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Temozolomide + Atezolizumab for Small Cell Lung Cancer
Study Summary
This trial is studying the effects of temozolomide and atezolizumab as second line treatment for patients with small cell lung cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 3 trial • 1225 Patients • NCT02008227Trial Design
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- I do not have another cancer that could affect the trial's safety or results.I have been mostly active and able to carry out all pre-disease activities up to 28 days before signing up.I am a woman who can have children and I have a negative pregnancy test from the last two weeks.I am currently on medication for a serious infection.My cancer can be measured by scans as per RECIST v1.1.I agree to use contraception or remain abstinent.My small cell lung cancer has returned or worsened after treatment with platinum-based chemotherapy and immunotherapy.I can follow the study's procedures for its duration.I haven't had cancer treatments like chemotherapy or radiation in the last 2 weeks.I have not been in a clinical study or received study therapy in the last 4 weeks.I have a recent tissue sample from my tumor available for testing.I have brain metastases or carcinomatous meningitis but do not have symptoms.I have previously been treated with temozolomide.I have an autoimmune disease or immune deficiency, with some exceptions.I have not received a live vaccine in the last 4 weeks.I have a history of skin, lung, heart conditions, mental health or substance abuse issues.I have had no more than 2 treatments for my cancer after it spread.I have high calcium levels in my blood that are causing symptoms.I frequently need procedures to remove excess fluid from my chest or abdomen.Your recent lab test results must meet certain values within the last 28 days before joining the study.You are allergic to certain ingredients in the atezolizumab medication.You have had serious allergic reactions to certain treatments in the past.I have had cancer spread to the lining of my brain and spinal cord.I am 18 years old or older.I can swallow and keep down pills.You are expected to live for at least 3 more months.
- Group 1: Cohort I (atezolizumab, temozolomide)
- Group 2: Cohort II (atezolizumab, temozolomide)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
When was the last time Atezolizumab's FDA approval status was updated?
"Atezolizumab's safety is based on data from Phase 2 trials, which means that while there is evidence that it does not cause harm, its efficacy has yet to be proven."
What other research is similar to this project?
"There are many ongoing trials for Atezolizumab in a large number of cities and countries. The first study began 18 years ago and involved 60 people. This research was sponsored by Schering-Plough and completed Phase 2 approval in 2002. In the time since, 375 more studies have been undertaken."
Could you list any other instances where Atezolizumab has been tested?
"Atezolizumab was first studied in 2002 at the Memorial Sloan Kettering Cancer Center. Since then, there have been a completed 375 clinical trials worldwide. There are presently 570 actively recruiting clinical trials, with many of these trials running out of Madison, Wisconsin."
How many people total will be allowed to participate in this experiment?
"56 individuals that fit the pre-stated inclusionary conditions are needed to enroll in this study. Those who choose to participate can do so from multiple locations, such as University of Wisconsin in Madison, Wisconsin or Ohio State University Comprehensive Cancer Center in Columbus, Ohio."
Are there any available vacancies in this clinical trial for new participants?
"The most recent information available on clinicaltrials.gov suggests that this trial is still actively recruiting patients. The listing for this trial was first posted on January 26th, 2022 and has since been updated on October 26th, 2022."
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What portion of applicants met pre-screening criteria?
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