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New treatment option for Metastatic Non-small Cell Lung Cancer
Official title Osimertinib Alone or With Chemotherapy for EGFR-Mutant Lung Cancers
ClinicalTrials.gov ID: NCT04410796
What this study is testing
What is Osimertinib?
Osimertinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for metastatic non-small cell lung cancer.
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 study will compare the effectiveness of osimertinib alone with the combination of osimertinib and chemotherapy (carboplatin and pemetrexed) in people with metastatic lung cancer that has a change (mutation) in the gene EGFR. Osimertinib alone is the usual treatment for metastatic EGFR-mutant lung cancer.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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
- Inital
- Age ≥ 18 years
- Biopsy proven metastatic non-small cell lung cancer, confirmed at enrolling institution
- Somatic activating mutation in EGFR in pre-treatment tumor biopsy/ cytology from pleural fluid or cfDNA
- Either have not started a prior EGFR TKI therapy or may have started osimertinib within 3 weeks of confirming eligibility and enrollment criteria of...
You likely can't join if
- Initial
- Pregnant or lactating women
- Any radiotherapy within 1 week prior to starting treatment on protocol. The washout window only applies for patients who have not started Osimertinib.
- Any major surgery within 2 weeks of starting treatment on protocol. The washout window only applies for patients who have not started Osimertinib.
- Any evidence of clinically significant interstitial lung disease
- Treatment with an investigational drug within five half-lives of the compound or 3 months, whichever is greater
See the full eligibility criteria
Who can join
- Inital
- Age ≥ 18 years
- Biopsy proven metastatic non-small cell lung cancer, confirmed at enrolling institution
- Somatic activating mutation in EGFR in pre-treatment tumor biopsy/ cytology from pleural fluid or cfDNA
- Either have not started a prior EGFR TKI therapy or may have started osimertinib within 3 weeks of confirming eligibility and enrollment criteria of measurable disease per approval of PI, with no prior chemotherapy for...
- Measurable (RECIST 1.1) indicator lesion not previously irradiated with measurable disease determined per treating investigator. If a patient has already started on osimertinib there must be available pre-osimertinib...
- Karnofsky performance status (KPS)≥70%,
- Ability to swallow oral medications
- Adequate organ function (use of G-CSF and/or transfusion to meet these criteria are not allowed)
- Hemoglobin ≥ 9 g/dL
- Platelets ≥ 150,000mm\^3 or 150 x 10\^9/L
- AST, ALT ≤ 2.5 x ULN with no liver metastases or \< 5x ULN with the presence of liver metastases
- Total bilirubin ≤ 1.5 x ULN if no liver metastases or \< 3 x ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases
- Absolute neutrophil count (ANC) ≥ 1500 cells/mm\^3
- Creatinine ≤ ULN OR calculated creatinine clearance ≥ 60ml/min calculated by Cockcroft and Gault equation
- Creatinine clearance ≥ 60 mL/min calculated by Cockcroft and Gault equation
- Willing to use highly effective contraceptive measures if of child-bearing potential or if the patient's sexual partner is a woman of child-bearing potential:
- Female people should be using highly effective contraceptive measures, and must have a negative pregnancy test and not be breast-feeding prior to start of dosing through 6 weeks after discontinuing the study drug if of...
- Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments
- Women under 50 years old would be consider postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the post-menopausal range...
- Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation
- Male people should be willing to use barrier contraception and avoid sperm donation prior to the start of dosing through 4 months of discontinuing the study drug
What rules you out
- Initial
- Pregnant or lactating women
- Any radiotherapy within 1 week prior to starting treatment on protocol. The washout window only applies for patients who have not started Osimertinib.
- Any major surgery within 2 weeks of starting treatment on protocol. The washout window only applies for patients who have not started Osimertinib.
- Any evidence of clinically significant interstitial lung disease
- Treatment with an investigational drug within five half-lives of the compound or 3 months, whichever is greater
- Currently receiving (or unable to stop prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers of CYP3A4. All patients must try to avoid concomitant use of any...
- Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment, with the exception of alopecia and grade 2 prior platinum-therapy- related neuropathy
- Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the patient to participate in the...
- active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.
- Screening for chronic conditions is not required.
- In patients with resolved or chronic hepatitis B infection (inactive carrier state) or active controlled HBV infection on treatment with osimertinib
- Recommend monthly monitoring of ALT/AST, HBV DNA levels and HBsAg (if negative at baseline)
- Where liver signs and symptoms of viral reactivation appear (HBV DNA levels exceeding 10-fold from baseline or ≥100 IU/ml (if baseline HBV DNA levels are undetectable) or conversion of HBsAg negative to positive):
- Expert hepatologist/specialist oversight of the patient is required
- Consider interruption or discontinuation of study treatment, based on riskbenefit assessment
- Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the tablets or previous significant bowel resection that would preclude adequate absorption of osimertinib.
- Any of the following cardiac criteria:
- Mean resting corrected QT interval (QTc) \> 470 msec where QT interval is corrected for heart rate using Frederica's formula (QTcF).
- 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 with any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, electrolyte abnormalities (including: Serum/Plasma potassium \<LLN, Serum/Plasma Magnesium \<LLN...
- Past 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.
- History of hypersensitivity to active or inactive excipients of osimertinib or drugs with a similar chemical structure or class to osimertinib.
- Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements. Inclusion Criteria: Randomization
- Patients with detectable plasma EGFR mutations at C2D1
- Karnofsky performance status (KPS) ≥ 70%
- Adequate organ function
- Hemoglobin ≥ 9 g/dL
- Platelets ≥ 100,000mm\^3 or 100 x 10\^9/L
- Creatinine ≤ ULN OR calculated creatinine clearance ≥ 60ml/min
- AST, ALT ≤ 3x ULN with no liver metastases or ≤ 5x ULN with the presence of liver metastases
- Total bilirubin ≤ 1.5 x ULN if no liver metastases or ≤ 3 x ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases
- Absolute neutrophil count (ANC) ≥ 1500 cells/mm3Must have at least stable disease per RECIST 1.1 assessment prior to initiating chemotherapy at C4D1
- Eligibility testing (KPS, bloodwork) should be tested at C3D1. If the subject's evaluation does not meet eligibility criteria, any result obtained between C3 and C4 can be used Please note: All 'Initial' Exclusion...
The study team makes the final eligibility decision.
Where it's taking place
- Sacramento, California, United States
- San Francisco, California, United States
- Tampa, Florida, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Basking Ridge, New Jersey, United States
- Hackensack, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Seattle, Washington, United States
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to 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 Sacramento, California, United States; San Francisco, California, United States; Tampa, Florida, United States; Baltimore, Maryland, United States; Boston, Massachusetts, United States; Basking Ridge, New Jersey, United States and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.