Osimertinib With or Without Bevacizumab as Initial Treatment for Patients With EGFR-Mutant Lung Cancer
Launched by NATIONAL CANCER INSTITUTE (NCI) · Nov 27, 2019
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effects of two treatments for patients with advanced non-small cell lung cancer that has a specific gene change called an EGFR mutation. Researchers want to find out if combining two medications, osimertinib and bevacizumab, can help control the cancer better than using osimertinib alone. Osimertinib works by blocking a protein that helps cancer cells grow, while bevacizumab may stop tumors from getting the blood supply they need to grow and spread. The goal is to see if this combination can help patients live longer and manage their cancer more effectively.
To participate in this trial, patients must have a confirmed diagnosis of non-small cell lung cancer with an EGFR mutation, and their disease must be advanced or recurrent. They should not have received certain prior treatments, including any anti-VEGF medications. Eligible patients will be closely monitored during the trial and will receive either the combination treatment or osimertinib alone. It's important for potential participants to discuss any questions or concerns with their healthcare team to ensure they understand what being part of the study entails and to determine if they qualify.
Gender
ALL
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
About National Cancer Institute (Nci)
The National Cancer Institute (NCI) is a prominent component of the National Institutes of Health (NIH), dedicated to advancing cancer research and improving patient outcomes through innovative clinical trials. As a leading sponsor of cancer-related studies, NCI focuses on facilitating the development of new therapies, enhancing prevention strategies, and understanding the biology of cancer. The institute collaborates with academic institutions, healthcare providers, and industry partners to conduct rigorous clinical trials that aim to translate scientific discoveries into effective treatments. NCI’s commitment to fostering a robust research environment supports the mission to eliminate cancer as a major health problem.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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Nassau Bay, Texas, United States
Richardson, Texas, United States
The Woodlands, Texas, United States
Paramus, New Jersey, United States
Glastonbury, Connecticut, United States
Neenah, Wisconsin, United States
New London, Wisconsin, United States
Shawano, Wisconsin, United States
Waupaca, Wisconsin, United States
Westerly, Rhode Island, United States
Missoula, Montana, United States
Oshkosh, Wisconsin, United States
Fargo, North Dakota, United States
Fargo, North Dakota, United States
Greeley, Colorado, United States
'Aiea, Hawaii, United States
Nampa, Idaho, United States
Alton, Illinois, United States
Springfield, Illinois, United States
Grand Island, Nebraska, United States
Toledo, Ohio, United States
Berlin, Wisconsin, United States
Avon, Ohio, United States
Des Moines, Iowa, United States
Kalispell, Montana, United States
Dallas, Texas, United States
West Islip, New York, United States
Troy, Ohio, United States
Nampa, Idaho, United States
Pontiac, Michigan, United States
Ann Arbor, Michigan, United States
Brighton, Michigan, United States
Chelsea, Michigan, United States
Dayton, Ohio, United States
Danville, Illinois, United States
Guilford, Connecticut, United States
Orland Park, Illinois, United States
Greenville, Ohio, United States
Boone, Iowa, United States
Fort Dodge, Iowa, United States
Jefferson, Iowa, United States
Marshalltown, Iowa, United States
Ames, Iowa, United States
Canton, Michigan, United States
Minocqua, Wisconsin, United States
Verona, New York, United States
Verona, New York, United States
Glenview, Illinois, United States
Grayslake, Illinois, United States
Ankeny, Iowa, United States
Sunset Hills, Missouri, United States
Marysville, Ohio, United States
Des Moines, Iowa, United States
Clive, Iowa, United States
Lincoln, Nebraska, United States
Lansing, Michigan, United States
Loveland, Colorado, United States
Jefferson City, Missouri, United States
Pontiac, Michigan, United States
Kinston, North Carolina, United States
Ridgewood, New Jersey, United States
Hanover, Pennsylvania, United States
Silverdale, Washington, United States
Dayton, Ohio, United States
Dayton, Ohio, United States
Royal Oak, Michigan, United States
Sandpoint, Idaho, United States
Baker City, Oregon, United States
Ontario, Oregon, United States
Kenansville, North Carolina, United States
Richlands, North Carolina, United States
East Hills, New York, United States
Dearborn, Michigan, United States
Troy, Michigan, United States
North Wilkesboro, North Carolina, United States
Millville, Delaware, United States
Saginaw, Michigan, United States
Tawas City, Michigan, United States
Detroit, Michigan, United States
Grosse Pointe Woods, Michigan, United States
Grosse Pointe Woods, Michigan, United States
Macomb, Michigan, United States
Warren, Michigan, United States
Flint, Michigan, United States
Warren, Michigan, United States
East China Township, Michigan, United States
Macomb, Michigan, United States
Warren, Michigan, United States
Grosse Pointe Woods, Michigan, United States
Rochester Hills, Michigan, United States
Mount Vernon, Illinois, United States
Ankeny, Iowa, United States
Clive, Iowa, United States
Des Moines, Iowa, United States
Des Moines, Iowa, United States
Denver, Colorado, United States
Waukee, Iowa, United States
Rolla, Missouri, United States
Littleton, Colorado, United States
Parker, Colorado, United States
Cape Girardeau, Missouri, United States
Winchester, Massachusetts, United States
Patients applied
Trial Officials
Helena A Yu
Principal Investigator
ECOG-ACRIN Cancer Research Group
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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