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Inhaled cancer drug tested in smokers – early study halted

NCT ID NCT06897735

Knowledge-focused Sponsor: Petrov, Andrey 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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-stage study tested whether inhaling the cancer drug afatinib works as well as taking it by mouth. Four healthy adult smokers received both forms in separate sessions to compare drug levels in the blood and lungs. The study was terminated early, so the findings are limited.

What this could mean

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

Active substance
Afatinib dimaleate (inhaled and oral forms)
What this could lead to
If successful, this could point toward a less toxic way to deliver afatinib directly to the lungs for treating lung cancer.
What could go wrong
This was a very early, small pilot study (only 4 participants) that was terminated, so results are limited. Inhaled delivery may not work as well as hoped, and side effects are still unknown.

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

4 people

The number who actually took part.

Started

Nov 2025

Finished

May 2026

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

21 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Healthy male and female volunteers aged 21 to 55 years * Body mass index (BMI) from 18.5 to 30.0 kg/m² * Smokers or people who use e-cigarettes or vapes * No history of serious lung disease or respiratory disorders * No history of EGFR-targeted therapy or chemotherapy * Ability to give informed consent and comply with study procedures Exclusion Criteria: * Pregnancy or lactation. (for female participants - 2 negative tests 10 days and 3 days before the start of the study) * Significant cardiovascular, hepatic, renal or neurological disorders. (ECG 30 days or earlier before the start of the study) * Recent use of any study drug (within 30 days) or prescription drugs that may affect the metabolism of afatinib * Known hypersensitivity to afatinib, its salts or derivatives of afatinib or related compounds * Рarticipation in other studies

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Conditions

The condition(s) this trial relates to.

lip and oral cavity carcinoma lung cancer lung neoplasm melanoma Mouth Neoplasms

As listed by the trial registrant

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

Lung cancer Melanoma Oral cancer

Contacts and locations

Locations

  • Central Contact

    Auckland, New Zealand

More trials for these conditions

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