Non-Small Cell Lung CancerPhase 2NCT06652048
High-dose Furmonertinib or Combined With Chemotherapy in EGFR-mutant Advanced NSCLC After Disease Progression on Third-generation EGFR-TKI
A Phase 2 study testing Furmonertinib 160mg QD, Furmonertinib 240mg QD and Furmonertinib 160mg QD plus Chemotherapy in people with Non-Small Cell Lung Cancer, run by Jialei Wang at 1 site in China.
Trial summary
This is a multicenter, open-label,randomised phase II study planned to include 60 subjects with EGFR-sensitive mutation advanced NSCLC after disease progression on first-line treatment with third-generation EGFR-TKI.Eligible patients will randomly be assigned in a 1:1:1 ratio to receive 160mg/240mg furmonertinib p.o… 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?
- Furmonertinib 160mg QD, Furmonertinib 240mg QD and Furmonertinib 160mg QD plus Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to Dec 2027
- 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
- Locally advanced or metastatic non-small cell lung cancer ;
- Histologically or haematologically confirmed EGFR-sensitive mutations;
- Developed radiological progression after first-line third-generation EGFR-TKI monotherapy without any other subsequent systemic therapy. Patients received Osimertinib or Almonertinib for at least 3 months prior to progression and were discontinued 8 days prior to randomization, patients received Furmonertinib prior to progression achieved remission or sustained clinical benefit for at least 6 months (progression occurred during or \<6 months after the last dose when the third-generation EGFR-TKI as a neoadjuvant/adjuvant , EGFR-TKI is considered as first-line treatment); Patients who had previously received chemotherapy or immunotherapy as neoadjuvant or adjuvant therapy could be included if they had metastatic/recurrent disease diagnosed more than 6 months after the last treatment and had radiographic progression after third-generation EGFR-TKI therapy;
- Patient has at least one accurately measurable lesion that has not been previously irradiated or biopsied during the screening period, according to RECIST 1.1; If the patient has one and only one measurable lesion, tissue biopsy of the lesion is permitted if the investigator assesses has limited impact on lesion detection, but baseline imaging of the lesion should be performed after tissue biopsy;
- Age ≥18 years old;
- ECOG 0-1 and had not worsened 2 weeks prior to enrollment;
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- Life expectancy ≥ 12 weeks;
- Female patients of reproductive age must have a blood pregnancy test within 7 days before the first medication and it is negative; Infertile women can avoid pregnancy tests and contraception.;
- Able to comply with study protocols;
- Patient himself voluntarily participated and signed the informed consent.
Who cannot join
- The tumor is confirmed by histology or cytology to be complicated with small cell lung cancer, neuroendocrine carcinoma, carcinosarcoma component or squamous cell carcinoma component exceeding 10%;
- There are other driver gene mutations with known drug therapy (such as MET amplification, RET fusion, BRAF V600E mutation, etc.);
- Allergy to the study drug and/or its excipients is known or suspected;
- Treatment with any of the following:
- Received any systemic anti-tumor therapy other than third-generation EGFR-TKI (including anti-tumor drugs in clinical research) before the first dose, and received cytotoxic drugs with significant delayed toxicity, such as mitomycin C and nitrosoureas, within 6 weeks before the first dose;
- Received non-specific immunomodulators (including but not limited to interferon, IL-2), Chinese medicine or Chinese medicine preparations approved for anti-tumor indications within 2 weeks prior to initial administration;
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- Received a potent inhibitor of cytochrome P450 3A4 enzyme (CYP3A4) or a potent inducer within 7 days prior to the initial study drug administration, or who require continued treatment with these drugs during the study period;
- Chest radiation therapy \> 30 Gy within 6 months prior to initial dosing; Non-thoracic (except central nervous system) radiation therapy of \>30 Gy within 4 weeks prior to initial dosing; Receiving palliative radiotherapy ≤30Gy within 2 weeks before the first dose;
- Received intrapleural perfusion were not admitted until 28 days or more after the pleural fluid had stabilized;
- Major surgery within 28 days of the first dose of study drug;
- Patients with any factors that increase the risk of QTc prolongation or risk of Torsade ventricular tachycardia event who continuously take these medications during investigating period;
- The toxicity associated with previous antitumor therapy did not return to ≤CTCAE Class 1, except for hair loss or chemotherapy-induced ≤CTCAE class 2 peripheral neurotoxicity;
- There is spinal cord compression or symptomatic central nervous system (CNS) metastasis; Patients who were asymptomatic, stable, and did not require steroid treatment for 14 days or more before the first study drug administration were excluded. Patients who had received local CNS metastasis radiotherapy could only be enrolled after the end of radiotherapy and CNS metastasis symptoms were stable for 14 days or more;
- Have other malignant tumors within the last 5 years or have a history of other malignant tumors, except skin basal cell carcinoma, cervical carcinoma in situ and breast ductal carcinoma in situ, which have been effectively controlled for more than 3 years;
- Recent active peptic diseases, such as duodenal ulcer, ulcerative colitis, ileitis, etc., intestinal perforation, intestinal fistula, or other conditions that may lead to gastrointestinal bleeding or perforation as prescribed by the investigator; Refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow study drugs, or prior major intestinal resection, which as determined by the investigator;
- Evidence of any severe or uncontrolled systemic disease, including uncontrolled hypertension, diabetes, and active bleeding, hepatitis B (Hepatitis B surface antigen (HBsAg) positive and HBV-DNA≥500 Active infections including IU/mL or higher than the lower limit of detection）, hepatitis C (positive for hepatitis C antibodies and HCV-RNA above the lower limit of detection), and human immunodeficiency virus (HIV) (including any patient receiving intravenous treatment for infection);
- Past or current interstitial lung disease (ILD) or suspected ILD that could not be ruled out by imaging examination during screening;
- Pulmonary complications resulting in clinically severe lung damage include, but are not limited to the following: Any serious underlying lung disease (e.g., pulmonary embolism diagnosed within 3 months prior to first dosing, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, etc.) b. Any autoimmune, connective tissue, or inflammatory diseases that may involve the lungs (such as rheumatoid arthritis, Sjogren\'s syndrome, and sarcoidosis), and other conditions that the investigator determines may increase the risk of developing interstitial pneumonia;
- Any evidence of known corneal injury;
- Examination within 28 days prior to administration of the first investigational drug revealed a lack of adequate bone marrow reserve or organ function；
- Any condition meets the following cardiac standard:
- Mean resting corrected QT interval (QTc)\>470 msec, obtained from 3 ECG, using the screening clinic ECG machine-derived QTc value.
- Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG, e.g., complete left bundle branch block, third-degree heart block, second-degree heart block；
- Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval.
- Echocardiographic examination: LVEF\<50%，history of myocardial infarction, severe or unstable angina pectoris, coronary artery bypass surgery, or cardiac insufficiency ≥ NYHA Level 2 within the last 6 months；
- Patients determined by the investigator to be unable to participate in the study, such as patients with a high probability of failing to comply with the study regulations, constraints, and requirements; Or other circumstances at the discretion of the investigator;
- Pregnancy or breastfeeding.
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, 1 recruiting
- Recruiting
Fudan university shanghai cancer center
Shanghai, Shanghai Municipality, 021
Jialei Pro. Wang, 021-64175590, luwangjialei@126.com
About this study
Official title: High-dose Furmonertinib or Combined With Pemetrexed and Carboplatin/Cisplatin in EGFR-sensitive Mutation Advanced NSCLC After Disease Progression on First-line Treatment of Third-generation EGFR-TKI:a Multicencer,Open-label,Randomized Phase II Study
This is a multicenter, open-label,randomised phase II study planned to include 60 subjects with EGFR-sensitive mutation advanced NSCLC after disease progression on first-line treatment with third-generation EGFR-TKI.Eligible patients will randomly be assigned in a 1:1:1 ratio to receive 160mg/240mg furmonertinib p.o qd or 160mg furmonertinib p.o qd plus chemotherapy[(carboplatin AUC 5 / cisplatin 75mg/m2+ pemetrexed 500mg/m2) every 21 days ×4 cycles + pemetrexed 500mg/m2 every 21 days maintenance].Patients will be followed up every 2 cycles during the first half year , and every 3 cycles after the first half year.Treatment was continued until disease progression,intolerable toxic effects, investigator decision, patient withdrawal of consent, or death, whichever occurred first.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Furmonertinib 160mg QD, Furmonertinib 240mg QD, Furmonertinib 160mg QD plus Chemotherapy
- 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.
Furmonertinib 160mg QDDrug
All patients enrolled into this group will receive furmonertinib 160mg p.o qd.
Furmonertinib 240mg QDDrug
All patients enrolled into this group will receive furmonertinib 240mg p.o qd.
Furmonertinib 160mg QD plus ChemotherapyDrug
All patients enrolled into this group will receive furmonertinib 160mg furmonertinib p.o qd plus chemotherapy[(carboplatin AUC 5 / cisplatin 75mg/m2+ pemetrexed 500mg/m2) every 21 days ×4 cycles + pemetrexed 500mg/m2 every 21 days maintenance]
| Study group | Role | What they receive |
|---|---|---|
| Furmonertinib 160mg QD | Experimental | All patients enrolled into this group will receive furmonertinib 160mg p.o qd. Receives: Drug: Furmonertinib 160mg QD |
| Furmonertinib 240mg QD | Experimental | All patients enrolled into this group will receive furmonertinib 240mg p.o qd. Receives: Drug: Furmonertinib 240mg QD |
| Furmonertinib 160mg QD plus Chemotherapy | Experimental | All patients enrolled into this group will receive furmonertinib 160mg furmonertinib p.o qd plus chemotherapy[(carboplatin AUC 5 / cisplatin 75mg/m2+ pemetrexed 500mg/m2) every 21 days ×4 cycles + pemetrexed 500mg/m2 every 21 days maintenance] Receives: Drug: Furmonertinib 160mg QD plus Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Progression-free survival (PFS) assessed by INV per RECIST v1.1 in the FAS population.
Measured: Up to 2 years
Secondary outcomes (5)
Disease Control Rate (DCR)
Measured: Analysis will occur when PFS maturity is observed at approximately 12 months from the first patient begin study treatment
Objective Response Rate(ORR)
Efficacy measures such as overall response rate (ORR), which is the proportion of subjects with CR or PR by INV based on RECIST v1.1
Measured: Up to 2 years
Duration of Response (DoR)
Duration of response (DoR), which is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.
Measured: Up to 2 years
Overall Survival（OS）
Overall Survival (OS) in the FAS population
Measured: Up to 2 years
Time to Subsequent Therapy (TTST)
TTST is defined as the time from the date of randomization to the start date of the subsequent anti-cancer therapy following study treatment discontinuation, or death whichever comes first.
Measured: Up to 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 Oct 2024
- Study start1 Oct 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jialei Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jialei Wang, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06652048
- Sponsor's protocol ID
- FLAME-003-AST2818
- Status last verified
- Nov 2025
- First submitted
- 10 Oct 2024
- Last updated
- 21 Nov 2025
- 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 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-dose Furmonertinib or Combined With Pemetrexed and Carboplatin/Cisplatin in EGFR-sensitive Mutation Advanced NSCLC After Disease Progression on First-line Treatment of Third-generation EGFR-TKI:a Multicencer,Open-label,Randomized Phase II Study
- ClinicalTrials.gov ID
- NCT06652048
- Acronym / sponsor ID
- FLAME-003-AST2818
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jialei WangUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 22 Oct 2024 (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 is a multicenter, open-label,randomised phase II study planned to include 60 subjects with EGFR-sensitive mutation advanced NSCLC after disease progression on first-line treatment with third-generation EGFR-TKI.Eligible patients will randomly be assigned in a 1:1:1 ratio to receive 160mg/240mg furmonertinib p.o qd or 160mg furmonertinib p.o qd plus chemotherapy[(carboplatin AUC 5 / cisplatin 75mg/m2+ pemetrexed 500mg/m2) every 21 days ×4 cycles + pemetrexed 500mg/m2 every 21 days maintenance].Patients will be followed up every 2 cycles during the first half year , and every 3 cycles after the first half year.Treatment was continued until disease progression,intolerable toxic effects, investigator decision, patient withdrawal of consent, or death, whichever occurred first.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Furmonertinib 160mg QD | Experimental | Drug: Furmonertinib 160mg QDAll patients enrolled into this group will receive furmonertinib 160mg p.o qd. |
| Furmonertinib 240mg QD | Experimental | Drug: Furmonertinib 240mg QDAll patients enrolled into this group will receive furmonertinib 240mg p.o qd. |
| Furmonertinib 160mg QD plus Chemotherapy | Experimental | Drug: Furmonertinib 160mg QD plus ChemotherapyAll patients enrolled into this group will receive furmonertinib 160mg furmonertinib p.o qd plus chemotherapy[(carboplatin AUC 5 / cisplatin 75mg/m2+ pemetrexed 500mg/m2) every 21 days ×4 cycles + pemetrexed 500mg/m2 every 21 days maintenance] |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Locally advanced or metastatic non-small cell lung cancer ;
- Histologically or haematologically confirmed EGFR-sensitive mutations;
- Developed radiological progression after first-line third-generation EGFR-TKI monotherapy without any other subsequent systemic therapy. Patients received Osimertinib or Almonertinib for at least 3 months prior to progression and were discontinued 8 days prior to randomization, patients received Furmonertinib prior to progression achieved remission or sustained clinical benefit for at least 6 months (progression occurred during or \<6 months after the last dose when the third-generation EGFR-TKI as a neoadjuvant/adjuvant , EGFR-TKI is considered as first-line treatment); Patients who had previously received chemotherapy or immunotherapy as neoadjuvant or adjuvant therapy could be included if they had metastatic/recurrent disease diagnosed more than 6 months after the last treatment and had radiographic progression after third-generation EGFR-TKI therapy;
- Patient has at least one accurately measurable lesion that has not been previously irradiated or biopsied during the screening period, according to RECIST 1.1; If the patient has one and only one measurable lesion, tissue biopsy of the lesion is permitted if the investigator assesses has limited impact on lesion detection, but baseline imaging of the lesion should be performed after tissue biopsy;
- Age ≥18 years old;
Key exclusion criteria (27 listed)
- The tumor is confirmed by histology or cytology to be complicated with small cell lung cancer, neuroendocrine carcinoma, carcinosarcoma component or squamous cell carcinoma component exceeding 10%;
- There are other driver gene mutations with known drug therapy (such as MET amplification, RET fusion, BRAF V600E mutation, etc.);
- Allergy to the study drug and/or its excipients is known or suspected;
- Treatment with any of the following:
- The toxicity associated with previous antitumor therapy did not return to ≤CTCAE Class 1, except for hair loss or chemotherapy-induced ≤CTCAE class 2 peripheral neurotoxicity;
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 |
|---|---|---|
| Furmonertinib 160mg QDAll patients enrolled into this group will receive furmonertinib 160mg p.o qd. | Drug | Furmonertinib 160mg QD |
| Furmonertinib 240mg QDAll patients enrolled into this group will receive furmonertinib 240mg p.o qd. | Drug | Furmonertinib 240mg QD |
| Furmonertinib 160mg QD plus ChemotherapyAll patients enrolled into this group will receive furmonertinib 160mg furmonertinib p.o qd plus chemotherapy[(carboplatin AUC 5 / cisplatin 75mg/m2+ pemetrexed 500mg/m2) every 21 days ×4 cycles + pemetrexed 500mg/m2 every 21 days maintenance] | Drug | Furmonertinib 160mg QD plus Chemotherapy |
Primary outcome
Progression-free survival (PFS)
Time frame: Up to 2 years
Progression-free survival (PFS) assessed by INV per RECIST v1.1 in the FAS population.
5 secondary outcomes
Disease Control Rate (DCR)
Time frame: Analysis will occur when PFS maturity is observed at approximately 12 months from the first patient begin study treatment
Objective Response Rate(ORR)
Time frame: Up to 2 years
Duration of Response (DoR)
Time frame: Up to 2 years
Overall Survival（OS）
Time frame: Up to 2 years
Time to Subsequent Therapy (TTST)
Time frame: Up to 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 21 Nov 2025.
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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 Furmonertinib 160mg QD, Furmonertinib 240mg QD and Furmonertinib 160mg QD plus Chemotherapy in people with Non-Small Cell Lung Cancer, run by Jialei Wang 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 10 inclusion and 27 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 21 Nov 2025. 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 Jialei Wang (18017312369, wangjialei@shca.org.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: Up to 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 21 Nov 2025.