Computed Tomography / Metastatic Lung Non Squamous Non Small Cell Carcinoma / Advanced Lung Non Squamous Non Small Cell Carcinoma · Phase 3 Trial

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

ClinicalTrials.gov · August 19, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 3 trial registration comparing osimertinib plus bevacizumab versus osimertinib monotherapy as first-line treatment for EGFR-mutant advanced or metastatic non-squamous NSCLC. No results are posted in this registry record; the study is actively recruiting, and outcome data are not yet available for clinical interpretation.

What was studied

Phase 3, Interventional, Randomized, Parallel, Open label, Treatment purpose. Advanced Lung Non-Squamous Non-Small Cell Carcinoma, Metastatic Lung Non-Squamous Non-Small Cell Carcinoma, Recurrent Lung Non-Squamous Non-Small Cell Carcinom…; age from 18 Years. Intervention: Arm B (osimertinib, bevacizumab). Compared with: Arm A (osimertinib) — Active Comparator. n = 300. 603 sites: United States.

Key findings

Safety

This is a registry record only; no efficacy, safety, or outcome results are posted or available for review.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a Phase 3 trial registration with no posted results; the study is actively recruiting and outcome data are not yet available for analysis.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Progression-free survival (PFS) (assessed at From randomization to documented disease progression per Response Evaluation Cr…)

DesignPhase 3, Interventional, Randomized, Parallel, Open label, Treatment purpose

PopulationAdvanced Lung Non-Squamous Non-Small Cell Carcinoma, Metastatic Lung Non-Squamous Non-Small Cell Carcinoma, Recurrent Lung Non-Squamous Non-Small Cell Carcinom…; age from 18 Years

Sample size300

InterventionArm B (osimertinib, bevacizumab)

ComparatorArm A (osimertinib) — Active Comparator

Setting603 sites: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment300

Primary outcome measureProgression-free survival (PFS) from randomization to documented disease progression per RECIST 1.1 or death from any cause, assessed up to 10 years

Study phasePhase 3

Caveats

This is a registry record only; no efficacy, safety, or outcome results are posted or available for review.
Recruitment status is ongoing; follow-up data are not yet mature.
Blinding status, randomization method, and statistical analysis plan are not described in this registry record.
No comparative effect size, hazard ratio, or confidence intervals are available.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

strong

Phase 3 randomized controlled trial comparing two active arms.

Directness

strong

Hard clinical endpoint: progression-free survival per RECIST 1.1.

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record alone.

Risk of bias

insufficient

Registry record does not describe blinding, allocation concealment, or analysis plan.

Sample adequacy

moderate

Planned enrollment 300 participants; appropriate for Phase 3 PFS comparison.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT04181060). This is a study registration, not published results. Lead sponsor: National Cancer Institute (NCI). Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 300 participants (ESTIMATED). Conditions: Advanced Lung Non-Squamous Non-Small Cell Carcinoma, Metastatic Lung Non-Squamous Non-Small Cell Carcinoma, Recurrent Lung Non-Squamous Non-Small Cell Carcinoma, Stage IIIB Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8. Interventions: BIOLOGICAL: Bevacizumab; PROCEDURE: Biospecimen Collection; PROCEDURE: Computed Tomography; PROCEDURE: Echocardiography Test; PROCEDURE: Magnetic Resonance Imaging; PROCEDURE: Multigated Acquisition Scan; DRUG: Osimertinib. Primary outcome measures: Progression-free survival (PFS) , From randomization to documented disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or death from any cause, whichever occurs first, assessed up to 10 years. Brief summary: 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Computed TomographyNational Cancer Institute (NCI)Metastatic Lung Non Squamous Non Small Cell CarcinomaAdvanced Lung Non Squamous Non Small Cell CarcinomaRecurrent Lung Non Squamous Non Small Cell CarcinomaBiospecimen CollectionNCT04181060BevacizumabEchocardiography Test