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Can a dose increase control lung cancer that Isn't shrinking?

NCT ID NCT07298148

Disease control Sponsor: Peking University Cancer Hospital & Institute 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether a higher dose (160 mg) of the drug firmonertinib can improve outcomes for people with advanced EGFR-mutant non-small cell lung cancer whose tumors have stayed stable but not shrunk after 8 weeks on the standard 80 mg dose. About 28 adults aged 18-75 with no prior treatment will take the higher dose daily. The main goal is to see if more tumors shrink or disappear.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 28 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 2032

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 to 75 years

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 18-75 years. * ECOG performance status 0-1; life expectancy ≥3 months. * Histologically/cytologically confirmed advanced/metastatic non-squamous NSCLC unsuitable for curative therapy. * Documented EGFR 19del or L858R mutation. * No prior systemic therapy for advanced disease. * Stable disease after 8 weeks of Firmonertinib 80 mg daily. * more than 1 measurable lesion per RECIST v1.1. * Adequate hematologic, renal, hepatic, and coagulation function. * Signed written informed consent. Exclusion Criteria: * Hypersensitivity to Firmonertinib or related compounds. * Other actionable oncogenic drivers (ALK, ROS1, RET, BRAF, NTRK, MET, KRAS, except TP53/RB1). * Prior EGFR-TKI therapy or prohibited concomitant medications. * Unresolved toxicities \>CTCAE Grade 1 (except allowed conditions). * Symptomatic CNS metastases or spinal cord compression. * GI disorders impairing drug absorption. * Uncontrolled systemic diseases or active infections (HBV/HCV/HIV). * Interstitial lung disease (history or active). * Clinically significant cardiac abnormalities including QTc \>470 ms or LVEF \<50%. * Pregnancy or breastfeeding. * Any condition compromising compliance. * CR, PR, or PD at completion of induction therapy.

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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 positive non-small cell lung cancer EGFR-tki sensitizing mutation NSCLC stage IV

How to take part

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

  1. 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 ↗

  2. 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.

More trials for these conditions

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