Clinical Trials List
Protocol NumberFURMO-004
NCT Number(ClinicalTrials.gov Identfier)NCT05607550
Active
2022-02-01 - 2028-02-15
Phase III
Recruiting7
ICD-10C34.90
Malignant neoplasm of unspecified part of unspecified bronchus or lung
ICD-10C34.91
Malignant neoplasm of unspecified part of right bronchus or lung
ICD-10C34.92
Malignant neoplasm of unspecified part of left bronchus or lung
ICD-10C7A.090
Malignant carcinoid tumor of the bronchus and lung
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9162.9
Malignant neoplasm of bronchus and lung, unspecified
A Global, Phase 3, Randomized, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Furmonertinib Compared to Platinum-Based Chemotherapy as First-Line Treatment for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations (FURVENT)
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Trial Applicant
Syneos Health
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- YEN-HSIANG HUANG Division of Thoracic Medicine
- 李柏昕 Division of Thoracic Medicine
- JENG-SEN TSENG Division of Thoracic Medicine
- KUO-HSUAN HSU Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 吳尚俊 Division of General Internal Medicine
- Chia-Chi Lin Division of Hematology & Oncology
- 許嘉林 Division of General Internal Medicine
- 楊景堯 Division of General Internal Medicine
- Jih-Hsiang Lee Division of Hematology & Oncology
- JIN-YUAN SHIH Division of General Internal Medicine
- 陳冠宇 Division of General Internal Medicine
- 廖唯昱 Division of General Internal Medicine
- Chong-Jen Yu Division of General Internal Medicine
- YEN-TING LIN Division of General Internal Medicine
- WEI-LI MA Division of Hematology & Oncology
- 蔡子修 Division of General Internal Medicine
- CHAO-CHI HO CHAO-CHI HO Division of General Internal Medicine
- 林宗哲 Division of Hematology & Oncology
- 徐偉勛 Division of Hematology & Oncology
- 黃得瑞 Division of Hematology & Oncology
- 廖斌志 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chia-I Shen Division of Thoracic Medicine
- 趙恒勝 Division of Thoracic Medicine
- Yuh-Min Chen Division of Thoracic Medicine
- Chi-Lu Chiang Division of Thoracic Medicine
- Hsu-ching Huang Division of Thoracic Medicine
- YEN-HAN TSENG Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 林俊維 Division of Thoracic Medicine
- 陳正雄 Division of Thoracic Medicine
- 蔡偉宏 Division of Thoracic Medicine
- 林慶雄 Division of Thoracic Medicine
- 黃國揚 Division of Thoracic Medicine
- 林明泰 Division of Thoracic Medicine
- 紀炳銓 Division of Thoracic Medicine
- 詹博強 Division of Thoracic Medicine
- 施穎銘 Division of Thoracic Medicine
- 葉金水 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 莊政皓 Division of Thoracic Medicine
- Inn-Wen Chong Division of Thoracic Medicine
- KUAN-LI WU Division of Thoracic Medicine
- 郭家佑 Division of Thoracic Medicine
- Ying-Ming Tsai Tsai Division of Thoracic Medicine
- 李玫萱 Division of Thoracic Medicine
- Chih-Jen Yang Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Chien-Chung Lin
Co-Principal Investigator
- 蔡政軒 Division of General Internal Medicine
- Chin-Wei Kuo Division of General Internal Medicine
- Wu-Chou Su Division of Hematology & Oncology
- Seu-Chun Yang Division of General Internal Medicine
- Chun-Hui Lee Division of Hematology & Oncology
- Chian-Wei Chen Division of General Internal Medicine
- Shang-Yin Wu
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Metastatic Non-Small Cell Lung Cancer
Objectives
For treatment-naïve patients with locally advanced or metastatic non-squamous NSCLC harboring EGFR exon 20 insertion mutations, progression-free survival (PFS) was used to evaluate the efficacy of furmonertinib compared to platinum-based chemotherapy.
Test Drug
錠劑
Active Ingredient
Furmonertinib (Furmonertinib Mesylate)
Dosage Form
110
Dosage
40 mg/tab
Endpoints
PFS as determined by BICR, where PFS is defined as the time elapsed from randomization until the first disease exacerbation (using RECIST version 1.1) or death from any cause (whichever occurs first).
Inclution Criteria
Key Inclusion Criteria:
Histologically or cytologically documented, locally advanced or metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy.
Documented results of the presence of an Epidermal Growth Factor Receptor (EGFR) exon 20 insertion mutation in tumor tissue or blood from local or central testing.
No prior systemic anticancer therapy regimens received for locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) including prior treatment with any Epidermal Growth Factor Receptor (EGFR)-targeting agents (e.g., previous (EGFR) TKIs, monoclonal antibodies, or bispecific antibodies).
Patients who have received prior neo-adjuvant and/or adjuvant chemotherapy, immunotherapy, or chemo radiotherapy for non-metastatic disease (excluding EGFR-TKIs) must have experienced a treatment free interval of at least 12 months.
Patients with a history of treated CNS metastases or new asymptomatic CNS metastases are eligible.
Histologically or cytologically documented, locally advanced or metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy.
Documented results of the presence of an Epidermal Growth Factor Receptor (EGFR) exon 20 insertion mutation in tumor tissue or blood from local or central testing.
No prior systemic anticancer therapy regimens received for locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) including prior treatment with any Epidermal Growth Factor Receptor (EGFR)-targeting agents (e.g., previous (EGFR) TKIs, monoclonal antibodies, or bispecific antibodies).
Patients who have received prior neo-adjuvant and/or adjuvant chemotherapy, immunotherapy, or chemo radiotherapy for non-metastatic disease (excluding EGFR-TKIs) must have experienced a treatment free interval of at least 12 months.
Patients with a history of treated CNS metastases or new asymptomatic CNS metastases are eligible.
Exclusion Criteria
1. Unable or unwilling to swallow pills.
2. Unable to adhere to trial and follow-up procedures.
3. Malabsorption syndrome or other conditions that interfere with intestinal absorption.
4. Having pleural effusion, pericardial effusion, or ascites requiring repeated drainage procedures twice a week or more.
• Pleural or abdominal catheter placement may be permitted if the patient has fully recovered from surgery, is hemodynamically stable, and has improved symptoms.
5. Severe acute or chronic infection, including:
• Uncontrolled acute infection, active infection requiring systemic treatment, or systemic antibiotic treatment received within 2 weeks prior to the first dose of the investigational drug.
• Patients with uncontrolled human immunodeficiency virus (HIV) infection (defined as CD4+ T cell count < 350 cells/μL).
Note: Patients must have received proven antiretroviral therapy (ART) for at least 4 weeks and have an HIV viral load < 400 copies/mL prior to enrollment. Patients with HIV viral load results below the detection limit of the testing center are considered eligible if the center's detection limit is higher than 400 copies/mL or less than 1 copy/mL. Patients with unknown HIV infection status are ineligible if they do not consent to HIV testing.
• Patients with active chronic hepatitis B or active hepatitis C infection, including those who are positive for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody at screening, are ineligible until further definitive quantitative tests, such as hepatitis B virus (HBV) DNA (e.g., ≤ 2500 copies/mL or 500 IU/mL) and HCV ribonucleic acid (RNA) testing (e.g., ≤ detection limit), definitively rule out active hepatitis B or C infection requiring treatment.
Note: If a patient's HBsAg test result is negative at screening but their total hepatitis B core antibody (HbcAb) test result is positive, HBV DNA testing must also be performed to determine whether the patient is infected with HBV. Patients who are HBV carriers, have stable HBV infection after drug treatment (e.g., HBV DNA quantification shows DNA ≤ 2500 copies/mL or 500 IU/mL), or have been cured of hepatitis C are eligible for inclusion. If the detection limit for HBV DNA testing at the testing center is higher than 2500 cps/mL or 500 IU/mL, then patients with HBV DNA quantification results lower than the testing center's detection limit are considered eligible.
6. In the event of an outbreak or epidemic, screening for active infection should be considered according to local or institutional guidelines or guidelines of applicable medical societies (e.g., American College of Clinical Oncology or European Society for Medical Oncology).
7. Previous history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis, or current ILD.
8. Previous or current clinically significant cardiovascular dysfunction, including the following:
• History of stroke or transient ischemic attack within 6 months prior to the first dose of the investigational drug
• History of myocardial infarction within 6 months prior to the first dose of the investigational drug
• New York Heart Association (NYHA) Class III or IV heart disease, or congestive heart failure requiring medication
• Poorly controlled arrhythmia, or a previous or current ventricular arrhythmia requiring medication
• Symptomatic coronary artery disease or unstable angina
9. Mean resting corrected QT interval (QTc) > 470 msec from three consecutive electrocardiograms (ECGs) (using the Fridericia formula (QTcF) value calculated by the screening clinic ECG machine).
10. Clinically significant QT interval prolongation, or a condition deemed likely to increase by the trial administrator. Other arrhythmias or clinical conditions that may increase the risk of QT prolongation (e.g., complete left bundle branch block, Class III atrioventricular block, Class II cardiac conduction block, PR interval > 250 msec, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death of a first-degree relative under 40 years of age, severe hypokalemia, heart failure) or current use of medications that may prolong the QT interval:
11. Symptomatic hypercalcemia requiring continuous bisphosphonate therapy or denosumab
12. Major trauma or major surgical procedure within 4 weeks prior to day 1 of cycle 1
13. Chronic diarrhea, short bowel syndrome, or major upper gastrointestinal (GI) events. 13. Patients with a history of surgery (including gastrectomy), inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis), or any active bowel inflammation (including diverticulitis)
14. Patients with any other disease, pulmonary dysfunction, metabolic dysfunction, physical examination findings, or clinical laboratory findings that reasonably suggest a disease or condition may preclude the use of the investigational drug, may affect the interpretation of results, or put the patient at high risk of treatment complications (e.g., poorly controlled hypertension, active bleeding)
15. Patients who received radiation therapy (excluding palliative radiation therapy for bone metastases and radiation therapy for CNS metastases) as cancer therapy within 4 weeks prior to starting the investigational treatment
16. Patients who received palliative radiation therapy for bone metastases within 2 weeks prior to starting the investigational drug
17. Patients whose unresolved toxicities from prior therapy (e.g., adjuvant chemotherapy) are still > Grade 1 at the time of starting the investigational drug, excluding hair loss and Grade 2 neuropathy related to prior platinum-based therapy
18. Patients in the 3 days prior to screening Patients with a history of other malignant tumors but with negligible risk of metastasis or death and/or expected to be cured with treatment (e.g., cervical cancer in situ, non-melanoma skin cancer, localized prostate cancer, or ductal carcinoma in situ treated appropriately) are exceptions.
19. Pregnant or breastfeeding, or intending to become pregnant during the trial or within 60 days after the last dose of the investigational drug.
20. Use of a potent cytochrome P450 3A4 (CYP3A4) inhibitor within 7 days before the first dose of the investigational drug, or use of a potent CYP3A4 inducer within 21 days before the first dose of the investigational drug.
21. Use of herbal remedies (e.g., Chinese herbal medicine or traditional Chinese medicine preparations applicable to cancer, or traditional Chinese herbal medicine or traditional Chinese medicine preparations with adjuvant anticancer effects) within 2 weeks before the first dose of the investigational drug, or expected to use them during the trial.
22. History of allergic reaction to any ingredient, including excipients, or the furmonertinib drug product.
23. History of allergic reaction to... Allergic reactions to pemetrexed, cisplatin, carboplatin, other platinum-containing compounds or other components of their preparations
2. Unable to adhere to trial and follow-up procedures.
3. Malabsorption syndrome or other conditions that interfere with intestinal absorption.
4. Having pleural effusion, pericardial effusion, or ascites requiring repeated drainage procedures twice a week or more.
• Pleural or abdominal catheter placement may be permitted if the patient has fully recovered from surgery, is hemodynamically stable, and has improved symptoms.
5. Severe acute or chronic infection, including:
• Uncontrolled acute infection, active infection requiring systemic treatment, or systemic antibiotic treatment received within 2 weeks prior to the first dose of the investigational drug.
• Patients with uncontrolled human immunodeficiency virus (HIV) infection (defined as CD4+ T cell count < 350 cells/μL).
Note: Patients must have received proven antiretroviral therapy (ART) for at least 4 weeks and have an HIV viral load < 400 copies/mL prior to enrollment. Patients with HIV viral load results below the detection limit of the testing center are considered eligible if the center's detection limit is higher than 400 copies/mL or less than 1 copy/mL. Patients with unknown HIV infection status are ineligible if they do not consent to HIV testing.
• Patients with active chronic hepatitis B or active hepatitis C infection, including those who are positive for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody at screening, are ineligible until further definitive quantitative tests, such as hepatitis B virus (HBV) DNA (e.g., ≤ 2500 copies/mL or 500 IU/mL) and HCV ribonucleic acid (RNA) testing (e.g., ≤ detection limit), definitively rule out active hepatitis B or C infection requiring treatment.
Note: If a patient's HBsAg test result is negative at screening but their total hepatitis B core antibody (HbcAb) test result is positive, HBV DNA testing must also be performed to determine whether the patient is infected with HBV. Patients who are HBV carriers, have stable HBV infection after drug treatment (e.g., HBV DNA quantification shows DNA ≤ 2500 copies/mL or 500 IU/mL), or have been cured of hepatitis C are eligible for inclusion. If the detection limit for HBV DNA testing at the testing center is higher than 2500 cps/mL or 500 IU/mL, then patients with HBV DNA quantification results lower than the testing center's detection limit are considered eligible.
6. In the event of an outbreak or epidemic, screening for active infection should be considered according to local or institutional guidelines or guidelines of applicable medical societies (e.g., American College of Clinical Oncology or European Society for Medical Oncology).
7. Previous history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis, or current ILD.
8. Previous or current clinically significant cardiovascular dysfunction, including the following:
• History of stroke or transient ischemic attack within 6 months prior to the first dose of the investigational drug
• History of myocardial infarction within 6 months prior to the first dose of the investigational drug
• New York Heart Association (NYHA) Class III or IV heart disease, or congestive heart failure requiring medication
• Poorly controlled arrhythmia, or a previous or current ventricular arrhythmia requiring medication
• Symptomatic coronary artery disease or unstable angina
9. Mean resting corrected QT interval (QTc) > 470 msec from three consecutive electrocardiograms (ECGs) (using the Fridericia formula (QTcF) value calculated by the screening clinic ECG machine).
10. Clinically significant QT interval prolongation, or a condition deemed likely to increase by the trial administrator. Other arrhythmias or clinical conditions that may increase the risk of QT prolongation (e.g., complete left bundle branch block, Class III atrioventricular block, Class II cardiac conduction block, PR interval > 250 msec, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death of a first-degree relative under 40 years of age, severe hypokalemia, heart failure) or current use of medications that may prolong the QT interval:
11. Symptomatic hypercalcemia requiring continuous bisphosphonate therapy or denosumab
12. Major trauma or major surgical procedure within 4 weeks prior to day 1 of cycle 1
13. Chronic diarrhea, short bowel syndrome, or major upper gastrointestinal (GI) events. 13. Patients with a history of surgery (including gastrectomy), inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis), or any active bowel inflammation (including diverticulitis)
14. Patients with any other disease, pulmonary dysfunction, metabolic dysfunction, physical examination findings, or clinical laboratory findings that reasonably suggest a disease or condition may preclude the use of the investigational drug, may affect the interpretation of results, or put the patient at high risk of treatment complications (e.g., poorly controlled hypertension, active bleeding)
15. Patients who received radiation therapy (excluding palliative radiation therapy for bone metastases and radiation therapy for CNS metastases) as cancer therapy within 4 weeks prior to starting the investigational treatment
16. Patients who received palliative radiation therapy for bone metastases within 2 weeks prior to starting the investigational drug
17. Patients whose unresolved toxicities from prior therapy (e.g., adjuvant chemotherapy) are still > Grade 1 at the time of starting the investigational drug, excluding hair loss and Grade 2 neuropathy related to prior platinum-based therapy
18. Patients in the 3 days prior to screening Patients with a history of other malignant tumors but with negligible risk of metastasis or death and/or expected to be cured with treatment (e.g., cervical cancer in situ, non-melanoma skin cancer, localized prostate cancer, or ductal carcinoma in situ treated appropriately) are exceptions.
19. Pregnant or breastfeeding, or intending to become pregnant during the trial or within 60 days after the last dose of the investigational drug.
20. Use of a potent cytochrome P450 3A4 (CYP3A4) inhibitor within 7 days before the first dose of the investigational drug, or use of a potent CYP3A4 inducer within 21 days before the first dose of the investigational drug.
21. Use of herbal remedies (e.g., Chinese herbal medicine or traditional Chinese medicine preparations applicable to cancer, or traditional Chinese herbal medicine or traditional Chinese medicine preparations with adjuvant anticancer effects) within 2 weeks before the first dose of the investigational drug, or expected to use them during the trial.
22. History of allergic reaction to any ingredient, including excipients, or the furmonertinib drug product.
23. History of allergic reaction to... Allergic reactions to pemetrexed, cisplatin, carboplatin, other platinum-containing compounds or other components of their preparations
The Estimated Number of Participants
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Taiwan
45 participants
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Global
375 participants
