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Erlotinib + Onalespib for Non-Small Cell Lung Cancer
Study Summary
This trial is testing a new drug, onalespib, to see if it can help treat lung cancer that has returned or spread. Onalespib works by blocking enzymes needed for cell growth.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2018 Phase 2 trial • 29 Patients • NCT01664897Trial Design
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Who is running the clinical trial?
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- I can take care of myself but might not be able to do heavy physical work.You are currently taking any other experimental medications.You have had allergic reactions to drugs similar to erlotinib and/or onalespib.Your heart's electrical activity, measured by the QT interval, is longer than normal when you are resting.Your heart's pumping ability is less than or equal to 50%, as shown by a heart ultrasound or special heart scan.I am not taking strong drugs that affect liver enzymes and will discuss any new meds with my doctor.My NSCLC with EGFR exon 20 mutation has worsened after chemotherapy.You have a disease that can be measured using a specific set of guidelines.Your platelet count is at least 100,000 per microliter.Your AST and ALT levels in the blood should not be more than 2.5 times the upper limit of normal at the study site.My kidney function is normal or nearly normal.Your blood clotting tests should be within a certain range.I had lung inflammation from an EGFR inhibitor but didn't need steroids.I am not taking any medications known to cause heart rhythm problems.I am not HIV-positive or not on antiretroviral therapy.I haven't taken proton pump inhibitors in the last 3 days and can schedule my medication as required.I have a history of eye problems or tests show my cornea is not normal.My NSCLC has specific EGFR mutations and has worsened despite treatment.My NSCLC has specific EGFR mutations and I've been on erlotinib for at least 12 weeks.I am currently taking erlotinib or will stop other EGFR-TKIs 7 days before starting the trial.I am currently taking erlotinib and my last dose was within the last 28 days.I have EGFR exon 20 insertions and may have been treated with erlotinib.I had brain metastases, but they've been treated, I have no symptoms, and I stopped taking steroids for it over a week ago.I have recovered from side effects of previous treatments, except for hair loss and mild nerve pain.You have a low level of white blood cells.I finished my last chemotherapy more than 3 weeks ago or radiotherapy more than 2 weeks ago.My EGFR mutation test was done in a certified lab.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I am not pregnant and will stop breastfeeding if treated with erlotinib and onalespib.I have been treated with an Hsp90 inhibitor before.You are expected to live for more than 3 months.You have enough infection-fighting white blood cells in your body.Your bilirubin level is within the normal range at the hospital.
- Group 1: Treatment (erlotinib hydrochloride, onalespib lactate)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the desired outcome of this research endeavor?
"This trial will measure the primary outcome, dose-limiting toxicities, over a period of 28 days from treatment commencement. Other outcomes to be monitored are progression-free survival (defined as time post first protocol treatment until death or disease progression according to RECIST v1.1 criteria), overall response (complete/partial responses) and PFS analysed using Kaplan Meier estimator."
What is Erlotinib Hydrochloride traditionally prescribed for?
"Erlotinib Hydrochloride is frequently prescribed to treat pancreatic metastatic cancer and in some cases, it can be utilized for treating treatment naive malignant neoplasms or primary pancreatic carcinoma."
How many individuals are participating in this medical investigation?
"Unfortunately, this clinical trial has ceased recruitment. It was initially posted on January 21st 2016 and its most recent edit occurred on September 20th 2022. There are currently 1363 trials recruiting patients with carcinoma non-small cell lung and 49 studies connected to Erlotinib Hydrochloride that are still open for participation."
Are participants currently being enrolled for this trial?
"This clinical trial is no longer taking on patients. It was first listed on the 21st of January 2016 and its last edit occurred on September 20th 2022. Currently, there are 1363 trials recruiting participants with carcinoma non-small cell lung cancer and 49 studies looking for patients to take Erlotinib Hydrochloride."
How many facilities have implemented this investigation?
"This clinical trial has 6 enrolment centres, including University of California Davis Comprehensive Cancer Center in Sacramento, USC / Norris Comprehensive Cancer Center in Los Angeles, and Los Angeles County-USC Medical Center in South Pasadena. Additionally, 3 other sites are actively recruiting patients for the study."
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