A Phase II, Single-Arm, Prospective Study of Neoadjuvant Icotinib With Chemotherapy for the Treatment of Patients With Epidermal Growth Factor Receptor Mutation Positive, Resectable for Stage II to IIIB(N2) Non-small Cell Lung Cancer

Who is this study for? Patients with epidermal growth factor receptor mutation positive, resectable for stage II to IIIB(N2) non-small cell lung cancer
What treatments are being studied? Icotinib+Cisplatin+Carboplatin+Pemetrexed
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a Phase II, single-Arm, prospective study of neoadjuvant Icotinib with chemotherapy for the treatment of patients with epidermal growth factor receptor mutation positive, resectable for stage II to IIIB(N2) Non-small Cell Lung Cancer

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

• Male or female, at least 18 years of age.

• Histologically or cytologically documented lung adenocarcinoma within 60 days prior to study enrollment.

• Clinical stage IIA/IIB/IIIA/IIIB assessed by EBUS-TBNA or PET(positron emission tomography)/CT can be resected.

• EGFR mutation was detected by Amplification Refractory Mutation System(ARMS) and confirmed to be one of the 2 common EGFR mutations known to be associated with EGFR-TKI (epidermal growth factor receptor tyrosine kinase inhibitors)sensitivity (Ex19del, L858R).

• Presence of at least one accurately measurable lesion, CT showing a maximum diameter of 10mm at baseline (except for lymph nodes with a short axis of 15mm required) and suitable for accurate repeat measurements.

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at enrolment.

• Hematology , liver and kidney function are adequate for neoadjuvant therapy.

• Cardiopulmonary function suitable for surgical treatment (ECG, echocardiography, pulmonary function or blood gas analysis).

• Serum pregnancy test (for females of childbearing potential) negative at screening.Female patients of non-childbearing potential must meet at least 1 of the following criteria:

• ① Achieved postmenopausal status, defined as follows: cessation of regular menses forat least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed with a serum follicle- stimulating hormone (FSH)level confirming the postmenopausal state;

• ② Have undergone a documented hysterectomy and/or bilateral oophorectomy;

• ③ Have medically confirmed ovarian failure. All other female patients (including female patients with tubal ligations) are considered to be of childbearing potential.

• Male subjects must be willing to use barrier contraception

Locations
Other Locations
China
BeijingCancerH
RECRUITING
Beijing
Contact Information
Primary
NAN Wu, M.D.
nanwu@bjmu.edu.cn
8613466692698
Time Frame
Start Date: 2021-10-25
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 27
Treatments
Experimental: Icotinib with platinum-based chemotherapy
Icotinib 125 mg TID plus investigator's choice of platinum-based standard of care chemotherapy (pemetrexed/carboplatin or pemetrexed/cisplatin)
Sponsors
Leads: Peking University Cancer Hospital & Institute

This content was sourced from clinicaltrials.gov