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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

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 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
3%
Thromboembolic Event
3%
Tumor Lysis Syndrome
3%
Pleuritic Pain
3%
Seizure
3%
Skin Infection
3%
Blood and Lymphatic System disorder - other
3%
Espohageal Ulcer
3%
Hematoma
3%
Hyperbilirubinemia
3%
Hypotension
3%
Oral Mucositis
3%
Pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Erlotinib Hydrochloride)

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
Erlotinib Hydrochloride
2010
Completed Phase 2
~2900

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,842 Previous Clinical Trials
41,002,875 Total Patients Enrolled
Joel W NealPrincipal InvestigatorECOG-ACRIN Cancer Research Group
2 Previous Clinical Trials
120 Total Patients Enrolled

Media Library

Cabozantinib S-malate (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01708954 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Arm Z (erlotinib+cabozantinib; step II), Arm C (erlotinib+cabozantinib), Arm A (erlotinib), Arm B (cabozantinib)
Non-Small Cell Lung Cancer Clinical Trial 2023: Cabozantinib S-malate Highlights & Side Effects. Trial Name: NCT01708954 — Phase 2
Cabozantinib S-malate (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01708954 — Phase 2
~10 spots leftby Sep 2025
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