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 (Jun 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
Treatments studied
Targeted therapy
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR e709x
Required: EGFR exon 19 deletion
Required: EGFR exon 19 insertion
Required: EGFR g719x
Required: EGFR l858r
Required: EGFR l861q
Required: EGFR s768i
Excluded: EGFR exon 20 insertion
Disease stage
Required: Stage IIIB, IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: anti-VEGF agent
Patient 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, with known start date and required baseline imaging completed prior to osimertinib start, the patient is 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
Patient must not have had any prior systemic treatment for metastatic disease
Lab requirements
Blood counts
Leukocytes ≥ 3,000/mcL; ANC ≥ 1,500/mcL; Platelets ≥ 100,000/mcL; Hemoglobin ≥ 9 g/dL
Kidney function
Total bilirubin and 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 class 2B or better; no mean resting QTc > 470 msec; no clinically important ECG abnormalities; no factors increasing risk of QTc prolongation or arrhythmic events
Leukocytes ≥ 3,000/mcL (≤ 14 days prior to randomization); ANC ≥ 1,500/mcL; Platelets ≥ 100,000/mcL; Hemoglobin ≥ 9 g/dL; Total bilirubin and creatinine ≤ 1.5 x institutional ULN; AST/ALT ≤ 2.5 x institutional ULN; NYHA class 2B or better; no mean resting QTc > 470 msec; no clinically important ECG abnormalities; no factors increasing risk of QTc prolongation or arrhythmic events
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Anchorage Associates in Radiation Medicine · Anchorage, Alaska
- Anchorage Radiation Therapy Center · Anchorage, Alaska
- Alaska Breast Care and Surgery LLC · Anchorage, Alaska
- Alaska Oncology and Hematology LLC · Anchorage, Alaska
- Alaska Women's Cancer Care · Anchorage, Alaska
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04181060 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-VEGF agent, EGFR tyrosine kinase inhibitor, systemic treatment for metastatic disease disqualifies patients from enrollment.
Does this trial require EGFR?
Yes, EGFR e709x is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR exon 19 deletion is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR exon 19 insertion is a required biomarker for enrollment.
Are patients with EGFR alterations eligible?
No. EGFR exon 20 insertion is an exclusion criterion.
What disease stage is eligible?
Stage IIIB or IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify