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New treatment option for Non Small Cell Lung Cancer NSCLC
Official title Phase Ib/II Study of Vebreltinib With Furmonertinib in NSCLC Patients With c-Met Amplification After EGFR-TKI Failure
ClinicalTrials.gov ID: NCT07087223
What this study is testing
What is Vebreltinib combined with Furmonertinib?
Vebreltinib combined with Furmonertinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for non small cell lung cancer nsclc.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of phase Ib study was to evaluate efficacy and tolerability of the combination of vebreltinib and furmonertinib in patients with locally advanced or metastatic non-small cell lung cancer with c-met amplification after failure of EGFR-TKI treatment; to determine the maximum tolerated dose (MTD), and to evaluate the dose-limiting toxicity (DLT) and (recommended Phase 2 dose) RP2D of vebreltinib with furmonertinib. The goal of phase II study was to evaluate efficacy [overall response rate (ORR), progression-free survival (PFS), and so on] of vebreltinib and furmonertinib in patients with locally advanced or metastatic non-small cell lung cancer with c-met amplification after failure of EGFR-TKI treatment.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Fully aware this study and voluntary to sign the informed consent form, and willing and able to comply with the study procedure.
- Aged ≥18 years, male or female.
- Patients with histologically or cytologically confirmed unresectable and non-suitable for radical surgery, or concurrent chemoradiotherapy , locally...
- Documented EGFR sensitive mutations (exon 19 deletion or exon 21 L858R mutation).
- Disease progression after prior EGFR-TKI therapy. Participants must meet both of the following 2 criteria: (1) ≤1 prior chemotherapy regimen allowed...
You likely can't join if
- Patients with ALK fusion or ROS1 fusion.
- Patients with spinal cord compression, leptomeningeal metastasis, or symptomatic brain metastasis that requires an increase in steroid dosage to...
- Presence of other malignancies (with the exception of any type of carcinoma in situ that has been completely resected, basal cell and squamous cell...
- A history of anti-tumor treatment that meets any of the following criteria: （1）Received traditional Chinese medicine or patent medicine with...
- Uncontrolled hypertension, with the allowance for the initiation or adjustment of antihypertensive medications prior to screening;
- Positive for anti-HIV, or positive for both anti-HCV and HCV-RNA, or positive for HBsAg with HBV-DNA ≥500 IU/mL
See the full eligibility criteria
- Fully aware this study and voluntary to sign the informed consent form, and willing and able to comply with the study procedure.
- Aged ≥18 years, male or female.
- Patients with histologically or cytologically confirmed unresectable and non-suitable for radical surgery, or concurrent chemoradiotherapy , locally advanced or metastatic (stage IIIB, IIIC or IV) NSCLC;
- Documented EGFR sensitive mutations (exon 19 deletion or exon 21 L858R mutation).
- Disease progression after prior EGFR-TKI therapy. Participants must meet both of the following 2 criteria: (1) ≤1 prior chemotherapy regimen allowed besides EGFR-TKI. Combination with anti-angiogenic therapy or...
- For tumor tissue samples, FISH detection shows GCN ≥5 and/or MET/CEP7 ≥2 (FISH results from local testing institutions/central laboratories are acceptable);
- Tissue (wax blocks from pleural effusion centrifugation, if quality-controlled) or blood NGS testing results confirm c-Met amplification with CN ≥2.3 (NGS results from local testing institutions/central laboratories are...
- Absolute neutrophil count ≥1.5×10⁹/L (without the use of growth factors within 7 days prior to the start of treatment);
- Hemoglobin ≥90 g/L (without blood transfusion or use of growth factors within 7 days prior to the start of treatment);
- Platelet count ≥75×10⁹/L (without blood transfusion or use of growth factors within 7 days prior to the start of treatment);
- Serum total bilirubin ≤1.5×upper limit of normal (ULN);
- Serum alanine aminotransferase and aspartate aminotransferase ≤3×ULN (for patients with liver metastases, both AST and ALT ≤5×ULN);
- Creatinine clearance (Ccr) ≥60 mL/min.
- International normalized ratio (INR) ≤1.5×ULN;
- Asymptomatic serum amylase ≤Grade 2 (NCI-CTCAE v5.0). For patients with Grade 2 serum amylase abnormalities at the start of the study, it must be confirmed that there are no signs and/or symptoms suggestive of...
- Serum lipase ≤1.5×ULN. 10. Men with reproductive potential and women of childbearing potential must agree to use effective contraception from the time of signing the informed consent form until 3 months after the last...
- Patients with ALK fusion or ROS1 fusion.
- Patients with spinal cord compression, leptomeningeal metastasis, or symptomatic brain metastasis that requires an increase in steroid dosage to control central nervous system disease. Patients with symptomatic CNS...
- Presence of other malignancies (with the exception of any type of carcinoma in situ that has been completely resected, basal cell and squamous cell skin cancers, or other tumors/cancers that have been treated with...
- A history of anti-tumor treatment that meets any of the following criteria: （1）Received traditional Chinese medicine or patent medicine with anti-tumor indications within 1 week prior to the first dose of the study...
- Uncontrolled hypertension, with the allowance for the initiation or adjustment of antihypertensive medications prior to screening;
- Positive for anti-HIV, or positive for both anti-HCV and HCV-RNA, or positive for HBsAg with HBV-DNA ≥500 IU/mL
- Active keratitis or ulcerative keratitis during the disease phase;
- Active tuberculosis;
- Active infection requiring systemic antimicrobial therapy within 2 weeks prior to the first dose of the study drug;
- Other severe medical conditions or psychiatric disorders, or laboratory abnormalities that, in the investigator's judgment, make the study drug unsuitable for the patient or affect protocol compliance; 8. Cardiac...
The study team makes the final eligibility decision.
Where it's taking place
- Neimeng, Neimeng, China
- Baoding, China
- Baotou, China
- Beijing, China
- Dalian, China
- Tianjin, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Neimeng, Neimeng, China; Baoding, China; Baotou, China; Beijing, China; Dalian, China; Tianjin, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.