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Temozolomide + Atezolizumab for Small Cell Lung Cancer
Phase 2
Recruiting
Led By Dwight H Owen
Research Sponsored by Dwight Owen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically or cytologically-documented diagnosis of extensive stage small cell lung cancer and progression or recurrence after platinum-based chemotherapy with immunotherapy
Maximum of 2 prior lines of systemic therapy allowed in the setting of metastatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from initiation of investigational therapy until the criteria for disease progression is met as defined by recist1.1 or death as a result of any cause, assessed up to 2 years
Awards & highlights
Study Summary
This trial is studying the effects of temozolomide and atezolizumab as second line treatment for patients with small cell lung cancer.
Who is the study for?
This trial is for adults with small cell lung cancer that has spread or returned after initial treatment. Participants must be able to take oral meds, have measurable disease, and a good performance status. They should not have had certain treatments recently and must agree to use contraception.Check my eligibility
What is being tested?
The study tests temozolomide (a chemotherapy drug) combined with atezolizumab (an immunotherapy antibody) as second or third line treatments in patients whose cancer has metastasized or recurred. The goal is to see if this combo can extend survival times.See study design
What are the potential side effects?
Possible side effects include typical chemotherapy-related issues like nausea, fatigue, hair loss, and increased risk of infection. Atezolizumab may cause immune system reactions leading to inflammation in various organs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My small cell lung cancer has returned or worsened after treatment with platinum-based chemotherapy and immunotherapy.
Select...
I have had no more than 2 treatments for my cancer after it spread.
Select...
I am 18 years old or older.
Select...
I can swallow and keep down pills.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from initiation of investigational therapy until the criteria for disease progression is met as defined by recist1.1 or death as a result of any cause, assessed up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from initiation of investigational therapy until the criteria for disease progression is met as defined by recist1.1 or death as a result of any cause, assessed 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
Investigator-assessed objective response rate (ORR)
Secondary outcome measures
Intracranial PFS
Overall survival
Progression free survival (PFS)
+1 moreSide effects data
From 2019 Phase 3 trial • 1225 Patients • NCT0200822736%
Fatigue
35%
Alopecia
24%
Diarrhoea
23%
Nausea
23%
Decreased appetite
22%
Anaemia
20%
Asthenia
19%
Cough
19%
Dyspnoea
16%
Myalgia
15%
Neutropenia
14%
Constipation
14%
Oedema peripheral
12%
Pyrexia
11%
Neuropathy peripheral
11%
Vomiting
11%
Stomatitis
10%
Arthralgia
9%
Rash
9%
Neutrophil count decreased
8%
Dysgeusia
8%
Paraesthesia
8%
Headache
7%
Pain in extremity
7%
Peripheral sensory neuropathy
7%
Insomnia
7%
Mucosal inflammation
7%
Back pain
6%
Pneumonia
6%
Febrile neutropenia
6%
Abdominal pain
6%
Dry skin
6%
Lacrimation increased
6%
Dizziness
5%
Haemoptysis
5%
Weight decreased
5%
Malaise
5%
Urinary tract infection
5%
Nail disorder
4%
Productive cough
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
3%
Pruritus
3%
Upper respiratory tract infection
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
2%
Influenza like illness
1%
Respiratory tract infection
1%
Musculoskeletal chest pain
1%
Lower respiratory tract infection
1%
Acute kidney injury
1%
Depression
1%
Lung infection
1%
Dehydration
1%
Chronic obstructive pulmonary disease
1%
Atrial fibrillation
1%
Syncope
1%
Pleural effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort II (atezolizumab, temozolomide)Experimental Treatment2 Interventions
Patients receive atezolizumab IV over 30-60 minutes on day 1. Patients also receive temozolomide PO QD on days 1-14 of cycle 1 and days 1-21 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group II: Cohort I (atezolizumab, temozolomide)Experimental Treatment2 Interventions
Patients receive atezolizumab IV over 30-60 minutes on day 1 and temozolomide PO QD on days 1-5. Cycles repeat every 28 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
Temozolomide
2010
Completed Phase 3
~1930
Find a Location
Who is running the clinical trial?
BayerIndustry Sponsor
2,238 Previous Clinical Trials
25,332,662 Total Patients Enrolled
Dwight OwenLead Sponsor
4 Previous Clinical Trials
133 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,540 Previous Clinical Trials
567,843 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort I (atezolizumab, temozolomide)
- Group 2: Cohort II (atezolizumab, temozolomide)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
Who else is applying?
What state do they live in?
Ohio
What site did they apply to?
Ohio State University Comprehensive Cancer Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
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