NSCLC Stage IVPhase 2NCT07298148
Firmonertinib 160 mg in Patients With EGFR-Mutant Advanced NSCLC Demonstrating SD After 8 Week Induction With Firmonertinib 80 mg
A Phase 2 study testing Firmonertinib 160mg in people with NSCLC Stage IV and EGFR Positive Non-small Cell Lung Cancer, run by Peking University Cancer Hospital & Institute.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC Stage IV, EGFR Positive Non-small Cell Lung Cancer, EGFR-TKI Sensitizing Mutation
- What is being tested?
- Firmonertinib 160mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 31 Dec 2032
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- more than 1 measurable lesion per RECIST v1.1.
- Adequate hematologic, renal, hepatic, and coagulation function.
- Signed written informed consent.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Prospective, Phase II, Single-Arm Study of Firmonertinib 160 mg in Patients With EGFR-Mutant Advanced NSCLC Demonstrating Stable Disease After 8 Week Induction With Firmonertinib 80 mg
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.
- Being tested
- Firmonertinib 160mg
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Firmonertinib 160mgDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Firmonertinib 160mg | Experimental | Not described Receives: Drug: Firmonertinib 160mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Percentage of patients achieving CR or PR per RECIST v1.1.
Measured: 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 (5)
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.
Measured: From first dose to disease progression or death, whichever occurs first; followed for up to 24 months.
Disease Control Rate (DCR)
Percentage of patients achieving CR, PR, or SD.per RECIST v1.1.
Measured: From dose escalation (Week 8) until documented disease progression or start of new anticancer therapy, assessed approximately every 8 weeks, up to 24 months.
Duration of Response (DoR)
Duration from first response to progression or death.
Measured: From dose escalation (Week 8) until documented disease progression or start of new anticancer therapy, assessed approximately every 8 weeks, up to 24 months.
CNS Objective Response Rate (CNS-ORR)
Evaluated via CNS imaging per RECIST v1.1 or applicable CNS criteria.
Measured: From dose escalation (Week 8) until documented disease progression or start of new anticancer therapy, assessed approximately every 8 weeks, up to 24 months.
Incidence of Treatment-related adverse event (TRAE)
any adverse event that in the investigator's opinion may have been caused by the study medication with reasonable possibility per CTCAE 5.0.
Measured: From first dose of therapy through 30 days after last dose of study treatment up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC Stage IVStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07298148
- Sponsor's protocol ID
- 2025YJZ88
- Status last verified
- Jan 2026
- First submitted
- 11 Dec 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Phase II, Single-Arm Study of Firmonertinib 160 mg in Patients With EGFR-Mutant Advanced NSCLC Demonstrating Stable Disease After 8 Week Induction With Firmonertinib 80 mg
- ClinicalTrials.gov ID
- NCT07298148
- Acronym / sponsor ID
- 2025YJZ88
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Firmonertinib 160mg | Experimental | Drug: Firmonertinib 160mg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Firmonertinib 160mgPatients 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. | Drug | Firmonertinib 160mg |
Primary outcome
Objective Response Rate (ORR)
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.
Percentage of patients achieving CR or PR per RECIST v1.1.
5 secondary outcomes
Progression-Free Survival (PFS)
Time frame: From first dose to disease progression or death, whichever occurs first; followed for up to 24 months.
Disease Control Rate (DCR)
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.
Duration of Response (DoR)
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.
CNS Objective Response Rate (CNS-ORR)
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.
Incidence of Treatment-related adverse event (TRAE)
Time frame: From first dose of therapy through 30 days after last dose of study treatment up to 24 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Firmonertinib 160mg in people with NSCLC Stage IV and EGFR Positive Non-small Cell Lung Cancer, run by Peking University Cancer Hospital & Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sen Han, MD (010-88121122, handsomehansen1@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.