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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

Must not have

Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible

Abnormalities of the cornea based on history (e.g., dry eye syndrome, Sjogren's syndrome), congenital abnormality (e.g., Fuch's dystrophy), abnormal slit-lamp examination using a vital dye (e.g., fluorescein, Bengal Rose), and/or an abnormal corneal sensitivity test (Schirmer test or similar tear production test)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to at least 1 year

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not HIV-positive or not on antiretroviral therapy.

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I have a history of eye problems or tests show my cornea is not normal.

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

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I am not pregnant and will stop breastfeeding if treated with erlotinib and onalespib.

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I have been treated with an Hsp90 inhibitor before.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to at least 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With Dose Limiting Toxicities.

Number of Participants With at Least One Dose Limiting Toxicity (DLT)

Recommended Phase II Dose

Secondary study objectives

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 • NCT01664897

48%

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

Tumor Lysis Syndrome

Thromboembolic Event

Pleuritic Pain

Skin Infection

Oral Mucositis

Pain

Seizure

Blood and Lymphatic System disorder - other

Espohageal Ulcer

Hematoma

Hyperbilirubinemia

Hypotension

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Erlotinib Hydrochloride)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2900

0 / 11Eligibility criteria met