OncoMatch/Clinical Trials/NCT04181060
Osimertinib With or Without Bevacizumab as Initial Treatment for Patients With EGFR-Mutant Lung Cancer
Is NCT04181060 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Bevacizumab and Osimertinib for advanced lung non-squamous non-small cell carcinoma.
Treatment: Bevacizumab · Osimertinib — This phase III trial compares the effect of bevacizumab and osimertinib combination vs. osimertinib alone for the treatment of non-small cell lung cancer that has spread outside of the lungs (stage IIIB-IV) and has a change (mutation) in a gene called EGFR. The EGFR protein is involved in cell signaling pathways that control cell division and survival. Sometimes, mutations in the EGFR gene cause EGFR proteins to be made in higher than normal amounts on some types of cancer cells. This causes cancer cells to divide more rapidly. Osimertinib may stop the growth of tumor cells by blocking EGFR that is needed for cell growth in this type of cancer. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving osimertinib with bevacizumab may control cancer for longer and help patients live longer as compared to osimertinib alone.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR ex19del, L858R, E709X, G719X, ex19ins, L861Q, S768I
somatic activating sensitizing mutation in EGFR (e.g. but not limited to Exon 19 deletion, L858R, E709X, G719X, exon 19 insertions, L861Q, S768I). Patients with non-sensitizing mutations in EGFR (EGFR exon 20 insertions) are not eligible.
Disease stage
Required: Stage IIIB, IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: anti-VEGF agent
must not have received any prior treatment with an anti-VEGF agent
Cannot have received: EGFR tyrosine kinase inhibitor (osimertinib)
Exception: If a candidate has already started osimertinib within 21 days prior to randomization, the exact osimertinib start date is known, and the patient had the required study baseline imaging completed prior to the osimertinib start date, the patient will be eligible
Prior treatment with an EGFR TKI is not allowed, however if a candidate for this study has already started osimertinib within 21 days prior to randomization, the exact osimertinib start date is known, and the patient had the required study baseline imaging completed prior to the osimertinib start date, the patient will be eligible
Cannot have received: systemic treatment for metastatic disease
must not have had any prior systemic treatment for metastatic disease
Cannot have received: investigational drug
must not have had treatment with any investigational drug within five half-lives or 3 months (whichever is greater), prior to study initiation
Lab requirements
Blood counts
Leukocytes ≥ 3,000/mcL; ANC ≥ 1,500/mcL; Platelets ≥ 100,000/mcL; Hemoglobin ≥ 9 g/dL
Kidney function
creatinine ≤ 1.5 x institutional ULN
Liver function
Total bilirubin and creatinine ≤ 1.5 x institutional ULN; AST/ALT ≤ 2.5 x institutional ULN
Cardiac function
NYHA Functional Classification class 2B or better
Leukocytes ≥ 3,000/mcL (obtained ≤ 14 days prior to randomization); Absolute neutrophil count ≥ 1,500/mcL (obtained ≤ 14 days prior to randomization); Platelets ≥ 100,000/mcL (obtained ≤ 14 days prior to randomization); Hemoglobin ≥ 9 g/dL (obtained ≤ 14 days prior to randomization); Total bilirubin and creatinine ≤ 1.5 x institutional upper limit of normal (ULN) (obtained ≤ 14 days prior to randomization); AST/ALT ≤ 2.5 x institutional ULN (obtained ≤ 14 days prior to randomization); NYHA Functional Classification class 2B or better
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Providence Newberg Medical Center · Newberg, Oregon
- Saint Alphonsus Cancer Care Center-Ontario · Ontario, Oregon
- Providence Willamette Falls Medical Center · Oregon City, Oregon
- Providence Portland Medical Center · Portland, Oregon
- Providence Saint Vincent Medical Center · Portland, Oregon
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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