Clinical trial NCT04965831: Furmonertinib as Perioperation Therapy in Stage IIIA-IIIB (N1-N2) Resectable EGFR Mutated Lung Adenocarcinoma (FRONT)
Official title: Furmonertinib Mesylate as Perioperation Therapy in Stage IIIA-IIIB (N1-N2) Resectable, EGFR Sensitizing Mutation Positive Lung Adenocarcinoma Patients: A Phase II, Single-arm, Open-label Clinical Study (FRONT)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Lung Adenocarcinoma
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
Collaborators: name: Allist Pharmaceuticals, Inc.
First posted: 2021-07-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a phase II study aimed to assess the efficacy and safety of furmonertinib, a third generation EGFR TKI, as perioperation therapy in stage IIIA-IIIB (N1-N2) resectable NSCLC patients.

Detailed description: Please refer to detailed description in the following context.

Eligibility criteria: Inclusion Criteria:

* The written informed consent of the patients has been obtained before any examination, sampling and analysis related to the study.
* Primary lung adenocarcinoma diagnosed histologically/cytologically.
* Stages IIIA-IIIB (N1-N2) according to the AJCC 8th edition lung cancer stage and plan to receive radical excision judged by investigators.
* EGFR mutation positive (19Del or L858R, with or without T790M)
* The presence of at least one measurable lesion and suitable for accurate repeated measurements.
* ECOG performance status 0-1.
* For premenopausal women with fertility, the result of serum or urine pregnancy test should be negative within 7 days before the first dose.

Exclusion Criteria:

* Squamous cell carcinoma, and tumors with neuroendocrine components such as large cell carcinoma, or small cell carcinoma.
* Patients with EGFR exon 20 insertion mutation.
* Exposure to other antitumor therapies prior to enrolment.
* Major surgery was performed in the four weeks prior to the first dosing of the study drug.
* Pregnant or lactating female patients.
* Use of CYP3A4 strong depressant within 7 days or CYP3A4 strong inducer within 21 days prior to initial administration.
* Have a history of or present complications with other malignancies.
* Patients with severe or uncontrolled systemic disease requiring treatment were not considered suitable for the study.
* ECG QT interval prolongation or associated risk.
* A history of interstitial pneumonia or related risk.
* Inadequate bone marrow or organ reserve.
* Other circumstances that are not suitable for participation in this study.

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Approximately 8 weeks following the first dose of study drug
Secondary outcomes:
measure: Disease Control Rate (DCR)
timeFrame: Approximately 8 weeks following the first dose of study drug
measure: Progression free survival (PFS)
timeFrame: Approximately 3 years following the first dose of study drug
measure: Disease free survival (DFS)
timeFrame: Approximately 3 years following the first dose of study drug
measure: Adverse Events (AEs)
timeFrame: From the start of study drug to 28 days after the last dose of study drug
Other outcomes:
measure: Circulating tumor DNA clearance rate
timeFrame: Approximately 8 weeks following the first dose of study drug
measure: Minimal residual disease rate
timeFrame: Approximately 12 weeks following the first dose of study drug
Locations:
Study officials:
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Changli Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: