Non Small Cell Lung CancerPhase 2NCT07661173
A Prospective Study of Firmonertinib as First-line Adaptive Therapy Guided by Dynamic ctDNA (MRD) Changes in Locally Advanced or Metastatic EGFR-mutated Non-small Cell Lung Cancer
A Phase 2 study testing Firmonertinib, Firmonertinib/pemetrexed/Carboplatin and Firmonertinib/pemetrexed/Carboplatin/Bevacizumab in people with Non Small Cell Lung Cancer, run by Anhui Provincial Cancer Hospital at 1 site in China.
Trial summary
Exploring the efficacy and safety of adaptively adjusting treatment regimens based on ctDNA (MRD) status for EGFR mutation-positive NSCLC Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Firmonertinib, Firmonertinib/pemetrexed/Carboplatin and Firmonertinib/pemetrexed/Carboplatin/Bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteChina
- Study dates
- 6 Jun 2026to 6 May 2031
- 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
- Sign a written informed consent before implementing any trial-related procedures;
- At least 18 years of age;
- Have histologically or cytologically confirmed non-squamous non-small cell lung cancer.
- Confirmed presence of EGFR-sensitive mutation-positive by tumor histology, cytology, hematology, or pleural effusion supernatant;
- ECOG score of 0-1;
- According to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), there must be at least one measurable lesion on imaging. Lesions located within the previous radiation field that have proven progression can be considered measurable;
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- Life expectancy >3 months at Day 1;
- Patients newly diagnosed with locally advanced (IIIB-IIIC), metastatic, or recurrent (stage IV) lung cancer according to the 9th edition of the TNM classification by the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer; not suitable for treatment with surgery or radiotherapy;
- Confirmed presence of EGFR mutation-positive by tumor histology, cytology, or hematology;
- Not previously treated with anti-angiogenic drugs/chemotherapy;
- Brain metastasis patients are allowed to be enrolled, as long as they meet the following conditions:
- Sufficient organ function, and the subjects must meet the following laboratory criteria:
- Absolute neutrophil count (ANC) ≥1.5x10^9/L without the use of granulocyte colony-stimulating factor in the past 14 days;
- Platelets ≥100×10^9/L without blood transfusion in the past 14 days;
- Hemoglobin >9g/dL without blood transfusion or erythropoietin use in the past 14 days;
- Total bilirubin ≤1.5×upper limit of normal (ULN);
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN (subjects with liver metastasis are allowed to have ALT or AST ≤5×ULN);
- Serum creatinine ≤1.5×ULN and creatinine clearance rate (calculated using the Cockcroft-Gault formula) ≥60 ml/min;
- Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN;
- Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. If the baseline TSH exceeds the normal range, subjects with total T3 (or FT3) and FT4 within the normal range may also be enrolled;
- myocardial enzyme profile within the normal range (subjects with simple laboratory abnormalities that the investigator comprehensively judges to have no clinical significance are also allowed to be enrolled);
- For female subjects of childbearing age, urine or serum pregnancy tests must be conducted within 3 days before the first dose of study drug (on Day 1 of Cycle 1) and the results must be negative. If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Non-childbearing age females are defined as those who have been postmenopausal for at least 1 year, or have undergone surgical sterilization or hysterectomy;
- If there is a risk of pregnancy, all subjects (regardless of gender) must use contraception with an annual failure rate of less than 1% throughout the treatment period until 120 days after the last dose of study drug (or 180 days after the last dose of study drug).
Who cannot join
- The pathology is small cell lung cancer (SCLC), including lung cancer with a mixture of SCLC and non-small cell lung cancer (NSCLC);
- The patient has received the following treatments:
- received systemic anti-tumor therapy within 3 weeks before treatment, such as chemotherapy, targeted therapy, immunotherapy (including Chinese herbal medicine therapy with anti-tumor indications), etc.;
- received any investigational drug therapy within 4 weeks before treatment;
- received high-dose immunosuppressive drugs (systemic glucocorticoids exceeding 10mg/day of prednisone or its equivalent dose) within 4 weeks before treatment;
- received attenuated live vaccines within 4 weeks before treatment (or plans to receive attenuated live vaccines during the study period);
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- underwent major surgery (such as thoracotomy, thoracotomy, or Kaifu surgery) within 4 weeks before treatment, or has unhealed surgical wounds, ulcers, or fractures.
- Subjects with clinically uncontrollable pleural/peritoneal effusion (not requiring drainage of effusion or showing no significant increase in effusion after 3 days of cessation of drainage) may be enrolled;
- Subjects with a history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonia requiring steroid treatment, or any evidence of clinically active ILD;
- Subjects who have received chest radiotherapy exceeding 30 Gy within 6 months prior to treatment or palliative radiotherapy of 30 Gy or less within 7 days prior to treatment (palliative radiotherapy for bone or intracranial lesions is allowed);
- Subjects who have experienced active autoimmune diseases requiring systemic treatment (such as the use of disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Alternative therapies (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered systemic treatment;
- Known allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
- Subjects who have not fully recovered from toxicity and/or complications caused by any intervention prior to the start of treatment (i.e., grade ≤1 or baseline, excluding fatigue or alopecia);
- Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive);
- Untreated active hepatitis B (defined as HBsAg positive with HBV-DNA copy number greater than the upper limit of normal in the laboratory department of the research center); Note: Subjects with hepatitis B who meet the following criteria may also be enrolled: 1) HBV viral load <1000 copies/ml (200 IU/ml) prior to the first dose, and subjects should receive anti-HBV treatment throughout the study drug treatment period to avoid viral reactivation; 2) For subjects with anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load (-), prophylactic anti-HBV treatment is not required, but close monitoring for viral reactivation is necessary.
- Subjects with active HCV infection (HCV antibody positive and HCV-RNA level above the detection limit);
- Subjects who have received a live vaccine within 30 days prior to the first dose (Cycle 1, Day 1); Note: Inactivated virus vaccine for seasonal influenza administered via injection is allowed within 30 days prior to the first dose; however, attenuated live influenza vaccine administered intranasally is not allowed.
- Pregnant or lactating women;
- Subjects with any severe or uncontrollable systemic diseases, such as:
- significant and symptomatically severe abnormalities in rhythm, conduction, or morphology on resting electrocardiogram, such as complete left bundle branch block, second-degree or higher heart block, ventricular arrhythmias, or atrial fibrillation;
- unstable angina, congestive heart failure, chronic heart failure with New York Heart Association (NYHA) classification of ≥ 2;
- myocardial infarction within 6 months prior to enrollment;
- poorly controlled blood pressure (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg);
- history of non-infectious pneumonia requiring glucocorticoid treatment within 1 year prior to the first dose, or current clinically active interstitial lung disease;
- active tuberculosis;
- active or uncontrollable infections requiring systemic treatment;
- clinically active diverticulitis, abdominal abscess, or gastrointestinal obstruction;
- liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;
- poorly controlled diabetes (fasting blood glucose (FBG) >10 mmol/L);
- urine routine test indicating proteinuria ≥++ and confirmed 24-hour urine protein quantitation >1.0 g;
- subjects with mental disorders and unable to cooperate with treatment; subjects with medical history or disease evidence, treatment, or laboratory test values that may interfere with trial results, hinder the subject's full participation in the study, or other situations deemed unsuitable for enrollment by the investigator; subjects deemed by the investigator to have other potential risks and are not suitable to participate in this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Anhui Provincial Cancer Hospital
Hefei, Anhui
Yueyin Pan, 13805695536, panyueyin@ustc.edu.cn
About this study
Exploring the efficacy and safety of adaptively adjusting treatment regimens based on ctDNA (MRD) status for EGFR mutation-positive NSCLC
Read the detailed description
For locally advanced or metastatic non-small cell lung cancer (NSCLC) patients carrying EGFR-sensitive mutations (Ex19del/L858R), we evaluated the clinical value of first-line adaptive treatment with firmonertinib guided by ctDNA EGFRm and minimal residual disease (MRD) status. Patients underwent gene testing either through tissue or blood samples (when tissue was not accessible). Patients with EGFR-sensitive mutations (Ex19del/L858R) also underwent Onco Snoar 172 gene testing. These patients were treated with firmonertinib monotherapy, and their clinical response was assessed through imaging after 6 weeks of treatment. Patients with primary resistance (PD) were excluded from the study, while other patients provided blood samples for gene testing. If patients' plasma did not harbor EGFR-sensitive mutations and did not exhibit other gene mutations, they continued to receive firmonertinib monotherapy. If other mutations were present, chemotherapy was added to firmonertinib. If patients had plasma EGFR-sensitive mutations, they were further grouped. Patients without ctDNA clearance and without gene mutations continued to receive oral firmonertinib, while those with other gene mutations received oral firmonertinib combined with chemotherapy. Patients with ctDNA clearance and PIK3CA, PTEN, RB1 mutations were treated with firmonertinib combined with chemotherapy. Patients with other gene mutations or no mutations received firmonertinib and chemotherapy combined with anti-angiogenic drugs. Patients with clearance and TP53 mutations received firmonertinib plus anti-angiogenic therapy. This study aimed to explore the efficacy of first-line adaptive treatment with firmonertinib guided by gene status in locally advanced or metastatic EGFR-mutant NSCLC.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Firmonertinib, Firmonertinib/pemetrexed/Carboplatin, Firmonertinib/pemetrexed/Carboplatin/Bevacizumab
- 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.
FirmonertinibDrug
80mg QD
Firmonertinib/pemetrexed/CarboplatinDrug
Drug: Firmonertinib daily and pemetrexed plus carboplatin on Day 1 of 21day cycles (every 3 weeks) for 4 cycles, followed by firmonertinib daily with pemetrexed maintenance every 3 weeks.
Firmonertinib/pemetrexed/Carboplatin/BevacizumabDrug
Drug: Firmonertinib daily and pemetrexed plus carboplatin on Day 1 of 21day cycles (every 3 weeks) for 4 cycles, followed by firmonertinib daily with pemetrexed and bevacizumab maintenance every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Arm A1 | Experimental | firmonertinib Receives: Drug: Firmonertinib |
| Arm A2 | Experimental | firmonertinib combined with chemotherapy Receives: Drug: Firmonertinib/pemetrexed/Carboplatin |
| Arm B1 | Experimental | firmonertinib combined with chemotherapy Receives: Drug: Firmonertinib/pemetrexed/Carboplatin |
| Arm B2 | Experimental | firmonertinib combined with chemotherapy and antiangiogenic drugs Receives: Drug: Firmonertinib/pemetrexed/Carboplatin/Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Measured: through study completion, an average of 2 years
Secondary outcomes (4)
Overall Survival (OS)
Measured: through study completion, an average of 4 years
Objective Response Rate (ORR)
Measured: through study completion, an average of 2 years
Disease Control Rate (DCR)
Measured: through study completion, up to 2 years
Duration of Response (DoR)
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start6 Jun 2026 (estimated)
- Primary completion6 Mar 2029 (estimated)
- Study completion6 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- 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
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yue-Yin Pan, Anhui Provincial Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07661173
- Sponsor's protocol ID
- 2026-LLYJ-0007
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Firmonertinib as First-line Adaptive Therapy Guided by Dynamic ctDNA (MRD) Changes in Locally Advanced or Metastatic EGFR-mutated Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07661173
- Acronym / sponsor ID
- 2026-LLYJ-0007
- Conditions
- Non Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Anhui Provincial Cancer HospitalUniversity, hospital or other
- Study start
- 6 Jun 2026 (estimated)
- Primary completion
- 6 Mar 2029 (estimated)
- Study completion
- 6 May 2031 (estimated)
- First posted
- 22 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.
Exploring the efficacy and safety of adaptively adjusting treatment regimens based on ctDNA (MRD) status for EGFR mutation-positive NSCLC
Detailed description
For locally advanced or metastatic non-small cell lung cancer (NSCLC) patients carrying EGFR-sensitive mutations (Ex19del/L858R), we evaluated the clinical value of first-line adaptive treatment with firmonertinib guided by ctDNA EGFRm and minimal residual disease (MRD) status. Patients underwent gene testing either through tissue or blood samples (when tissue was not accessible). Patients with EGFR-sensitive mutations (Ex19del/L858R) also underwent Onco Snoar 172 gene testing. These patients were treated with firmonertinib monotherapy, and their clinical response was assessed through imaging after 6 weeks of treatment. Patients with primary resistance (PD) were excluded from the study, while other patients provided blood samples for gene testing. If patients' plasma did not harbor EGFR-sensitive mutations and did not exhibit other gene mutations, they continued to receive firmonertinib monotherapy. If other mutations were present, chemotherapy was added to firmonertinib. If patients had plasma EGFR-sensitive mutations, they were further grouped. Patients without ctDNA clearance and without gene mutations continued to receive oral firmonertinib, while those with other gene mutations received oral firmonertinib combined with chemotherapy. Patients with ctDNA clearance and PIK3CA, PTEN, RB1 mutations were treated with firmonertinib combined with chemotherapy. Patients with other gene mutations or no mutations received firmonertinib and chemotherapy combined with anti-angiogenic drugs. Patients with clearance and TP53 mutations received firmonertinib plus anti-angiogenic therapy. This study aimed to explore the efficacy of first-line adaptive treatment with firmonertinib guided by gene status in locally advanced or metastatic EGFR-mutant NSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A1 | Experimental | Drug: Firmonertinibfirmonertinib |
| Arm A2 | Experimental | Drug: Firmonertinib/pemetrexed/Carboplatinfirmonertinib combined with chemotherapy |
| Arm B1 | Experimental | Drug: Firmonertinib/pemetrexed/Carboplatinfirmonertinib combined with chemotherapy |
| Arm B2 | Experimental | Drug: Firmonertinib/pemetrexed/Carboplatin/Bevacizumabfirmonertinib combined with chemotherapy and antiangiogenic drugs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Sign a written informed consent before implementing any trial-related procedures;
- At least 18 years of age;
- Have histologically or cytologically confirmed non-squamous non-small cell lung cancer.
- Confirmed presence of EGFR-sensitive mutation-positive by tumor histology, cytology, hematology, or pleural effusion supernatant;
- ECOG score of 0-1;
Key exclusion criteria (31 listed)
- The pathology is small cell lung cancer (SCLC), including lung cancer with a mixture of SCLC and non-small cell lung cancer (NSCLC);
- The patient has received the following treatments:
- Subjects with clinically uncontrollable pleural/peritoneal effusion (not requiring drainage of effusion or showing no significant increase in effusion after 3 days of cessation of drainage) may be enrolled;
- Subjects with a history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonia requiring steroid treatment, or any evidence of clinically active ILD;
- Subjects who have received chest radiotherapy exceeding 30 Gy within 6 months prior to treatment or palliative radiotherapy of 30 Gy or less within 7 days prior to treatment (palliative radiotherapy for bone or intracranial lesions is allowed);
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 |
|---|---|---|
| Firmonertinib80mg QD | Drug | Arm A1 |
| Firmonertinib/pemetrexed/CarboplatinDrug: Firmonertinib daily and pemetrexed plus carboplatin on Day 1 of 21day cycles (every 3 weeks) for 4 cycles, followed by firmonertinib daily with pemetrexed maintenance every 3 weeks. | Drug | Arm A2, Arm B1 |
| Firmonertinib/pemetrexed/Carboplatin/BevacizumabDrug: Firmonertinib daily and pemetrexed plus carboplatin on Day 1 of 21day cycles (every 3 weeks) for 4 cycles, followed by firmonertinib daily with pemetrexed and bevacizumab maintenance every 3 weeks. | Drug | Arm B2 |
Primary outcome
Progression-free survival (PFS)
Time frame: through study completion, an average of 2 years
4 secondary outcomes
Overall Survival (OS)
Time frame: through study completion, an average of 4 years
Objective Response Rate (ORR)
Time frame: through study completion, an average of 2 years
Disease Control Rate (DCR)
Time frame: through study completion, up to 2 years
Duration of Response (DoR)
Time frame: through study completion, an average of 2 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 22 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Firmonertinib, Firmonertinib/pemetrexed/Carboplatin and Firmonertinib/pemetrexed/Carboplatin/Bevacizumab in people with Non Small Cell Lung Cancer, run by Anhui Provincial Cancer Hospital at 1 site in China.
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 23 inclusion and 31 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 22 Jun 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 Yueyin Pan (13805695536, panyueyin@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: through study completion, an average of 2 years). 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 22 Jun 2026.