Erlotinib + Onalespib for Non-Small Cell Lung Cancer

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two drugs, erlotinib (a targeted therapy) and onalespib (an experimental treatment), to evaluate their combined effectiveness in treating non-small cell lung cancer (NSCLC) with an EGFR mutation. The trial aims to determine the optimal dose of onalespib and assess any side effects. It targets individuals whose cancer has returned or spread after previous treatments. Suitable candidates have a history of NSCLC with specific genetic mutations and have experienced disease progression despite earlier therapies. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this experimental therapy.

Do I have to stop taking my current medications for the trial?

If you are currently taking erlotinib, you do not need to stop it before starting the trial. However, other similar medications must be stopped at least 7 days before starting the trial. Some medications that affect heart rhythm or interact with the trial drugs should be avoided, so discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that combining erlotinib hydrochloride with onalespib lactate has been studied for safety in patients with EGFR-mutant non-small cell lung cancer. Studies have found that this combination can cause side effects, but they are often manageable.

In earlier research, patients commonly experienced side effects like tiredness, nausea, and diarrhea, which were usually mild to moderate. More serious side effects were less common but did occur in some cases.

The current phase of the study suggests there is enough safety information to continue exploring these treatments. This indicates the combination is generally well-tolerated, though monitoring for side effects remains important. Always consult healthcare providers about potential risks and benefits before joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of erlotinib hydrochloride and onalespib lactate for non-small cell lung cancer because it offers a unique approach compared to standard treatments like chemotherapy and targeted monotherapies. Erlotinib is a targeted therapy that inhibits the epidermal growth factor receptor (EGFR), which is crucial for the growth of cancer cells. Onalespib, on the other hand, is an HSP90 inhibitor that disrupts multiple cancer-promoting pathways by destabilizing proteins required for tumor growth. This dual approach not only targets cancer cells more comprehensively but also has the potential to overcome resistance that often develops with current EGFR inhibitors alone.

What evidence suggests that erlotinib hydrochloride and onalespib lactate could be effective for non-small cell lung cancer?

Research has shown that combining erlotinib and onalespib may help treat EGFR-mutant non-small cell lung cancer (NSCLC). Erlotinib blocks proteins that promote cancer cell growth, while onalespib inhibits proteins essential for cancer cell survival and multiplication. Early studies suggest that these drugs together might effectively halt tumor growth. Participants in this trial will receive both erlotinib and onalespib as part of their treatment regimen. Overall, these treatments aim to prevent cancer from spreading by disrupting the processes necessary for cancer cells to thrive. ^{1 2 3 4 5}

Who Is on the Research Team?

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.

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 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?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34140248/

A California Cancer Consortium Phase I/II Trial (NCI 9878) This study sought to determine the safety and tolerability of onalespib plus erlotinib in EGFR-mutant NSCLC and to evaluate the preliminary efficacy of the ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02535338

Erlotinib Hydrochloride and Onalespib Lactate in Treating ... 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 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02535338?term=AREA%5BConditionSearch%5D(%22Lung%20Non-Small%20Cell%20Carcinoma%22)%20AND%20AREA%5BInterventionSearch%5D(%22Erlotinib%20Hydrochloride%22)&rank=9&tab=results

Erlotinib Hydrochloride and Onalespib Lactate in Treating ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9239707/

Erlotinib and Onalespib Lactate Focused on EGFR Exon 20 ... This study examined the safety and tolerability of erlotinib and the heat shock protein 90 inhibitor onalespib in EGFR-mutant non–small cell lung cancer ...

5. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2015-01411

Erlotinib Hydrochloride and Onalespib Lactate in Treating ... Erlotinib hydrochloride and onalespib lactate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Eligibility Criteria ...