Your session is about to expire
← Back to Search
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
Age ≥ 18 years at the time of consent.
Subjects with histologically or cytologically confirmed squamous non-small cell lung cancer (sqNSCLC).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 19 months
Awards & highlights
LUNG-IST-127 Trial 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.Check my eligibility
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.See study design
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.
LUNG-IST-127 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My lung cancer is confirmed to be squamous non-small cell type.
LUNG-IST-127 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 19 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~19 months
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
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 moreLUNG-IST-127 Trial 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.
Find a Location
Who is running the clinical trial?
University of Illinois at ChicagoLead Sponsor
607 Previous Clinical Trials
1,559,030 Total Patients Enrolled
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA granted clearance to Single?
"Our team at Power rated the safety of Single a 2, as it is currently undergoing Phase 2 trials. This suggests that while there are preliminary data indicating its security, no evidence exists to confirm efficacy."
Answered by AI
Is participant recruitment for this trial currently underway?
"According to the information on clinicaltrials.gov, this research project is presently seeking participants; it was first uploaded on December 1st 2022 and has been updated most recently on December 12th 2022."
Answered by AI
How many individuals are currently taking part in this clinical experiment?
"Affirmative, the details available on clinicaltrials.gov indicate that this trial is actively looking for participants. It was initially posted on December 1st 2022 and its information has been revised as recently as December 12th 2022. The study intends to enrol 325 patients from one location."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger