Osimertinib With or Without Bevacizumab as Initial Treatment for Patients With EGFR-Mutant Lung Cancer

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

NCT04181060

Osimertinib With or Without Bevacizumab as Initial Treatment for Patients With EGFR-Mutant Lung Cancer

Led by National Cancer Institute (NCI) · Updated on 2026-05-14

300

Participants Needed

604

Research Sites

313 weeks

Total Duration

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Osimertinib With or Without Bevacizumab as Initial Treatment for Patients With EGFR-Mutant Lung Cancer

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Pathologically confirmed diagnosis of non-squamous non-small cell lung cancer
Advanced disease: stage IV, stage IIIB not suitable for definitive therapy, or recurrent disease post stage I-III
Presence of activating EGFR mutation (e.g., Exon 19 deletion, L858R)
No prior treatment with anti-VEGF agents
Prior radiation allowed if completed one week (limited field) or two weeks (whole-brain) before treatment
No significant risk factors for anti-VEGF therapy such as hemoptysis or uncontrolled cardiovascular conditions
Measurable disease with baseline scans within 4 weeks prior to randomization
No prior systemic treatment for metastatic disease
Age 18 years or older
ECOG performance status 0 to 2
Not pregnant or breastfeeding; females of childbearing potential must have a recent negative pregnancy test
Use effective contraception during and after treatment as specified
Adequate blood counts and organ function per protocol
HIV patients with undetectable viral load on therapy eligible
Controlled hepatitis B or cured hepatitis C eligible
Treated or stable brain metastases allowed if neurologically stable and off steroids
Patients with prior or concurrent malignancy allowed if it does not interfere with study
Cardiac function class 2B or better per NYHA classification
Ability to understand and sign informed consent
No investigational drug within 5 half-lives or 3 months prior
No strong CYP3A4 inducers during treatment
No unresolved toxicities greater than grade 1 except alopecia and grade 2 neuropathy
No severe uncontrolled systemic disease
No gastrointestinal conditions affecting osimertinib absorption
No history of interstitial lung disease or related lung conditions
No hypersensitivity to osimertinib or similar drugs
QTc interval 470 msec or less
No serious ECG abnormalities or risk factors for arrhythmia

You will not qualify if you...

Non-activating EGFR mutations such as exon 20 insertions
Prior treatment with EGFR tyrosine kinase inhibitors except limited osimertinib use within 21 days before randomization
Presence of active cardiovascular disease or uncontrolled hypertension
Significant proteinuria (>300 mg/dl)
Tumor invading major blood vessels
Pregnancy or breastfeeding
Use of strong CYP3A4 inducers that cannot be stopped prior to treatment
Unresolved toxicities from prior therapy greater than grade 1 (except alopecia and grade 2 neuropathy)
Severe or uncontrolled systemic diseases affecting participation
Refractory nausea, vomiting, or gastrointestinal absorption issues
History of interstitial lung disease or drug-induced lung disease requiring steroids
Hypersensitivity to osimertinib or similar chemical class drugs
QTc interval longer than 470 msec or serious ECG abnormalities
Factors increasing risk of QTc prolongation or arrhythmia such as electrolyte imbalances, congenital long QT syndrome, or family history of sudden cardiac death under 40 years of age

AI-Screening

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Trial Site Locations

Total: 604 locations

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, United States, 98508

Suspended

Anchorage Radiation Therapy Center

Anchorage, Alaska, United States, 99504

Suspended

Alaska Breast Care and Surgery LLC