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

Must not be taking: CYP3A4 inducers, Proton pump inhibitors

Disqualifiers: Investigational agents, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 15

Duration: 12 weeks

11 Participants Needed

Trial Summary

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.

Research Team

Jonathan W. Riess

Principal Investigator

City of Hope Comprehensive Cancer Center LAO

Eligibility Criteria

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.

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Treatment (erlotinib hydrochloride, onalespib lactate) Experimental Treatment 4 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.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+