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Cabozantinib + Pembrolizumab for Lung Cancer (LUNG-IST-127 Trial)
Phase 2
Recruiting
Research Sponsored by University of Illinois at Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 19 months
Awards & highlights
Summary
This trial assesses combo therapy of cabozantinib and pembrolizumab to treat metastatic squamous NSCLC after induction with pembrolizumab, carboplatin and nab/paclitaxel. It looks at efficacy, safety and quality of life.
Who is the study for?
Adults with metastatic squamous Non-Small Cell Lung Cancer who've had prior treatment without disease progression. They must be in good health otherwise, understand the study and consent to it, use contraception, and have no other active cancers or severe allergies to trial drugs.
What is being tested?
The effectiveness of Cabozantinib combined with Pembrolizumab as a maintenance therapy for lung cancer patients post-induction therapy is being tested. The goal is to see how well these drugs work together after initial chemotherapy.
What are the potential side effects?
Possible side effects include fatigue, digestive issues like nausea or diarrhea, skin reactions, increased blood pressure, liver enzyme changes, and potential risk of bleeding or clotting disorders.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 19 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~19 months
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
Adverse events as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) v5
HRQoL using European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Overall Response Rate (ORR)
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: SingleExperimental Treatment3 Interventions
All subjects will receive carbozantinib 40mg PO once daily Days 1-21 Q3W and pembrolizumab 200mg IV infusion Q3W or 400mg IV infusion Q6W per the treating physician's discretion as maintenance therapy following 4 cycles of induction therapy with disease control
Note: Cabozantinib should be stopped at least 3 weeks prior to elective surgery. Do not administer cabozantinib for at least 2 weeks after major surgery and until complete wound healing.
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Who is running the clinical trial?
University of Illinois at ChicagoLead Sponsor
632 Previous Clinical Trials
1,567,390 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My recent tests show my organs are functioning well.I haven't had radiation for bone metastasis in the last 2 weeks or any radiation in the last 4 weeks.I haven't taken any kinase inhibitor medication in the last 2 weeks.I haven't had any cancer treatment in the last 4 weeks.I have been treated with cabozantinib before.My cancer has spread to or is surrounding major blood vessels.My cancer has a specific genetic change that can be treated with approved drugs.I have recovered from previous treatment side effects, or they are minor and stable.I am mentally and physically capable of participating in a clinical trial.My lung cancer is confirmed to be squamous non-small cell type.I will use birth control during and for 4 months after my treatment ends.I have stage IV non-small cell lung cancer and haven't been treated for it yet.My tumor has been tested for PD-L1.I am not pregnant, and if I can have children, I've had a negative pregnancy test recently.I am currently on medication for an infection.I am 18 years old or older.I have lung issues seen on scans, or known airway disease, and no new or worsening cavities in my lungs if on maintenance therapy.I understand and agree to follow the study's requirements.I have been active and mostly self-sufficient in the last 28 days.I do not have any severe illnesses that would make it unsafe for me to join the study.My cancer did not worsen after initial treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Single
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.
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