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Monoclonal Antibodies
ATRA + Atezolizumab for Lung Cancer
Phase 1
Recruiting
Led By Dwight H Owen, MD
Research Sponsored by Dwight Owen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >= 18 years
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is to find out the best dose and side effects of ATRA and atezolizumab for treating patients with non-small cell lung cancer that has come back or has spread.
Who is the study for?
This trial is for adults with recurrent or metastatic non-small cell lung cancer who have tried standard treatments. They must be able to take oral medication, not have curable cancer options left, and agree to use birth control. People with certain health conditions, active autoimmune diseases, or untreated brain metastases can't join.Check my eligibility
What is being tested?
The trial tests the combination of ATRA (a vitamin A derivative) and atezolizumab (an immunotherapy drug) to find the best dose and monitor side effects in patients whose lung cancer has returned or spread.See study design
What are the potential side effects?
Possible side effects include immune system reactions that may affect organs, infusion-related reactions from atezolizumab, fatigue, digestive issues like nausea or diarrhea from ATRA, as well as potential blood abnormalities.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I am able to care for myself and perform daily activities.
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I can swallow and keep down pills.
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My lung cancer has returned or spread and cannot be cured.
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I had hepatitis C but have been treated and cured.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 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 (AEs)
Secondary outcome measures
Disease control rate
Overall response
Overall survival (OS)
+1 moreOther outcome measures
Effect of ATRA on the levels of myeloid-derived suppressor cells (MDSCs)
Side effects data
From 2009 Phase 4 trial • 163 Patients • NCT0083519810%
Cold
5%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tretinoin Gel 0.025%
Dapsone Gel 5% and Tretinoin Gel 0.025%
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (tretinoin, atezolizumab)Experimental Treatment2 Interventions
Patients receive tretinoin PO on days 1-3 of cycles 1-3. Patients also receive atezolizumab IV 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
Atezolizumab
2017
Completed Phase 3
~5860
Tretinoin
2013
Completed Phase 4
~2040
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
All-trans retinoic acid (ATRA) promotes cell growth and development, helping to differentiate cancer cells into more normal cells, potentially reducing their malignancy. Atezolizumab, a monoclonal antibody, targets PD-L1, a protein that tumors use to evade the immune system.
By blocking PD-L1, Atezolizumab enhances the body's immune response against cancer cells. This combination aims to normalize cancer cell behavior and boost the immune system's ability to fight the cancer, which is crucial for improving patient outcomes.
Integrated microbiome, metabolome, and proteome analysis identifies a novel interplay among commensal bacteria, metabolites and candidate targets in non-small cell lung cancer.
Integrated microbiome, metabolome, and proteome analysis identifies a novel interplay among commensal bacteria, metabolites and candidate targets in non-small cell lung cancer.
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Who is running the clinical trial?
Dwight OwenLead Sponsor
4 Previous Clinical Trials
171 Total Patients Enrolled
Dwight H Owen, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
1 Previous Clinical Trials
30 Total Patients Enrolled
Dwight H Owen, MD, MS, FACPPrincipal InvestigatorOhio State University Comprehensive Cancer Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am using two birth control methods or am not having sex to avoid pregnancy during and 5 months after the study.I agree to use contraception and not donate sperm for 7 months after my last treatment dose.I have severe liver disease with complications like confusion or fluid in my abdomen.I agree to use birth control during and for 4 months after the study.I have received all approved treatments for my specific cancer mutation.Your blood and body chemistry should be within certain normal levels.I have undergone standard chemotherapy or immunotherapy for my condition.You are expected to live for at least 3 more months.I have treated brain metastases and have been stable without steroids for at least 2 weeks.I have an autoimmune disease treated with strong medication in the last 2 years.Your disease can be measured using a specific set of guidelines called RECIST 1.1.I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.I am 18 years old or older.I had severe side effects from previous immunotherapy.I am able to care for myself and perform daily activities.I can swallow and keep down pills.I have had side effects in my brain, eyes, or heart from immunotherapy.My lung cancer has returned or spread and cannot be cured.I am HIV-positive, on treatment, and my viral load is undetectable.I had hepatitis C but have been treated and cured.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (tretinoin, atezolizumab)
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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