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Firmonertinib 160 mg in Patients With EGFR-Mutant Advanced NSCLC Demonstrating SD After 8 Week Induction With Firmonertinib 80 mg

ConditionsNSCLC Stage IVEGFR Positive Non-small Cell Lung CancerEGFR-TKI Sensitizing Mutation
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPeking University Cancer Hospital & Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Single group

Treatments tested in this trial

  • Firmonertinib 160mg

    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.

Treatment groups

28 Participants
are divided into 1 treatment group
Group A: Firmonertinib 160mgExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR)

Percentage of patients achieving CR or PR per RECIST v1.1.

Time frame
From dose escalation (Week 8) until documented disease progression or start of new anticancer therapy, assessed approximately every 8 weeks, up to 24 months.

Secondary outcomes

1

Progression-Free Survival (PFS)

Time from the start of randomization (or the start of treatment in a single-arm trial) to tumor progression or death from any cause, whichever occurs first.

Time frame
From first dose to disease progression or death, whichever occurs first; followed for up to 24 months.
2

Disease Control Rate (DCR)

Percentage of patients achieving CR, PR, or SD.per RECIST v1.1.

Time frame
From dose escalation (Week 8) until documented disease progression or start of new anticancer therapy, assessed approximately every 8 weeks, up to 24 months.
3

Duration of Response (DoR)

Duration from first response to progression or death.

Time frame
From dose escalation (Week 8) until documented disease progression or start of new anticancer therapy, assessed approximately every 8 weeks, up to 24 months.
4

CNS Objective Response Rate (CNS-ORR)

Evaluated via CNS imaging per RECIST v1.1 or applicable CNS criteria.

Time frame
From dose escalation (Week 8) until documented disease progression or start of new anticancer therapy, assessed approximately every 8 weeks, up to 24 months.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University Cancer Hospital & Institute

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: