Lung cancer
Conditions
Interventions
Case series:neoadjuvant osimertinib
Sponsors
Thoracic Surgery II, Beijing Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Provision of informed consent prior to any study specific procedures; 2. Aged between 18 and 75 years old; 3. Histology or cytology confirmed lung adenocarcinoma, performed on a biopsy that occurred within 60 days before study enrollment; 4. Stage II-IIIB resectable diseases evaluated by EBUS-TBNA, mediastinoscopy (N2) or PET/CT; 5. Tested and confirmed to be EGFR mutation-positive (including exon 19 deletion and exon 21 L858R); 6. At least one lesion that can be accurately measured at baseline as >= 10 mm in the longest diameter (except lymph nodes which must have short axis >= 15 mm) with computed tomography (CT) and which is suitable for accurate repeated measurements; 7. ECOG performance status of 0-1; 8. adequate hematological and hepatic-renal functions that are required for neoadjuvant therapy; 9. Qualified cardiopulmonary function that is required for surgical resection; 10. Female subjects should be using highly effective contraceptive measures for at least 2 weeks prior to the initiation of study drug, and must have a negative pregnancy test and not be breast-feeding prior to start of dosing if of child-bearing potential or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening: (1) Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatment; (2) Women under 50 years old would be consider postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the post-menopausal range for the institution; (3) Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation; 11. Male subjects should be willing to use barrier contraception.
Exclusion criteria
Exclusion criteria: 1. Tumor with squamous cell lung cancer or small cell lung cancer component; 2. Exposure to other anticancer treatment before enrollment; 3. Harboring EGFR exon 20 mutation of insertion; 4. Patients are pregnant or breast-feeding; 5. Currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inducers of CYP3A4 (at least 3 week prior) (Appendix B). All patients must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known inducer effects on CYP3A4; 6. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigators opinion makes it undesirable for the patient to participate in the trial or which would jeopardise compliance with the protocol, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required; 7. Any of the following cardiac criteria: (1) Mean resting corrected QT interval (QTc) > 470 msec obtained from 3 electrocardiograms (ECGs), using the screening clinic ECG machine derived QTc value; (2) Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g. complete left bundle branch block, third degree heart block and second degree heart block; (3) Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval; 8. Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease; 9. Inadequate bone marrow reserve or organ function (as demonstrated by any of the following laboratory values: absolute neutrophil count 2.5 times ULN; aspartate aminotransferase > 2.5 times ULN; total bilirubin >1.5 times ULN; serum creatinine > 1.5 times ULN concurrent with creatinine clearance 1.5 times ULN); 10. History of hypersensitivity active or inactive excipients of osimertinib or drugs with a similar chemical structure or class to osimertinib; 11. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of Osimertinib; 12. Any evidence of corneal injuries diagnosed by ophthalmologic examination with slit lamp evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse events and perioperative complications;quality of life (QoL);pathological complete response (pCR) rate and N2 downstaging rate;major pathological response (MPR) rate;R0 resection rate; | — |
Countries
China
Contacts
Public ContactYue Yang
Beijing Cancer Hospital
Outcome results
None listed