What is this study trying to find out about advanced EGFR-mutant lung cancer?

This study compares osimertinib alone versus osimertinib combined with bevacizumab to see which works better as first treatment for advanced lung cancer with EGFR mutations. Researchers want to learn how these treatments affect how long patients live without cancer worsening and overall survival. The National Cancer Institute sponsors this trial to improve treatment options.

Who may be eligible for this advanced lung cancer clinical trial?

Adults aged 18 or older with advanced non-squamous non-small cell lung cancer and specific EGFR mutations may be eligible. Participants must have no prior anti-VEGF or systemic treatment for metastatic disease and meet certain health criteria. This trial accepts all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this advanced lung cancer clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID04181060

Comparing Osimertinib Alone or With Bevacizumab for Advanced EGFR-Mutant Non-Small Cell Lung Cancer Treatment

Led by National Cancer Institute (NCI) · Updated on 2026-08-10

300

Participants Needed

603

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

This trial studies adults with advanced non-small cell lung cancer NSCLC that has spread outside the lungs and has specific mutations in the EGFR gene. Researchers are comparing two treatment approaches osimertinib alone versus osimertinib combined with bevacizumab. The study aims to evaluate how these treatments affect the time patients live without disease progression and overall survival, as well as their effects on brain metastases and treatment safety. Participants are randomly assigned to one of two groups. One group receives osimertinib pills daily every 21 days, while the other group receives osimertinib daily plus an intravenous infusion of bevacizumab every 21 days. Treatment continues until disease progression or unacceptable side effects occur. During the study, participants undergo tests including echocardiography, MUGA scans, CT scans, and possibly MRI, along with blood and urine sample collection. After treatment ends, participants are followed every three months for up to 10 years to monitor disease status and survival. Researchers will assess progression-free survival, overall survival, response rates, time to brain progression, and side effects. The study includes long-term follow-up to understand the lasting effects of these treatments and to explore resistance mechanisms through tumor DNA analysis.

CONDITIONS

Brief 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...

Diagnosis of non-squamous, non-small cell lung cancer
Advanced disease defined as stage IV, stage IIIB not suitable for multi-modality therapy, or recurrent disease
Presence of activating EGFR mutation (excluding exon 20 insertions)
No prior treatment with anti-VEGF agents
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 negative pregnancy test
Use of effective contraception or abstinence during study and for specified periods after treatment
Adequate blood counts and organ function within 14 days prior to randomization
HIV patients on effective therapy with undetectable viral load eligible
Treated or stable brain metastases allowed under specific conditions
Ability to understand and sign informed consent
No investigational drug use within 5 half-lives or 3 months prior to study
No use of strong CYP3A4 inducers before starting treatment
No unresolved toxicities greater than CTCAE grade 1 except alopecia and certain neuropathies
No severe or uncontrolled systemic diseases that interfere with participation
No history of interstitial lung disease or certain lung conditions
No history of hypersensitivity to osimertinib or similar drugs
QTc interval ≤ 470 msec and no significant ECG abnormalities
No risk factors increasing QT prolongation or arrhythmia

You will not qualify if you...

Non-sensitizing EGFR mutations such as exon 20 insertions
Prior treatment with EGFR tyrosine kinase inhibitors except recent osimertinib started within 21 days with proper baseline imaging
Active cardiovascular disease, uncontrolled hypertension, or significant proteinuria
Tumor invading major blood vessels
Pregnancy or breastfeeding
Use of medications or supplements that strongly induce CYP3A4 not discontinued prior to treatment
Unresolved toxicities greater than CTCAE grade 1 except alopecia and certain neuropathies
Severe or uncontrolled systemic disease making study participation difficult
History or active interstitial lung disease or radiation pneumonitis requiring steroids
Hypersensitivity to osimertinib or related drugs
QTc > 470 msec or significant ECG conduction abnormalities
Risk factors for QT prolongation or torsades de pointes
Inability to swallow osimertinib tablets or previous bowel resection affecting absorption

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Comparing Osimertinib Alone or With Bevacizumab for Advanced EGFR-Mutant Non-Small Cell Lung Cancer Treatment

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria