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New treatment option for Non-small Cell Lung Cancer
Official title Neoadjuvant Furmonertinib and Cisplatin/Pemetrexed as in EGFR Mutated Stage IIA-IIIB Resectable NSCLC (FORESEE)
ClinicalTrials.gov ID: NCT05430802
What this study is testing
What is Furmonertinib+cisplating/pemetrexed?
Furmonertinib+cisplating/pemetrexed is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for non-small cell lung cancer.
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
- In this single-arm, phase II clinical trial, patients with resectable, EGFR-mutated, stage II-IIIB NSCLC received neoadjuvant therapy with furmonertinib (oral, 80 mg once daily, stopped 1 week preoperatively) in combination with platinum-based doublet chemotherapy every 3 weeks for a total of 3 cycles. Surgery was performed 4-6 weeks after chemotherapy.
- 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
- With written informed consent before any study procedure
- Histology or cytology diagnose of non-small cell lung cancer within 60 days
- Stage IIA-IIIB (T3N2M0 only), with resectable lesion(s) by radiology
- EGFR mutation positive (exon 19 deletions or exon 21 L858R, with or without other EGFR mutations)
- Without prior anti-tumor treatment
You likely can't join if
- EGFR Exon 20 insertions positive
- Mixed with small cell cancer, or other mixed types of lung cancer
- Any prior anti-tumor treatment
- Major surgery within 4 weeks before enrollment
- Women with pregnancy or breastfeeding
- Use of strong CYP3A4 inhibitors within 7 days or strong CYP3A4 inducers within 21 days before enrollment; use of traditional Chinese medicine with...
See the full eligibility criteria
- With written informed consent before any study procedure
- Histology or cytology diagnose of non-small cell lung cancer within 60 days
- Stage IIA-IIIB (T3N2M0 only), with resectable lesion(s) by radiology
- EGFR mutation positive (exon 19 deletions or exon 21 L858R, with or without other EGFR mutations)
- Without prior anti-tumor treatment
- With at least one measurable lesions
- ECOG performance status 0-1
- Using adequate and effective contraception, women should refrain from breastfeeding and have a negative pregnancy test prior to the first administration of the study drug if within during child-bearing age
- EGFR Exon 20 insertions positive
- Mixed with small cell cancer, or other mixed types of lung cancer
- Any prior anti-tumor treatment
- Major surgery within 4 weeks before enrollment
- Women with pregnancy or breastfeeding
- Use of strong CYP3A4 inhibitors within 7 days or strong CYP3A4 inducers within 21 days before enrollment; use of traditional Chinese medicine with anti-tumor effect within 21 days before enrollment
- With history of other malignancy except for radical resected tumors without recurrence for 5 years or more
- With severe or uncontrolled systemic disease such as uncontrolled hypertention, diabetes mellitus, chronic heart failure, unstable angina, myocardial infarction within 1 year, active hemorrhage, active HBV/HCV/HIV or...
- Severe gastrointestinal diseases which may affect the intake and absorption of study drug
- Prolongation of ECG QTc or with relative risk factors
- History of interstitial lung disease or with relative risk factors
- Inadequate organ function of hematology, liver and kidney
- Allergic to study drugs or any component
- Poor adherence or other situation judged by investigator
- Patients who had participated other clinical studies of tumors
The study team makes the final eligibility decision.
Where it's taking place
- Xi'an, Shannxi, 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 Xi'an, Shannxi, 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.