11 Participants Needed

Erlotinib + Onalespib for Non-Small Cell Lung Cancer

Recruiting at 6 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: National Cancer Institute (NCI)
Must be taking: Erlotinib
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase I/II trial studies the side effects and best dose of onalespib lactate when given together with erlotinib hydrochloride and to see how well they work in treating patients with EGFR-mutant non-small cell lung cancer that has come back (recurrent) or has spread to other places in the body (metastatic). Erlotinib hydrochloride and onalespib lactate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Who Is on the Research Team?

Jonathan Wesley Riess, M.D., M.S. for ...

Jonathan W. Riess

Principal Investigator

City of Hope Comprehensive Cancer Center LAO

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I can take care of myself but might not be able to do heavy physical work.
Ability to understand and the willingness to sign a written informed consent document
My NSCLC with EGFR exon 20 mutation has worsened after chemotherapy.
See 19 more

Exclusion Criteria

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.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive erlotinib hydrochloride orally daily and onalespib lactate intravenously 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.

12 weeks
3 visits per cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year
Every 12 weeks for 1 year, then annually

What Are the Treatments Tested in This Trial?

Interventions

  • Erlotinib Hydrochloride
  • Onalespib Lactate
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Treatment (erlotinib hydrochloride, onalespib lactate)Experimental Treatment4 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+
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