Status and phase
Conditions
Treatments
About
The purpose of this study is to test the safety of combining the drugs osimertinib and bevacizumab at different dose levels. The investigators want to find out what effects, good and/or bad, taking osimertinib and bevacizumab has on the patient and lung cancer. This study will try to find the best dose of osimertinib and bevacizumab given together that does not cause significant side effects. Once the investigators determine that combining osimertinib and bevacizumab is safe, they want to see if the combination is effective in treating lung cancers with the EGFR mutation.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Written informed consent
Advanced biopsy-proven metastatic non-small cell lung cancer
Somatic activating mutation in EGFR
No prior treatment with an EGFR TKI
No prior treatment with a VEGF inhibitor
Measurable (RECIST 1.1) indicator lesion not previously irradiated
Karnofsky performance status (KPS) ≥ 70%
Age >18 years old
Adequate organ function
Exclusion criteria
Any contra-indications to bevacizumab which include but are not limited to recent
Pregnant or lactating women
Any type of systemic anticancer therapy (chemotherapy or experimental drugs) within 2 weeks of starting treatment on protocol
Any radiotherapy within 1 week of starting treatment on protocol
Any major surgery within 4 weeks of starting treatment on protocol
Any evidence of clinically significant interstitial lung disease
Known hypersensitivity to any component of bevacizumab and osimertinib
Primary purpose
Allocation
Interventional model
Masking
49 participants in 1 patient group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal