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Monoclonal Antibodies
Triple Therapy for Small Cell Lung Cancer
Phase 1 & 2
Recruiting
Led By Jonathan W Goldman
Research Sponsored by Jonsson Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male participants must use a condom when having sex with a pregnant woman or a woman of childbearing potential
Eastern Cooperative Oncology Group (ECOG) performance status of =< 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights
Study Summary
This trial is studying the best dose of temozolomide to give with niraparib and atezolizumab to treat patients with advanced solid tumors and extensive-stage small cell lung cancer.
Who is the study for?
This trial is for adults with advanced solid tumors or extensive-stage small cell lung cancer who've responded to first-line platinum chemotherapy. They must be in good physical condition, not pregnant, willing to use contraception, and have no serious health issues or recent cancer treatments. Certain blood counts and organ functions are required.Check my eligibility
What is being tested?
The study tests the combination of temozolomide (a chemo drug), niraparib (a PARP inhibitor that blocks DNA repair in cancer cells), and atezolizumab (an immunotherapy). It aims to find the best dose and see if this mix is more effective for patients with certain advanced cancers.See study design
What are the potential side effects?
Possible side effects include fatigue, nausea, low blood counts leading to increased infection risk or bleeding problems, liver function changes, kidney function changes, allergic reactions to drugs used in treatment. Specific side effects will vary by individual.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I will use a condom with partners who are pregnant or can become pregnant.
Select...
I am fully active or can carry out light work.
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My cancer type is approved for treatment with atezolizumab by the FDA.
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My kidney and liver tests are within normal limits.
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My cancer is advanced and cannot be cured with surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 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 (Phase II)
Recommended phase II dose of niraparib and temozolomide combination (Phase Ib)
Secondary outcome measures
Incidence of adverse events per Common Terminology Criteria for Adverse Events version 4.0
Objective response rate
Overall survival
Other outcome measures
Quality of life per Functional Assessment of Cancer Therapy - Lung questionnaire (FACT-L)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (temozolomide, niraparib, atezolizumab)Experimental Treatment5 Interventions
Patients receive temozolomide PO QD on days 1-5 and niraparib PO QD on days 1-28. Cycles repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive standard of care atezolizumab IV every 3 weeks in the absence of disease progression or unacceptable toxicity.
Group II: Arm B (atezolizumab)Active Control3 Interventions
Patients receive standard of care atezolizumab IV every 3 weeks in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Niraparib
2018
Completed Phase 4
~1540
Atezolizumab
2017
Completed Phase 3
~5860
Temozolomide
2010
Completed Phase 3
~1930
Find a Location
Who is running the clinical trial?
Translational Research in OncologyOTHER
21 Previous Clinical Trials
6,603 Total Patients Enrolled
Jonsson Comprehensive Cancer CenterLead Sponsor
360 Previous Clinical Trials
27,638 Total Patients Enrolled
Translational Research in Oncology-U.SUNKNOWN
1 Previous Clinical Trials
88 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I will use a condom with partners who are pregnant or can become pregnant.I've had a good response to platinum-based chemotherapy after 4-6 cycles.I can start the trial within 7 weeks after my last chemotherapy session.I can take pills and have no allergies to the study drugs.Your blood clotting tests show normal results.I am fully active or can carry out light work.I do not have serious health issues or recent major surgeries that could affect my participation.My cancer type is approved for treatment with atezolizumab by the FDA.I still experience side effects from past treatments, except for hair loss or acceptable lab results.I have an advanced cancer that cannot be cured, and specifically, I have extensive-stage small cell lung cancer for the Phase 2 study.Your blood counts show enough white blood cells, platelets, and hemoglobin to be in good health.My cancer has spread to my brain or its coverings and is getting worse.I have recently had cancer treatment or brain/chest radiation.My kidney and liver tests are within normal limits.My cancer is advanced and cannot be cured with surgery.You have recently used certain medications that stimulate blood cell production, are pregnant, cannot take a PD-1 or PD-L1 inhibitor, have previously received a PARP inhibitor, have not responded well to first-line chemotherapy, or are currently taking a maintenance drug for extensive stage small cell lung cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (temozolomide, niraparib, atezolizumab)
- Group 2: Arm B (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.
Small Cell Lung Cancer Patient Testimony for trial: Trial Name: NCT03830918 — Phase 1 & 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you provide information regarding any preexisting Quality-of-Life Assessment examinations?
"Currently, the field of Quality-of-Life Assessment has 646 clinical trials in progress; 106 of which are at Phase 3. Though Houston, Texas appears to host most studies for this area of research, there is an impressive 25,766 centres around the world conducting such assessments."
Answered by AI
What is the enrollment capacity of this clinical investigation?
"Affirmative. Clinical information hosted on clinicaltrials.gov demonstrates that this particular medical experiment is presently enrolling patients, with the initial posting date being 6th March 2019 and last edited on 2nd July 2022. 74 participants are expected to be recruited from a single centre for study participation."
Answered by AI
Are there still vacancies available for participation in this research endeavor?
"Per the information available on clinicaltrials.gov, this investigation is actively seeking participants; it was first posted in March of 2019 and its most recent update occurred on February 7th 2022."
Answered by AI
What maladies can Quality-of-Life Assessment be applied to?
"Quality-of-Life Assessment is often used to create and implement advance directives, but it may be useful for treating the symptoms of certain conditions like pharmacotherapy, small cell lung cancer (sclc), or disease progression."
Answered by AI
Is this an unprecedented research endeavor?
"Since its initial clinical trial in 2002, sponsored by Schering-Plough with 60 participants, Quality-of-Life Assessment has seen a great deal of research activity. After being approved for Phase 2 trials, 646 live studies are now conducted across 1935 cities and 76 countries."
Answered by AI
Who else is applying?
What state do they live in?
Kentucky
What site did they apply to?
UCLA / Jonsson Comprehensive Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I 2as just diagnosed in December and have had no treatment I live in Kentucky and the small town I live in doesn't really have any really good doctors that actually care about about trying to cure or suppress the disease I'm willing to try anything to live a longer life I'm all alone and terrified and really don't know what to do.
PatientReceived no prior treatments
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