Your session is about to expire
← Back to Search
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
Must not have
Progressive or symptomatic brain metastases, leptomeningeal disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights
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.
Select...
My cancer type is approved for treatment with atezolizumab by the FDA.
Select...
My kidney and liver tests are within normal limits.
Select...
My cancer is advanced and cannot be cured with surgery.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My cancer has spread to my brain or its coverings and is getting worse.
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
365 Previous Clinical Trials
27,874 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
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger