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

Started

May 2022

Expected to finish

Dec 2027

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.

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: * Both sexes * ≥ 18 years old * Pathologically confirmed diagnosis of NSCLC * Stage IIIB - IV by the American Joint Committee of Cancer Version 8. * Recurrent disease (at least 180 days from curative intent treatment) * ALK rearrangements tested by FDA-approved tests (IHQ or FISH) * Karnofsky PS scale ≥ 70% * Having received first-line treatment with anti-ALK inhibitors and one previous line of platinum-based chemotherapy. * Measurable disease as referred by RECIST version 1.1 * Symptomatic brain metastases could receive prior treatment with radiotherapy or surgery for at least two weeks before treatment initiation. * Asymptomatic brain metastases could not receive local therapy before study inclusion. * Negative highly sensitive pregnancy test (serum or urine) within 72 days before first dose intervention. * Sexually active patients should use a contraceptive method with a failure rate of less than 1% per year. * Signed written informed consent * Adequate organ function (hematological, liver, and renal function) * Life expectancy of at least 12 weeks Exclusion Criteria: * Carcinomatous meningitis confirmed by a positive CRL cytology or highly suspicious brain MRI. * Previous malignancies except for any carcinoma in-situ * Treatment with other anti-cancer therapy * Participating in other clinical trials in the former four weeks * Any other serious condition or uncontrolled active infection, altered mental status, or psychiatric condition that, in the investigator´s opinion, would limit the ability of an individual to meet the requirements of the study or which affects the interpretability of the results. * Active hepatitis virus infection (any serotype) or chronic infection with a potential risk of reactivation evaluated through a serological panel. * Active HIV infection. * Breastfeeding.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

  • Thoracic Oncology Unit and Personalized Medicine Laboratory, Instituto Nacional de Cancerología

    RECRUITING

    Mexico City, Mexico City, 14080, Mexico

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