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Erlotinib + Cabozantinib for Non-Small Cell Lung Cancer
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2018 Phase 2 trial • 29 Patients • NCT01664897Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Arm C (erlotinib+cabozantinib)
- Group 2: Arm Z (erlotinib+cabozantinib; step II)
- Group 3: Arm A (erlotinib)
- Group 4: Arm B (cabozantinib)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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."
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."
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."
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."
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."
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."
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