Neo-Bio-ADAURA: a Single Arm, Multi-Centre Phase II Study to Evaluate Mechanisms of Resistance to Neoadjuvant Osimertinib.

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This study is a single-arm phase II study of neoadjuvant osimertinib as monotherapy for the treatment of patients with resectable stage II-III non-small cell lung cancer (NSCLC) harboring an epidermal growth factor receptor (EGFR) sensitizing mutation (L858R or deletion in exon 19 \[Ex19del\]).

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

• Be willing and able to provide written informed consent for the trial prior to any study specific procedures. The subject must also provide consent for correlative translational study.

• Male or female subjects who are ≥18 years of age on the day of signing the informed consent.

• Histologically or cytologically documented non-squamous NSCLC with completely resectable (Stage II-III) disease.

∙ Note: thick needle biopsy of endobronchial ultrasound (EBUS)/bronchoscopy is acceptable.

• Complete surgical resection of the primary NSCLC must be deemed achievable, as assessed by a multi-disciplinary team evaluation (which should include a thoracic surgeon, specialised in oncologic procedures).

• Performance status (ECOG) 0-1 at enrolment, with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.

• Lung function test results allowing curative surgery by thoracic surgeon's assessment.

• Cardiac function by ECHO cardiography results allowing curative surgery by thoracic surgeon's assessment.

• Have adequate normal organ and marrow function, including the following:

‣ Absolute neutrophil count ≥1.5×109/L.

⁃ Platelet count ≥ 100×109/L.

⁃ Haemoglobin ≥ 9.0 g/dL. Note: The use of granulocyte colony stimulating factor (G-CSF) support, platelet transfusion and blood transfusions to meet these criteria is not permitted.

⁃ Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times the upper limit of normal (ULN).

⁃ Total bilirubin (TBL) ≤1.5 times the ULN or for patients with documented/suspected Gilbert's disease, bilirubin ≤2 times the ULN.

⁃ Creatinine ≤1.5 times the ULN or creatinine clearance ≥50 mL/min (creatinine clearance can be measured or calculated by Cockcroft and Gault equation). If neoadjuvant chemotherapy is part of the neoadjuvant treatment regimen3, calculated creatinine clearance must be ≥60 mL/min.

• Body weight \>30 kg.

• Life expectancy of \>6 months prior to enrolment.

• A tumour which harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations (ie, T790M, G719X, S7681 and L861Q). Exon 20 insertion co-mutation are not permitted.

• Female patients who are not abstinent (in line with the preferred and usual lifestyle choice of the patient) and intend to be sexually active with a male partner must use highly effective contraceptive measures. Women of child-bearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required prior to the first dose of any study treatment if they are of child-bearing potential; or must have evidence of non-child-bearing potential by fulfilling 1 of the following criteria at screening:

‣ Post-menopausal, defined as 50 years of age or more and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments.

⁃ Women under 50 years old would be considered as postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and have luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in the post-menopausal range for the institution.

⁃ Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation (Further information is available in Appendix B (Definition of Women of Childbearing Potential and Acceptable Contraceptive Methods).

• Male patients must be willing to use barrier contraception.

Locations
Other Locations
Israel
Sheba Medical Center
RECRUITING
Ramat Gan
Sheba Medical Center, Jusidman Cancer Center
RECRUITING
Ramat Gan
Contact Information
Primary
Sheba medical center
Jair.Bar@sheba.health.gov.il
+972546288901
Time Frame
Start Date: 2024-02-19
Estimated Completion Date: 2030-01-01
Participants
Target number of participants: 20
Treatments
Experimental: neoadjuvant osimertinib
Osimertinib 80 mg QD
Sponsors
Leads: Jair Bar, M.D., Ph.D.

This content was sourced from clinicaltrials.gov

Similar Clinical Trials