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Double-Dose Firmonertinib in EGFR-Mutant Advanced NSCLC Achieving Stable Disease After Standard-Dose First-Line Firmonertinib

NCT ID: NCT07298148

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2032-12-31

Brief Summary

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This study evaluates the efficacy and safety of Firmonertinib 160 mg once daily in patients with EGFR-mutant, advanced NSCLC who achieve stable disease after first-line Firmonertinib 80 mg for 8 weeks.

Detailed Description

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Conditions

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NSCLC Stage IV EGFR Positive Non-small Cell Lung Cancer EGFR-TKI Sensitizing Mutation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Firmonertinib 160mg

Group Type EXPERIMENTAL

Firmonertinib 160mg

Intervention Type DRUG

Patients enter an 8-week induction phase at 80 mg once daily. Those with stable disease per RECIST v1.1 at Week 8 escalate to 160 mg daily until disease progression or unacceptable toxicity.

Interventions

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Firmonertinib 160mg

Patients enter an 8-week induction phase at 80 mg once daily. Those with stable disease per RECIST v1.1 at Week 8 escalate to 160 mg daily until disease progression or unacceptable toxicity.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Cancer Hospital & Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Sen Han, MD

Role: CONTACT

Phone: 010-88121122

Email: [email protected]

Other Identifiers

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2025YJZ88

Identifier Type: -

Identifier Source: org_study_id