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Monoclonal Antibodies
Combination Therapy for Non-Small Cell Lung Cancer
Phase 1
Waitlist Available
Led By Yasir Y Elamin, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ability to swallow and retain oral medications
Serum creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) >= 60 mL/minute for subjects with creatinine levels > 1.5 x the institutional ULN
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1.5 years
Awards & highlights
Study Summary
This triallooks at a new drug and 3 others to see if they can help treat lung cancer.
Who is the study for?
Adults with ALK-positive non-small cell lung cancer at stage IIIC, IV, or recurrent who can swallow pills and have a life expectancy of over 12 weeks. They may be treatment-naive or have had prior treatments but must meet specific blood count and organ function criteria. Pregnant women, those with recent serious heart issues, other cancers within 2 years (except certain skin/cervical cancers), active infections, or severe medical conditions are excluded.Check my eligibility
What is being tested?
The trial is testing the combination of Ensartinib (a growth-blocking enzyme inhibitor) with Carboplatin and Pemetrexed (chemotherapy drugs), plus Bevacizumab (a monoclonal antibody that hinders tumor spread). The goal is to find the optimal dose of Ensartinib and assess its effectiveness alongside these drugs in controlling advanced lung cancer.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system activation such as inflammation in various organs, infusion-related responses like fever or chills, fatigue from chemotherapy agents, possible bleeding due to Bevacizumab's effect on blood vessels, liver function changes from enzyme inhibitors, and general chemotherapy side effects like nausea.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can swallow and keep down pills.
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My kidney function, measured by creatinine or its clearance, is within the required range.
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I am fully active or can carry out light work.
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I am 18 years old or older.
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My cancer has an ALK rearrangement confirmed by a certified test.
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I have brain metastases but no symptoms, not on steroids, and any brain lesion is under 30mm.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Recommended phase 2 dose
Secondary outcome measures
Objective response rate
Overall survival
Progression-free survival
Other outcome measures
Biomarkers associated with response and resistance
Side effects data
From 2017 Phase 1 & 2 trial • 2 Patients • NCT02898116100%
Hypoalbuminaemia
50%
Eosinophilia
50%
Pulmonary oedema
50%
Dysgeusia
50%
Decreased appetite
50%
Hyponatraemia
50%
Nausea
50%
Arthralgia
50%
Blood alkaline phosphatase increased
50%
Insomnia
50%
Fatigue
50%
Lymphocyte count decreased
50%
Anaemia
50%
Hypocalcaemia
50%
Weight decreased
50%
Hypersensitivity
50%
Dyspnoea
50%
Cough
50%
Musculoskeletal pain
50%
Pyrexia
50%
Pleural effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ensartinib (200 mg)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (ensartinib, carboplatin, pemetrexed, bevacizumab)Experimental Treatment4 Interventions
INDUCTION THERAPY: Patients receive ensartinib PO QD on days 1-21, carboplatin IV over 15-60 minutes on day 1, pemetrexed IV over 10 minutes on day 1 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive ensartinib PO QD on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ensartinib
2017
Completed Phase 2
~50
Pemetrexed
2014
Completed Phase 3
~5250
Carboplatin
2014
Completed Phase 3
~6670
Bevacizumab
2013
Completed Phase 4
~5280
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,769 Total Patients Enrolled
Yasir Y Elamin, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
37 Total Patients Enrolled
Yasir Y ElaminPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
386 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to the dye used in the ensartinib 100 mg capsule.I haven't had cancer in the last 2 years, except for certain skin cancers, cervical cancers, or any cured cancer.I can swallow and keep down pills.I haven't had serious heart or stroke issues in the last 6 months.I have a serious heart condition.My blood clotting time is normal or managed if I'm on blood thinners.I do not have a serious infection, lung disease, or condition that would stop me from receiving the treatment.You are expected to live for at least 12 more weeks.I do not have a GI condition that affects medication absorption.My kidney function, measured by creatinine or its clearance, is within the required range.Your bilirubin levels in the blood should not be too high.I am fully active or can carry out light work.I will stop taking anticancer herbal medications before joining the study.I have not been treated or have progressed after ALK inhibitor treatment. I may have had platinum chemotherapy but finished it over a year ago, except for up to two cycles given while waiting for ALK test results without disease progression.You are at risk for a hole in your gastrointestinal (GI) tract.I am 18 years old or older.You have enough platelets in your blood, at least 100,000 per cubic millimeter.My liver enzymes are within the required range for the trial.My cancer has an ALK rearrangement confirmed by a certified test.I do not have cancer that has spread to the lining of my brain and spinal cord.I am not taking strong medication that affects liver enzymes.I am not pregnant or breastfeeding.Your hemoglobin level is at least 9 g/dL at the start of the study.I haven't had major surgery in the last 4 weeks or radiotherapy in the last 14 days.My lung cancer is at an advanced stage and cannot be treated with surgery or combined treatments.I haven't taken any experimental drugs in the last 21 days, or any side effects are mild.My blood clotting time is normal or managed with anticoagulants.Your body has enough infection-fighting white blood cells.I am a woman who can have children and I have a negative pregnancy test.I have brain metastases but no symptoms, not on steroids, and any brain lesion is under 30mm.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (ensartinib, carboplatin, pemetrexed, bevacizumab)
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.
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