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New treatment option for Advanced Lung Non-Small Cell Carcinoma
Official title Testing Osimertinib as a Treatment for Lung Cancers With an EGFR Exon 20 Change
ClinicalTrials.gov ID: NCT03191149
What this study is testing
What is Osimertinib?
Osimertinib is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for advanced lung non-small cell carcinoma.
Also referred to as AZD 9291, AZD-9291.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase II trial studies how well osimertinib works in treating patients with non-small cell lung cancer with EGFR exon 20 insertion mutation that is stage IIIB-IV or has come back after a period of improvement (recurrent). Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 5 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants must have a pathologically-confirmed diagnosis of non-small cell lung cancer (NSCLC)
- Participants must have advanced disease - either stage IV disease, stage IIIB disease not amenable to definitive multi-modality therapy, or recurrent...
- An EGFR exon 20 insertion mutation must be detected in the tumor tissue. Patients may be enrolled in the study based on an exon 20 insertion EGFR...
- NOTE: Testing results are to be submitted via Medidata Rave and the study chair or delegate will review the reports
- Patients must have measurable disease; baseline measurements and ALL sites of disease must be obtained within 4 weeks to registration
See the full eligibility criteria
Who can join
- Participants must have a pathologically-confirmed diagnosis of non-small cell lung cancer (NSCLC)
- Participants must have advanced disease - 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...
- An EGFR exon 20 insertion mutation must be detected in the tumor tissue. Patients may be enrolled in the study based on an exon 20 insertion EGFR mutation detected by any Clinical Laboratory Improvement Act...
- NOTE: Testing results are to be submitted via Medidata Rave and the study chair or delegate will review the reports
- Patients must have measurable disease; baseline measurements and ALL sites of disease must be obtained within 4 weeks to registration
- Patients must have previously received at least one line of therapy for their advanced lung cancer; there are no restrictions on the maximum number of prior therapies allowed
- Participants must not have previously received osimertinib
- Participants must have not previously received therapies targeting PDL1, PD1 or CTLA4 within 6 months (180 days) prior to registration
- Age \>= 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 1
- Hemoglobin \>= 9.0 g/L (within 4 weeks before registration)
- Leukocytes/white blood cells \>= 3,000/mcL (within 4 weeks before registration)
- Absolute neutrophil count \>= 1,500/mcL (within 4 weeks before registration)
- Platelets \>= 100,000/mcL (within 4 weeks before registration)
- Total bilirubin =\< 1.5 x upper limit of normal (ULN) if no liver metastases or =\< 3 times ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases (within 4 weeks...
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =\< 3 x institutional upper limit of normal; for patients...
- Creatinine =\< 1.5 x institutional upper limit of normal (within 4 weeks before registration)
- Participants may not have clinically active or symptomatic interstitial lung disease or interstitial pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention), or a history of...
- Participants may not have had radiation to the lung fields within four weeks (28 days) of starting treatment. For patients receiving palliative radiation to thoracic vertebrae, ribs or other sites where the radiation...
- Participants may not have clinically symptomatic brain metastases, leptomeningeal disease, or spinal cord compression. Patients may be on a stable dose of corticosteroids to control brain metastases if they have been on...
- Patients must have an ECHO or a nuclear study (MUGA or first pass) within 4 weeks (28 days) prior to registration to treatment and must not have a left ventricular ejection fraction (LVEF) \ = 50% for the patient to be...
- Participants may not have any of the following cardiac criteria:
- Mean resting corrected QT interval (QTc) \>= 470 msec obtained from 3 electrocardiograms (ECGs) using the screening clinic ECG machine-derived QTc value
- No history of QT prolongation associated with other medications that required discontinuation of that medication
- Patient must not be receiving any concomitant medications that are known to be associated with Torsades de Pointes
- Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g., complete left bundle branch block, third degree heart block, second degree heart block, any factors that increase the risk...
- Symptomatic heart failure - New York Heart Association (NYHA) grade II-IV
- Participants may not have a second, clinically active, cancer. Patients with second cancers which have been treated with curative intent and/or are currently inactive are allowed
- Participants may not be receiving any other investigational agents. Patients previously treated with investigational agents must complete a washout period of at least two weeks or five half-lives, whichever is longer...
- Participants may not have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric...
- Patients must have no history of hypersensitivity active or inactive excipients of osimertinib (AZD9291) or drugs with a similar chemical structure or class to osimertinib (AZD9291)
- Patients must not currently be receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inducers of CYP3A4 (at least 3 week prior). All...
- If medically feasible, patients taking regular medication, with the exception of potent inducers of CYP3A4, should be maintained on it throughout the study period. Patients taking concomitant medications whose...
- NOTE: Use of St John's wort is a contra-indication for osimertinib (AZD9291) use
- If applicable, it is recommended that the starting and maintenance dose of rosuvastatin (due to BCRP inhibition by AZD9291 [osimertinib]) should be as low as possible and should be guided by the statin label. Monitoring...
- people taking warfarin should be monitored regularly for changes in prothrombin time or international normalized ratio (INR)
- No unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment, with the exception of alopecia and grade 2, prior...
- Patients with refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of osimertinib...
- Women must not be pregnant or breast-feeding because osimertinib (AZD9291) has been shown to cause fetal harm in animal models. All females of childbearing potential must have a blood test or urine study within 2 weeks...
- Women of childbearing potential (WOCBP) and sexually active males must use an accepted and effective method of contraception while receiving protocol treatment or abstain from sexual intercourse for the duration of...
- Other anticancer agents and investigational agents should not be given while the subject is on study treatment
- Supportive care and other medications that are considered necessary for the subject's wellbeing may be given at the discretion of the investigator
- A guidance regarding potential interactions with concomitant medications is provided
The study team makes the final eligibility decision.
Where it's taking place
- Anchorage, Alaska, United States
- Fairbanks, Alaska, United States
- Fort Smith, Arkansas, United States
- Little Rock, Arkansas, United States
- Burbank, California, United States
- Washington D.C., District of Columbia, United States
- Fort Lauderdale, Florida, United States
- Atlanta, Georgia, United States
- Boise, Idaho, United States
- Caldwell, Idaho, United States
- Coeur d'Alene, Idaho, United States
- Emmett, Idaho, United States
- Fruitland, Idaho, United States
- Meridian, Idaho, United States
- Nampa, Idaho, United States
- Post Falls, Idaho, United States
- Sandpoint, Idaho, United States
- Twin Falls, Idaho, United States
- Alton, Illinois, United States
- Aurora, Illinois, United States
+ 222 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Anchorage, Alaska, United States; Fairbanks, Alaska, United States; Fort Smith, Arkansas, United States; Little Rock, Arkansas, United States; Burbank, California, United States; Washington D.C., District of Columbia, United States and 236 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.