Tangdu Hospital
Xi'an, Shannxi, China
Location status: Recruiting
NCT Number: NCT05430802
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. The primary endpoint was objective response rate (ORR). Secondary endpoints included the pathological complete response (pCR) rate, major pathological response (MPR) rate, TNM downstaging rate, R0 resection rate, EFS, overall survival (OS), drug safety and surgical complications.
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Request Info18 year and older
All sexes
Interventional
Phase 2
Xi'an, Shannxi, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Furmonertinib 80mg/d for 9 weeks and cisplating75mg/m2 d1 iv + pemetrexed 500mg/m2 d1 iv in 21-day cycles for 3 cycles
Time frame: 7 days before surgery
the proportion of patients achieving complete response (CR) or partial response (PR) as assessed by investigators according to RECIST version 1.1
Time frame: 7 days after surgery
MPR was defined as the presence of ≤10% residual viable tumor cells in the primary tumor and all lymph nodes from surgical specimens following R0 resection, and the MPR rate was subsequently calculated as the proportion of patients who achieved MPR
Time frame: 7 days after surgery
pCR was defined as the absence of viable tumor cells in the primary tumor and all sampled regional lymph nodes from surgical specimens following R0 resection, and the pCR rate was calculated as the proportion of patients achieving this response
Time frame: 7 days after surgery
the proportion of patients achieving R0 resection among all patients undergoing tumor resection surgery
Time frame: 7 days before surgery
defined as the proportion of patients whose post-neoadjuvant therapy TNM stage (prior to surgery) was lower than their baseline TNM stage
Time frame: 2 years
defined as the time from the date of informed consent to loss of surgical eligibility due to disease progression, postoperative recurrence, or death from any cause
Time frame: Approximately 5 years following the first dose of study drugs
The time from enrolment to death of any reason
Time frame: Adverse events (AEs) will be followed up for 30 days, serious adverse events (SAEs) will be followed up until resolution (assessed up to 60 days), and surgical complications will be followed up for 90 days.
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 and Number of participants with surgical complications as assessed by Clavien-Dindo
Contact information is provided by the study sponsor or research team.
Tang-Du Hospital
Other
Furmonertinib Combined With Cisplatin/Pemetrexed as Neoadjuvant Therapy in EGFR Mutated Stage IIA-IIIB Resectable Non-small Cell Lung Cancer (FORESEE): a Prospective, Open-label, Single-arm, Phase 2 Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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