Your session is about to expire
← Back to Search
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
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My tumor has a specific change in the EGFR gene.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I have enough cancer tissue samples for MET testing.
Select...
My cancer has grown after at least 2 treatment rounds.
Select...
I have had 1 or 2 rounds of chemotherapy.
Select...
My lung cancer is at stage IV.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free Survival (PFS)
Secondary outcome measures
Overall Survival (OS)
Proportion of Patients With MET Positivity
Proportion of Patients With Objective Response
+1 moreSide effects data
From 2018 Phase 2 trial • 29 Patients • NCT0166489748%
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%
Pleuritic Pain
3%
Seizure
3%
Tumor Lysis Syndrome
3%
Skin Infection
3%
Thromboembolic Event
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
Erlotinib Hydrochloride
2010
Completed Phase 2
~2850
Cabozantinib S-malate
2013
Completed Phase 2
~470
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,028 Total Patients Enrolled
Joel W NealPrincipal InvestigatorECOG-ACRIN Cancer Research Group
2 Previous Clinical Trials
120 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am HIV positive and on antiretroviral therapy.I have been diagnosed with chronic active hepatitis B.I am currently taking certain medications.I do not have severe GI disorders that could lead to holes or abnormal connections.I haven't had cancer treatment or major surgery between the two steps, except for bone radiation that ended 2 weeks before Step 2.Your heart's electrical activity, measured by the QT interval, should be less than 500 milliseconds.I have not had a feeding tube placement in the last 3 months.I have had cancer within the last 2 years that needed or still needs treatment.Your disease can be measured using specific guidelines for evaluating tumor response.I have no recent serious heart conditions.I have a health condition that may not allow me to safely take erlotinib and cabozantinib together.My tumor has a specific change in the EGFR gene.My brain disease is stable and not getting worse.My lung cancer is confirmed to be non-small cell type, mostly not squamous.I can take care of myself and am up and about more than half of my waking hours.My blood, kidney, and liver tests are normal.I can swallow pills.I registered for the next phase within 4 weeks after my last treatment.I have recovered from previous treatment side effects, except for hair loss.You are expected to live for at least 3 more months.I have enough cancer tissue samples for MET testing.My cancer has grown after at least 2 treatment rounds.I have had a major blood clot in the past.I have had 1 or 2 rounds of chemotherapy.I have not had serious bleeding in my stomach, lungs, or other areas recently.You don't have enough tissue samples from your cancer for the study.I do not have any severe, uncontrolled illnesses.I have had radiation therapy recently.I have previously received treatments targeting specific cancer growth factors.My cancer has spread or is located in specific areas, confirmed by scans.My lung cancer is at stage IV.
Research Study Groups:
This trial has the following groups:- Group 1: Arm C (erlotinib+cabozantinib)
- Group 2: Arm Z (erlotinib+cabozantinib; step II)
- Group 3: Arm A (erlotinib)
- Group 4: Arm B (cabozantinib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Erlotinib Hydrochloride been authorized by the FDA?
"Erlotinib Hydrochloride was given a score of 2 on the safety scale, as this clinical trial is in its second phase and only has partial data to support its safety but none that promotes efficacy."
Answered by AI
How many participants are partaking in this investigation?
"Unfortunately, this research trial is no longer recruiting patients. It was posted on February 13th 2013 and the last update to its data occurred November 16th 2022. However, those seeking alternative studies have 1,363 other trials actively enrolling for non-small cell lung cancer and 154 clinical trials open for Erlotinib Hydrochloride participants."
Answered by AI
What data has been collected about Erlotinib Hydrochloride through prior research endeavors?
"Erlotinib Hydrochloride was originally trialed in 2002 at Mayo Clinic, Rochester. Since then, 1024 clinical trials have been conducted and finalized with an additional 154 still active studies; the most concentrated efforts are being done out of Plymouth, Iowa."
Answered by AI
Is the opportunity for participation in this research study still available to interested parties?
"Upon inspection of the clinicaltrials.gov database, this trial is not presently enrolling any additional patients. The study was initially posted in February 2013 and last updated on November 16th 2022; however, there are an abundance of other trials currently recruiting participants."
Answered by AI
To what extent is this investigation being implemented in various locales?
"This trial has over 100 available locations, such as Michiana Hematology Oncology PC-Plymouth in Plymouth,Michiana Hematology Oncology PC-South Bend in South Bend and Michiana Hematology Oncology PC-Westville in Westville amongst many others."
Answered by AI
What diseases is Erlotinib Hydrochloride commonly employed to treat?
"Erlotinib Hydrochloride is commonly used to battle malignant neoplasms, but it has also been employed to address pancreatic carcinoma, chemotherapy-induced disease progression and high risk patients."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger