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Tyrosine Kinase Inhibitor
Erlotinib + Onalespib for Non-Small Cell Lung Cancer
Phase 1 & 2
Waitlist Available
Led By Jonathan W Riess
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
PHASE II COHORT B: Patients must have metastatic/recurrent histologically confirmed NSCLC that harbors an EGFR exon 20 insertion with progressive disease on or after platinum doublet chemotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to at least 1 year
Awards & highlights
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.
Who is the study for?
This trial is for adults with recurrent or metastatic non-small cell lung cancer that has certain EGFR mutations. They must have adequate organ function, not be on certain medications, and agree to use contraception. Excluded are those with uncontrolled illnesses, specific heart conditions, a history of severe drug reactions, or who are pregnant.Check my eligibility
What is being tested?
The trial tests the combination of Erlotinib Hydrochloride and Onalespib Lactate to see if they can stop tumor growth by blocking enzymes needed for cell growth. It includes lab biomarker analysis and pharmacological studies to determine the best dose and effectiveness.See study design
What are the potential side effects?
Potential side effects may include issues related to liver function, blood clotting problems, fatigue, gastrointestinal symptoms like nausea or diarrhea, skin rash due to erlotinib hydrochloride and possible visual disturbances.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself but might not be able to do heavy physical work.
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My NSCLC with EGFR exon 20 mutation has worsened after chemotherapy.
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My kidney function is normal or nearly normal.
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My NSCLC has specific EGFR mutations and has worsened despite treatment.
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My NSCLC has specific EGFR mutations and I've been on erlotinib for at least 12 weeks.
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I finished my last chemotherapy more than 3 weeks ago or radiotherapy more than 2 weeks ago.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to at least 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to at least 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With Dose Limiting Toxicities.
Number of Participants With at Least One Dose Limiting Toxicity (DLT)
Recommended Phase II Dose
Secondary outcome measures
Number of Subject With Overall Response
Number of Subject With Overall Response (Recommended Phase II Dose)
Progression-free Survival
Side effects data
From 2018 Phase 2 trial • 29 Patients • NCT0166489748%
Pneumonia
45%
Neutropenic Fever
38%
Shortness of breath
34%
Fatigue
34%
Diarrhea
31%
Lung Infection
28%
Nausea
24%
Rash
17%
Edema
17%
Muscle Aches
17%
Watery eyes
14%
Dizziness
10%
Sepsis
10%
Death
10%
Fever
3%
Pleuritic Pain
3%
Seizure
3%
Tumor Lysis Syndrome
3%
Skin Infection
3%
Thromboembolic Event
3%
Blood and Lymphatic System disorder - other
3%
Espohageal Ulcer
3%
Hematoma
3%
Hyperbilirubinemia
3%
Hypotension
3%
Oral Mucositis
3%
Pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Erlotinib Hydrochloride)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (erlotinib hydrochloride, onalespib lactate)Experimental Treatment4 Interventions
Patients receive erlotinib hydrochloride PO daily and onalespib lactate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Erlotinib Hydrochloride
2010
Completed Phase 2
~2850
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,142 Total Patients Enrolled
Jonathan W RiessPrincipal InvestigatorCity of Hope Comprehensive Cancer Center LAO
4 Previous Clinical Trials
323 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (erlotinib hydrochloride, onalespib lactate)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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