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Tyrosine Kinase Inhibitor

Erlotinib + Cabozantinib for Non-Small Cell Lung Cancer

Phase 2

Waitlist Available

Led By Joel W Neal

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

Patients with tumor showing a sensitizing mutation in epidermal growth factor receptor (EGFR), as defined in the protocol

Eastern Cooperative Oncology Group (ECOG) performance status between 0-2

Must not have

Patients with known human immunodeficiency virus (HIV) disease taking antiretroviral therapy

Known chronic active hepatitis B

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry, up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the effectiveness of two drugs, either alone or in combination, as second or third line therapy for stage IV non-small cell lung cancer.

Who is the study for?

This trial is for adults with Stage IV non-small cell lung cancer who have a specific mutation in the EGFR gene, have received 1-2 prior chemotherapy treatments, and can swallow tablets. They should not have had certain previous cancer therapies or major health issues that could affect their participation.

What is being tested?

The study is testing how well erlotinib hydrochloride and cabozantinib-s-malate work alone or together as second or third line therapy for patients. These drugs block enzymes needed by tumor cells to grow, but it's unclear if combining them offers better results.

What are the potential side effects?

Potential side effects include diarrhea, rash, liver problems, fatigue, mouth sores, high blood pressure and hand-foot syndrome (redness and pain on palms/soles). There may also be risks of abnormal heart rhythm or bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My tumor has a specific change in the EGFR gene.

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I can take care of myself and am up and about more than half of my waking hours.

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I have enough cancer tissue samples for MET testing.

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My cancer has grown after at least 2 treatment rounds.

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I have had 1 or 2 rounds of chemotherapy.

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My lung cancer is at stage IV.

Exclusion Criteria

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

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I am HIV positive and on antiretroviral therapy.

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I have been diagnosed with chronic active hepatitis B.

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I am currently taking certain medications.

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I have had cancer within the last 2 years that needed or still needs treatment.

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I do not have any severe, uncontrolled illnesses.

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I have previously received treatments targeting specific cancer growth factors.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry, up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry, up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry, up to 5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Progression-free Survival (PFS)

Secondary study objectives

Overall Survival (OS)

Proportion of Patients With MET Positivity

Proportion of Patients With Objective Response

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

4Treatment groups

Experimental Treatment

Group I: Arm Z (erlotinib+cabozantinib; step II)Experimental Treatment3 Interventions

Patients achieving disease progression in Arm A or Arm B may receive erlotinib and cabozantinib as patients in Arm C. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm C (erlotinib+cabozantinib)Experimental Treatment3 Interventions

Patients receive erlotinib as patients in Arm A and cabozantinib as patients in Arm B. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group III: Arm B (cabozantinib)Experimental Treatment2 Interventions

Patients receive cabozantinib PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group IV: Arm A (erlotinib)Experimental Treatment2 Interventions

Patients receive erlotinib PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cabozantinib S-malate

2013

Completed Phase 2

~470