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Monoclonal Antibodies

Combination Therapy for Non-Small Cell Lung Cancer

Phase 1
Waitlist Available
Led By Yasir Y Elamin
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
Must not have
The following within 6 months prior to cycle 1 day 1: Congestive heart failure, Arrhythmia or conduction abnormality requiring medication, Severe/unstable angina, coronary artery/peripheral bypass graft, or myocardial infarction, Cerebrovascular accident or transient ischemia
Clinically significant cardiovascular disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1.5 years
Awards & highlights

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't had serious heart or stroke issues in the last 6 months.
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I have a serious heart condition.
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I do not have a serious infection, lung disease, or condition that would stop me from receiving the treatment.
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I do not have a GI condition that affects medication absorption.
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I will stop taking anticancer herbal medications before joining the study.
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I do not have cancer that has spread to the lining of my brain and spinal cord.
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I am not taking strong medication that affects liver enzymes.
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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of adverse events
Recommended phase 2 dose
Secondary study objectives
Objective response rate
Overall survival
Progression-free survival
Other study objectives
Biomarkers associated with response and resistance

Side effects data

From 2017 Phase 1 & 2 trial • 2 Patients • NCT02898116
100%
Hypoalbuminaemia
50%
Fatigue
50%
Blood alkaline phosphatase increased
50%
Lymphocyte count decreased
50%
Anaemia
50%
Pulmonary oedema
50%
Eosinophilia
50%
Arthralgia
50%
Dysgeusia
50%
Weight decreased
50%
Hyponatraemia
50%
Hypocalcaemia
50%
Insomnia
50%
Nausea
50%
Decreased appetite
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
Carboplatin
2014
Completed Phase 3
~6120
Bevacizumab
2013
Completed Phase 4
~5540
Pemetrexed
2014
Completed Phase 3
~5550
Ensartinib
2017
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,039 Previous Clinical Trials
1,799,689 Total Patients Enrolled
Yasir Y ElaminPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
289 Total Patients Enrolled
Yasir Y Elamin, MDPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
205 Total Patients Enrolled

Media Library

Bevacizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04837716 — Phase 1
Lung Cancer Research Study Groups: Treatment (ensartinib, carboplatin, pemetrexed, bevacizumab)
Lung Cancer Clinical Trial 2023: Bevacizumab Highlights & Side Effects. Trial Name: NCT04837716 — Phase 1
Bevacizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04837716 — Phase 1
~6 spots leftby Sep 2027
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