NSCLCPhase 2NCT07622706

Firmonertinib in Perioperative Treatment of Resectable Stage II-IIIB EGFR-mutated Lung Adenocarcinoma

A Phase 2 study testing Firmonertinib 80mg qd oral for 8 weeks., Firmonertinib 160mg qd oral for 8 weeks. and Firmonertinib 80mg qd oral for 16 weeks. in people with NSCLC and EGFR Positive Non-small Cell Lung Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

An Open-label, Single-arm, Phase II Clinical Study of Firmonertinib in Perioperative Treatment of Resectable Stage II-IIIB EGFR-mutated Lung Adenocarcinoma. The goal of this study was to evaluate the efficacy of firmonertinib neoadjuvant in patients with resectable stage II-IIIB EGFR-mutated non-small cell lung cancer… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: NSCLC, EGFR Positive Non-small Cell Lung Cancer, Neoadjuvant Therapy
What is being tested?: Firmonertinib 80mg qd oral for 8 weeks., Firmonertinib 160mg qd oral for 8 weeks. and Firmonertinib 80mg qd oral for 16 weeks.
Type of treatment: Pill or oral medicine, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteChina
Study dates: 3 Sep 2026to 30 Dec 2029
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

1.Prior to the initiation of any study-related procedures, including examinations, sample collection, or analyses, written informed consent was obtained from all participating patients.
2.Male or female, aged >=18 years;
3.Histologically or cytologically confirmed primary lung adenocarcinoma within 60 days prior to study entry.
4.Stage II-IIIB disease (AJCC 9th edition) confirmed by systematic imaging (contrast-enhanced chest/abdominal CT, brain CT/MRI, bone scan, or PET/CT), with lesions eligible for radical resection.
5.EGFR mutation-positive (19Del and/or L858R, with or without T790M) as determined by NGS testing of tumor tissue or blood.
6.At least one measurable lesion with a longest diameter >=10 mm on baseline CT scan (except lymph nodes, which must have a short-axis diameter >=15 mm), and suitable for accurate and repeated measurement.

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7.ECOG performance status 0-1.
8. Female patients should take adequate and effective contraception, must not breastfeed, and have a negative pregnancy test before the first administration of the study drug; or female patients must meet the following criteria at screening to demonstrate infertility: (1) Postmenopausal, defined as older than 50 years of age and having no menstruation for at least 12 months after stopping all exogenous hormone therapy. (2) For women under 50 years old, if there is no menstruation for 12 months or longer after stopping exogenous hormone therapy, and luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels are in the postmenopausal range, they are considered postmenopausal. (3) Documented irreversible sterilization surgery, including hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, excluding tubal ligation.
9. Male patients should be willing to use barrier contraception, i.e., condoms.

Who cannot join

1.Tumors with squamous cell carcinoma, large cell carcinoma, or neuroendocrine components such as small cell carcinoma.
2.Presence of EGFR exon 20 insertion mutation detected by genetic testing.
3.Prior exposure to other antitumor therapies before enrollment.
4.Major surgery within 4 weeks prior to the first dose of study drug (including surgery for the primary tumor, excluding procedures for vascular access).
5.Scheduled or planned medical procedures (e.g., endoscopy or biopsy) or surgical operations within the next 4 months.
6.The patient is pregnant or breastfeeding.

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7.Use of strong CYP3A4 inhibitors within 7 days, or strong CYP3A4 inducers within 21 days prior to the first dose of study drug; use of traditional Chinese medicines or herbal preparations indicated for antitumor treatment, those with tumor adjuvant effects, or any other agents with known antitumor activity within 14 days prior to the first dose.
8.History of other malignancies or concurrent malignancies, except for those that have been definitively treated with curative intent and with no evidence of recurrence for at least 5 years (e.g., carcinoma in situ of the cervix, basal cell carcinoma of the skin, or papillary thyroid carcinoma).
9.Patients with severe or uncontrolled systemic diseases requiring treatment, deemed unsuitable for participation by the investigator. These include but are not limited to: uncontrolled hypertension, diabetes, chronic heart failure (NYHA class III-IV), unstable angina, myocardial infarction within the past year, active bleeding disorders; hepatitis B (including all HBsAg-positive patients), hepatitis C (HCV antibody positive), or human immunodeficiency virus (HIV) infection; as well as patients with active infections requiring intravenous treatment.
10.Patients with severe gastrointestinal dysfunction or clinical conditions that may affect the intake, transport, or absorption of the study drug, such as inability to take oral medication, uncontrolled nausea and vomiting, or a history of extensive gastrointestinal resection.
11. Meets any of the following cardiac assessment criteria: (1) Resting ECG corrected QT interval (QTc) >470 msec, with QTc corrected using the Fridericia formula (if the initial ECG shows QTc >470 ms, repeat the ECG twice and take the average of the three QTc results). (2) Any clinically significant abnormalities in heart rhythm, conduction, or morphology on resting ECG, such as complete left bundle branch block, second-degree or third-degree atrioventricular block, etc. (3) Any factors that increase the risk of QTc prolongation or arrhythmia events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, sudden unexplained death in first-degree relatives under 40 years old, or taking any concomitant medication known to prolong the QT interval that cannot be discontinued.
12. History of interstitial lung disease (ILD), drug-induced interstitial lung disease, radiation pneumonitis requiring glucocorticoid treatment, or patients with clinical manifestations suspected to be interstitial lung disease.
13. Any of the following laboratory test results indicating insufficient bone marrow or organ reserve function: (1) Absolute neutrophil count <1.5×10^9/L; (2) Platelet count <100×10^9/L; (3) Hemoglobin <90 g/L; (4) Alanine aminotransferase (ALT) >2.5× upper limit of normal (ULN); (5) Aspartate aminotransferase (AST) >2.5×ULN; (6) Total bilirubin >1.5×ULN or, in the case of Gilbert's syndrome (unconjugated hyperbilirubinemia), >3×ULN; (7) Creatinine clearance <50 mL/min (calculated by the Cockcroft-Gault formula); (8) Prothrombin time (PT), international normalized ratio (INR), activated partial thromboplastin time (aPTT) >=1.5 times ULN;
14. Known or suspected allergy to pralsetinib or any other component of its formulation;
15. Other situations where the patient is unable to comply with study procedures, restrictions, or requirements, and the investigator considers that such patient should not or is unsuitable to participate in the study;
16. Patients currently or previously participating in any other anti-tumor clinical study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jia Wang, proffessor contact

86-10-88196391

gcp_yuanyn@bjcancer.org

China1 site, 1 recruiting

Peking University Cancer Hospital & Institute
Beijing, 100142
Jia Wang, 86-10-88196391, gcp_yuanyn@bjcancer.org
Recruiting

Other trials in China

About this study

Official title: An Open-label, Single-arm, Phase II Clinical Study of Firmonertinib in Perioperative Treatment of Resectable Stage II-IIIB EGFR-mutated Lung Adenocarcinoma

An Open-label, Single-arm, Phase II Clinical Study of Firmonertinib in Perioperative Treatment of Resectable Stage II-IIIB EGFR-mutated Lung Adenocarcinoma.

The goal of this study was to evaluate the efficacy of firmonertinib neoadjuvant in patients with resectable stage II-IIIB EGFR-mutated non-small cell lung cancer (NSCLC) by major pathologic response (MPR).

Conditions: NSCLC, EGFR Positive Non-small Cell Lung Cancer, Neoadjuvant Therapy
Being tested: Firmonertinib 80mg qd oral for 8 weeks., Firmonertinib 160mg qd oral for 8 weeks., Firmonertinib 80mg qd oral for 16 weeks., Radical resection, firmonertinib adjuvant therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Firmonertinib 80mg qd oral for 8 weeks.Drug
Also called AST-2818
Participations will receive the drug treatments preoperatively: Firmonertinib 80mg qd oral for 8 weeks. Radical tumor resection will be completed 3-4 weeks after the end of drug treatment.
Firmonertinib 160mg qd oral for 8 weeks.Drug
Also called AST-2818
Participations will receive the drug treatments preoperatively: Firmonertinib 160mg qd oral for 8 weeks. Radical tumor resection will be completed 3-4 weeks after the end of drug treatment.
Firmonertinib 80mg qd oral for 16 weeks.Drug
Also called AST-2818
Participations will receive the drug treatments preoperatively: Firmonertinib 80mg qd oral for 16 weeks. Radical tumor resection will be completed 3-4 weeks after the end of drug treatment.
Radical resectionProcedure or surgery
Radical resection of the tumor will be performed within 3-4 weeks after the end of treatment.
firmonertinib adjuvant therapyDrug
Also called AST-2818
After surgery, participations will receive the drug treatments preoperatively: Firmonertinib 80mg qd oral as adjuvant therapy for 3 years. The investigator may decide whether to add chemotherapy or to change other adjuvant treatment modalities.

Study groups in NCT07622706
Study group	Role	What they receive
Group A	Experimental	Participations will receive the drug treatments preoperatively. Radical tumor resection will be completed 3-4 weeks after the end of drug treatment. Receives: Drug: Firmonertinib 80mg qd oral for 8 weeks.; Procedure: Radical resection; Drug: firmonertinib adjuvant therapy
Group B	Experimental	Participations will receive the drug treatments preoperatively. Radical tumor resection will be completed 3-4 weeks after the end of drug treatment. Receives: Drug: Firmonertinib 160mg qd oral for 8 weeks.; Procedure: Radical resection; Drug: firmonertinib adjuvant therapy
Group C	Experimental	Participations will receive the drug treatments preoperatively. Radical tumor resection will be completed 3-4 weeks after the end of drug treatment. Receives: Drug: Firmonertinib 80mg qd oral for 16 weeks.; Procedure: Radical resection; Drug: firmonertinib adjuvant therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Major Pathological Response (MPR) Rate
Defined as the time from the date of surgery to the first occurrence of local or distant disease recurrence, or death from any cause.
Measured: At the time of surgery (approximately Week 12 from treatment initiation for Cohort 1 and Cohort 2, and Week 20 for Cohort 3), Assessed up to 3 years

Secondary outcomes (8)

Objective Response Rate (ORR)
The percentage of patients who achieve a Complete Response (CR) or Partial Response (PR) based on radiological evaluation (e.g., RECIST v1.1).
Measured: From baseline up to the pre-operative tumor assessment (at Week 8 for Cohort 1 and Cohort 2, and at Week 16 for Cohort 3). Assessed up to 3 years
Disease Control Rate (DCR)
The percentage of patients who achieve CR, PR, or Stable Disease (SD) based on radiological evaluation (e.g., RECIST v1.1).
Measured: From baseline up to the pre-operative tumor assessment (at Week 8 for Cohort 1 and Cohort 2, and at Week 16 for Cohort 3). Assessed up to 3 years
Pathological Complete Response (pCR) Rate
The proportion of patients with no remaining viable tumor cells (ypT0N0) in the resected primary tumor and sampled lymph nodes
Measured: From baseline up to the pre-operative tumor assessment (at Week 8 for Cohort 1 and Cohort 2, and at Week 16 for Cohort 3). Assessed up to 3 years
R0 Resection Rate
The percentage of patients who achieve radical tumor resection with microscopically negative margins (R0 resection) as confirmed by histopathological analysis.
Measured: At the time of surgery (approximately Week 12 from treatment initiation for Cohort 1 and Cohort 2, and Week 20 for Cohort 3) compared to baseline clinical staging. Assessed up to 3 years
Pathological Lymph Node Downstaging Rate
The proportion of patients who exhibit a reduction in pathological lymph node stage compared to their pre-treatment clinical staging
Measured: From baseline up to the pre-operative tumor assessment (at Week 8 for Cohort 1 and Cohort 2, and at Week 16 for Cohort 3). Assessed up to 3 years
Disease-Free Survival (DFS)
Defined as the time from the date of surgery to the first occurrence of local or distant disease recurrence, or death from any cause.
Measured: From the date of radical surgery up to the date of first documented disease recurrence or death from any cause, assessed up to 3.5 years
Incidence and Severity of Adverse Events (AEs)
The frequency, severity, and types of adverse events, graded and classified according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: From the first dose of study drug until 28 days after the last dose of study drug, and throughout the perioperative/adjuvant treatment period assessed up to 3.5 years
Incidence of Surgical Complications
The percentage and specific types of surgery-related complications reported in the perioperative phase.
Measured: Within 30 days following the surgical procedure assessed up to 3.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Sep 202630 Dec 2029

First posted3 Jun 2026
Study start3 Sep 2026
Primary completion30 Dec 2029 (estimated)
Study completion30 Dec 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for NSCLCStudies 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07622706
Sponsor's protocol ID: 2026YJZ05
Other IDs: ChiCTR2600123002
Status last verified: Sep 2026
First submitted: 28 May 2026
Last updated: 27 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Single-arm, Phase II Clinical Study of Firmonertinib in Perioperative Treatment of Resectable Stage II-IIIB EGFR-mutated Lung Adenocarcinoma
ClinicalTrials.gov ID: NCT07622706
Acronym / sponsor ID: 2026YJZ05
Conditions: NSCLC, EGFR Positive Non-small Cell Lung Cancer, Neoadjuvant Therapy
Phase: Phase 2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 60 participants (estimated)
Lead sponsor: Peking University Cancer Hospital & InstituteUniversity, hospital or other
Study start: 3 Sep 2026 (actual)
Primary completion: 30 Dec 2029 (estimated)
Study completion: 30 Dec 2029 (estimated)
First posted: 3 Jun 2026 (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.

An Open-label, Single-arm, Phase II Clinical Study of Firmonertinib in Perioperative Treatment of Resectable Stage II-IIIB EGFR-mutated Lung Adenocarcinoma.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Group A	Experimental	Drug: Firmonertinib 80mg qd oral for 8 weeks., Procedure: Radical resection, Drug: firmonertinib adjuvant therapyParticipations will receive the drug treatments preoperatively. Radical tumor resection will be completed 3-4 weeks after the end of drug treatment.
Group B	Experimental	Drug: Firmonertinib 160mg qd oral for 8 weeks., Procedure: Radical resection, Drug: firmonertinib adjuvant therapyParticipations will receive the drug treatments preoperatively. Radical tumor resection will be completed 3-4 weeks after the end of drug treatment.
Group C	Experimental	Drug: Firmonertinib 80mg qd oral for 16 weeks., Procedure: Radical resection, Drug: firmonertinib adjuvant therapyParticipations will receive the drug treatments preoperatively. Radical tumor resection will be completed 3-4 weeks after the end of drug treatment.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

1.Prior to the initiation of any study-related procedures, including examinations, sample collection, or analyses, written informed consent was obtained from all participating patients.
2.Male or female, aged >=18 years;
3.Histologically or cytologically confirmed primary lung adenocarcinoma within 60 days prior to study entry.
4.Stage II-IIIB disease (AJCC 9th edition) confirmed by systematic imaging (contrast-enhanced chest/abdominal CT, brain CT/MRI, bone scan, or PET/CT), with lesions eligible for radical resection.
5.EGFR mutation-positive (19Del and/or L858R, with or without T790M) as determined by NGS testing of tumor tissue or blood.

Key exclusion criteria (16 listed)

1.Tumors with squamous cell carcinoma, large cell carcinoma, or neuroendocrine components such as small cell carcinoma.
2.Presence of EGFR exon 20 insertion mutation detected by genetic testing.
3.Prior exposure to other antitumor therapies before enrollment.
4.Major surgery within 4 weeks prior to the first dose of study drug (including surgery for the primary tumor, excluding procedures for vascular access).
5.Scheduled or planned medical procedures (e.g., endoscopy or biopsy) or surgical operations within the next 4 months.

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 80mg qd oral for 8 weeks.Also: AST-2818Participations will receive the drug treatments preoperatively: Firmonertinib 80mg qd oral for 8 weeks. Radical tumor resection will be completed 3-4 weeks after the end of drug treatment.	Drug	Group A
Firmonertinib 160mg qd oral for 8 weeks.Also: AST-2818Participations will receive the drug treatments preoperatively: Firmonertinib 160mg qd oral for 8 weeks. Radical tumor resection will be completed 3-4 weeks after the end of drug treatment.	Drug	Group B
Firmonertinib 80mg qd oral for 16 weeks.Also: AST-2818Participations will receive the drug treatments preoperatively: Firmonertinib 80mg qd oral for 16 weeks. Radical tumor resection will be completed 3-4 weeks after the end of drug treatment.	Drug	Group C
Radical resectionRadical resection of the tumor will be performed within 3-4 weeks after the end of treatment.	Procedure or surgery	Group A, Group B, Group C
firmonertinib adjuvant therapyAlso: AST-2818After surgery, participations will receive the drug treatments preoperatively: Firmonertinib 80mg qd oral as adjuvant therapy for 3 years. The investigator may decide whether to add chemotherapy or to change other adjuvant treatment modalities.	Drug	Group A, Group B, Group C

Primary outcome

Major Pathological Response (MPR) Rate
Time frame: At the time of surgery (approximately Week 12 from treatment initiation for Cohort 1 and Cohort 2, and Week 20 for Cohort 3), Assessed up to 3 years
Defined as the time from the date of surgery to the first occurrence of local or distant disease recurrence, or death from any cause.

8 secondary outcomes

Objective Response Rate (ORR)
Time frame: From baseline up to the pre-operative tumor assessment (at Week 8 for Cohort 1 and Cohort 2, and at Week 16 for Cohort 3). Assessed up to 3 years
Disease Control Rate (DCR)
Time frame: From baseline up to the pre-operative tumor assessment (at Week 8 for Cohort 1 and Cohort 2, and at Week 16 for Cohort 3). Assessed up to 3 years
Pathological Complete Response (pCR) Rate
Time frame: From baseline up to the pre-operative tumor assessment (at Week 8 for Cohort 1 and Cohort 2, and at Week 16 for Cohort 3). Assessed up to 3 years
R0 Resection Rate
Time frame: At the time of surgery (approximately Week 12 from treatment initiation for Cohort 1 and Cohort 2, and Week 20 for Cohort 3) compared to baseline clinical staging. Assessed up to 3 years
Pathological Lymph Node Downstaging Rate
Time frame: From baseline up to the pre-operative tumor assessment (at Week 8 for Cohort 1 and Cohort 2, and at Week 16 for Cohort 3). Assessed up to 3 years
Disease-Free Survival (DFS)
Time frame: From the date of radical surgery up to the date of first documented disease recurrence or death from any cause, assessed up to 3.5 years
Incidence and Severity of Adverse Events (AEs)
Time frame: From the first dose of study drug until 28 days after the last dose of study drug, and throughout the perioperative/adjuvant treatment period assessed up to 3.5 years
Incidence of Surgical Complications
Time frame: Within 30 days following the surgical procedure assessed up to 3.5 years

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 27 Oct 2026.

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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.

Jia Wang, proffessor contact

86-10-88196391

gcp_yuanyn@bjcancer.org

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 16 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: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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 Jia Wang, proffessor (86-10-88196391, gcp_yuanyn@bjcancer.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major Pathological Response (MPR) Rate (time frame: At the time of surgery (approximately Week 12 from treatment initiation for Cohort 1 and Cohort 2, and Week 20 for Cohort 3), Assessed up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07622706.

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 27 Oct 2026.