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NCT04181060From ClinicalTrials.govRecruiting

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

Randomized Phase III Study of Combination Osimertinib (AZD9291) and Bevacizumab Versus Osimertinib (AZD9291) Alone as First-Line Treatment for Patients With Metastatic EGFR-Mutant Non-Small Cell Lung Cancer (NSCLC)

  • 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

At a glance

Phase
Phase 3
Study type
Interventional
Sponsor
National Cancer Institute (NCI)
Enrolment target
300
Started
28 December 2020
Main results due
30 June 2029
Study sites
603
Registry updated
29 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
Inclusion Criteria:

* Patient must have a pathologically-confirmed diagnosis of non-squamous, non-small cell lung cancer (NSCLC)
* Patient must have advanced disease, defined as - either stage IV disease, stage IIIB disease not amenable to definitive multi-modality therapy, or recurrent disease after a prior diagnosis of stage I-III disease. All staging is via the American Joint Committee on Cancer (AJCC)/International Association for the Study of Lung Cancer (IASLC) 8th edition staging criteria
* Patient must have 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. Test results originating from a Clinical Laboratory Improvement Act (CLIA)-certified or similarly accredited laboratory are acceptable; no specific assay is mandated. Plasma, cytology, or tumor tissue can be utilized for mutation testing
* Patient must not have received any prior treatment with an anti-VEGF agent

  * NOTE: 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
* Patients that have received prior radiation therapy are eligible. Radiation (limited field stereotactic radiation or conventional radiation) must have been completed at least one week prior to study drug initiation and more extensive field radiation (i.e., whole-brain radiotherapy \[WBRT\]) must have been completed at least two weeks prior to drug initiation
* Patient must not have any risk factors for anti-VEGF administration, specifically, hemoptysis, active cardiovascular disease, uncontrolled hypertension, significant proteinuria (screening urinalysis \> 300 mg/dl) and tumor invading major blood vessels
* Patient must have measurable disease. Baseline measurements of sites of disease must be obtained within 4 weeks prior to study randomization. If a potential target lesion is previously irradiated without subsequent growth and/or is radiated after the imaging from which baseline measurements are obtained, they cannot be included as target lesions, and additional target lesions are required to meet criteria for measurable disease
* Patient must not have had any prior systemic treatment for metastatic disease
* Patient must be ≥ 18 years of age
* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used
* All females of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy
* A female of childbearing potential is defined as any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
* Patient of childbearing potential and sexually active males must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for 2 weeks prior to the start of treatment, while on study treatment, and for

  * 6 weeks after the last dose of protocol treatment for female patients on the osimertinib (AZD9291) alone arm
  * 4 months after the last dose of protocol treatment for male patients on osimertinib (AZD9291) alone arm
  * 6 months after the last dose of protocol treatment for all patients on osimertinib (AZD9291) plus bevacizumab combination arm
  * NOTE: Female patients should also not breastfeed while on treatment and for 6 months after the last dose bevacizumab
* 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)
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional ULN (obtained =\< 14 days prior to randomization)
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
* Patients with treated brain metastases are eligible if neurologically stable without glucocorticoid therapy after the stated washout period from radiation therapy (RT) or surgery provided the metastatic lesions are non-hemorrhagic
* Patients with untreated brain metastases or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required provided the metastatic lesions are non-hemorrhagic and are neurologically stable without glucocorticoid therapy
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
* Patients with known history or current symptoms of cardiac disease, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
* Patient must have the ability to understand and the willingness to sign a written informed consent document and comply with study requirements
* Patient must not have had treatment with any investigational drug within five half-lives or 3 months (whichever is greater), prior to study initiation
* Patient must not be currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers of CYP3A4. For any patient currently receiving such inducers of CYP3A4, they must discontinue use prior to first dose of study treatment. All patients must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known inducer effects on CYP3A4
* Patient must not have any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of randomization, with the exception of alopecia and grade 2 prior platinum-therapy-related neuropathy
* Patient must not have any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it challenging for the patient to participate in the study. Screening for chronic conditions is not required
* Patient must not have refractory nausea and vomiting, chronic gastrointestinal diseases, the inability to swallow the osimertinib tablets or previous significant bowel resection that would preclude adequate absorption of osimertinib
* Patient must not have a medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease
* Patient must not have a history of hypersensitivity to active or inactive excipients of osimertinib or drugs with a similar chemical structure or class to osimertinib
* Patient must not have mean resting corrected QT interval (QTc) \> 470 msec obtained from 3 electrocardiograms (ECGs), using the screening clinic ECG machine derived QTc value (using Bazett's correction)
* Patient must not have any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g. complete left bundle branch block, third degree heart block and second-degree heart block
* Patient must not have any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, electrolyte abnormalities (including: potassium \< lower limit of normal \[LLN\]; magnesium \< LLN; calcium \< LLN), congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval and cause torsades de pointes

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(603)

  • Anchorage Associates in Radiation Medicine

    Anchorage, Alaska, United States

    Suspended

  • Anchorage Radiation Therapy Center

    Anchorage, Alaska, United States

    Suspended

  • Alaska Breast Care and Surgery LLC

    Anchorage, Alaska, United States

    Suspended

  • Alaska Oncology and Hematology LLC

    Anchorage, Alaska, United States

    Recruiting

  • Alaska Women's Cancer Care

    Anchorage, Alaska, United States

    Suspended

  • Anchorage Oncology Centre

    Anchorage, Alaska, United States

    Suspended

  • Katmai Oncology Group

    Anchorage, Alaska, United States

    Recruiting

  • Providence Alaska Medical Center

    Anchorage, Alaska, United States

    Suspended

  • Fairbanks Memorial Hospital

    Fairbanks, Alaska, United States

    Recruiting

  • Cancer Center at Saint Joseph's

    Phoenix, Arizona, United States

    Recruiting

  • Mercy Hospital Fort Smith

    Fort Smith, Arkansas, United States

    Suspended

  • CHI Saint Vincent Cancer Center Hot Springs

    Hot Springs, Arkansas, United States

    Suspended

  • NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

    Jonesboro, Arkansas, United States

    Recruiting

  • Kaiser Permanente-Deer Valley Medical Center

    Antioch, California, United States

    Recruiting

  • Mission Hope Medical Oncology - Arroyo Grande

    Arroyo Grande, California, United States

    Suspended

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center

    Burbank, California, United States

    Suspended

  • Kaiser Permanente Dublin

    Dublin, California, United States

    Recruiting

  • Kaiser Permanente-Fremont

    Fremont, California, United States

    Recruiting

  • Washington Health

    Fremont, California, United States

    Recruiting

  • Kaiser Permanente Fresno Orchard Plaza

    Fresno, California, United States

    Recruiting

  • Kaiser Permanente-Fresno

    Fresno, California, United States

    Recruiting

  • UC San Diego Moores Cancer Center

    La Jolla, California, United States

    Withdrawn

  • Kaiser Permanente- Modesto MOB II

    Modesto, California, United States

    Recruiting

  • Kaiser Permanente-Modesto

    Modesto, California, United States

    Recruiting

  • Kaiser Permanente-Oakland

    Oakland, California, United States

    Recruiting

  • Stanford Cancer Institute Palo Alto

    Palo Alto, California, United States

    Recruiting

  • Kaiser Permanente-Richmond

    Richmond, California, United States

    Recruiting

  • Kaiser Permanente-Roseville

    Roseville, California, United States

    Recruiting

  • Kaiser Permanente Downtown Commons

    Sacramento, California, United States

    Recruiting

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, United States

    Recruiting

  • Kaiser Permanente-South Sacramento

    Sacramento, California, United States

    Recruiting

  • Salinas Valley Memorial

    Salinas, California, United States

    Active, not recruiting

  • Kaiser Permanente-San Francisco

    San Francisco, California, United States

    Recruiting

  • Kaiser Permanente-Santa Teresa-San Jose

    San Jose, California, United States

    Recruiting

  • Kaiser Permanente San Leandro

    San Leandro, California, United States

    Recruiting

  • Pacific Central Coast Health Center-San Luis Obispo

    San Luis Obispo, California, United States

    Suspended

  • Kaiser San Rafael-Gallinas

    San Rafael, California, United States

    Recruiting

  • Kaiser Permanente Medical Center - Santa Clara

    Santa Clara, California, United States

    Recruiting

  • Mission Hope Medical Oncology - Santa Maria

    Santa Maria, California, United States

    Suspended

  • Kaiser Permanente-Santa Rosa

    Santa Rosa, California, United States

    Recruiting

  • Kaiser Permanente-South San Francisco

    South San Francisco, California, United States

    Recruiting

  • Kaiser Permanente-Stockton

    Stockton, California, United States

    Recruiting

  • Kaiser Permanente Medical Center-Vacaville

    Vacaville, California, United States

    Recruiting

  • Kaiser Permanente-Vallejo

    Vallejo, California, United States

    Recruiting

  • Kaiser Permanente-Walnut Creek

    Walnut Creek, California, United States

    Recruiting

  • Rocky Mountain Cancer Centers-Aurora

    Aurora, Colorado, United States

    Recruiting

  • The Medical Center of Aurora

    Aurora, Colorado, United States

    Suspended

  • Boulder Community Foothills Hospital

    Boulder, Colorado, United States

    Suspended

  • Rocky Mountain Cancer Centers-Boulder

    Boulder, Colorado, United States

    Recruiting

  • Rocky Mountain Cancer Centers - Centennial

    Centennial, Colorado, United States

    Suspended

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, United States

    Suspended

  • Rocky Mountain Cancer Centers-Penrose

    Colorado Springs, Colorado, United States

    Suspended

  • Kaiser Permanente-Franklin

    Denver, Colorado, United States

    Recruiting

  • The Women's Imaging Center

    Denver, Colorado, United States

    Suspended

  • AdventHealth Porter

    Denver, Colorado, United States

    Suspended

  • Colorado Blood Cancer Institute

    Denver, Colorado, United States

    Suspended

  • Presbyterian - Saint Lukes Medical Center - Health One

    Denver, Colorado, United States

    Suspended

  • Rocky Mountain Cancer Centers-Midtown

    Denver, Colorado, United States

    Suspended

  • Rocky Mountain Cancer Centers-Rose

    Denver, Colorado, United States

    Suspended

  • Rose Medical Center

    Denver, Colorado, United States

    Active, not recruiting

Showing 60 of 603 sites — filter to narrow it down. 323 of the 603 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT04181060. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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