Actively Recruiting
Neo-Bio-ADAURA: a Phase II Study to Evaluate Mechanisms of Resistance to Neoadjuvant Osimertinib
Led by Jair Bar, M.D., Ph.D. · Updated on 2024-12-04
20
Participants Needed
2
Research Sites
306 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 \[Ex19del\]).
CONDITIONS
Official Title
Neo-Bio-ADAURA: a Phase II Study to Evaluate Mechanisms of Resistance to Neoadjuvant Osimertinib
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent, including for correlative translational studies
- Male or female aged 18 years or older at consent
- Histologically or cytologically confirmed non-squamous NSCLC with completely resectable stage II-III disease
- Complete surgical resection of primary NSCLC deemed achievable by multidisciplinary team including thoracic surgeon
- Performance status ECOG 0-1 with no deterioration in prior 2 weeks
- Lung and cardiac function adequate for curative surgery as assessed by thoracic surgeon and ECHO
- Adequate normal organ and marrow function including neutrophil count ≥1.5x10⁹/L, platelet count ≥100x10⁹/L, hemoglobin ≥9.0 g/dL without support, ALT and AST ≤2.5x ULN, total bilirubin ≤1.5x ULN (or up to 2x ULN with Gilbert's disease), creatinine ≤1.5x ULN or clearance ≥50 mL/min (≥60 mL/min if neoadjuvant chemotherapy planned)
- Body weight over 30 kg
- Life expectancy greater than 6 months
- Tumor harboring EGFR sensitizing mutation L858R or exon 19 deletion, alone or with other EGFR mutations; exon 20 insertion mutations excluded
- Female patients of childbearing potential must use effective contraception and have negative pregnancy test prior to dosing or meet criteria for non-childbearing potential
- Male patients willing to use barrier contraception
You will not qualify if you...
- Known active infection with hepatitis C virus or tuberculosis; HCV antibody positive only if PCR negative for HCV RNA
- Known active or uncontrolled hepatitis B virus infection unless meeting specific criteria with antiviral treatment and suppressed viral load
- HIV active infection unless viral RNA undetectable for 6 months, CD4+ count >350, no recent AIDS-defining infections, and stable on treatment
- History of interstitial lung disease, drug-induced ILD, or radiation pneumonitis requiring steroids
- History of other primary malignancy except certain treated cancers with no active disease for ≥3 years
- Pre-operative radiotherapy planned
- Conditions affecting ability to swallow osimertinib or absorption issues
- Mixed small cell and NSCLC histology
- Tumors invading aorta, esophagus, heart, or bulky N2 disease
- Significant cardiac abnormalities including QTc >470 msec or arrhythmias
- Pregnant or breastfeeding
- Unresolved toxicities > grade 1 from prior therapy except alopecia or grade 2 neuropathy
- Prior systemic anti-cancer or EGFR-TKI treatment for NSCLC within 12 months
- Use of strong CYP3A4 inducers within 3 weeks before starting study drug
- Ongoing immunosuppressive therapy
- Major surgery within 28 days before first dose except minor procedures
- Participation in planning or conduct of this study
- Recent investigational drug use within 3 months or 5 half-lives
- Concurrent enrollment in other interventional trials
- Prior participation in osimertinib trials or this study
- Known allergy to study drugs or similar compounds
- Inability to comply with study procedures or give informed consent
- Any condition interfering with safety evaluation or study results, including uncontrolled infections or significant cardiac, pulmonary, or psychiatric conditions
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Sheba Medical Center
Ramat Gan, Israel, Israel, 522651
Actively Recruiting
2
Sheba Medical Center, Jusidman Cancer Center
Ramat Gan, Israel, Israel, 5590000
Actively Recruiting
Research Team
S
Sheba medical center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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