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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
Must not have
Prior or concurrent malignancy with potential to interfere with the safety or efficacy assessment of the investigational regimen
Clinically significant acute infection requiring systemic antibacterial, antifungal, or antiviral therapy
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

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.
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.
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 below
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My small cell lung cancer has returned or worsened after treatment with platinum-based chemotherapy and immunotherapy.
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I have had no more than 2 treatments for my cancer after it spread.
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I am 18 years old or older.
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I can swallow and keep down pills.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have another cancer that could affect the trial's safety or results.
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I am currently on medication for a serious infection.
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I haven't had cancer treatments like chemotherapy or radiation in the last 2 weeks.
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I have previously been treated with temozolomide.
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I have not received a live vaccine in the last 4 weeks.
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I have high calcium levels in my blood that are causing symptoms.
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I frequently need procedures to remove excess fluid from my chest or abdomen.
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I have had cancer spread to the lining of my brain and spinal cord.

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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Investigator-assessed objective response rate (ORR)
Secondary study objectives
Intracranial PFS
Overall survival
Progression free survival (PFS)
+1 more

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227
36%
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%
Stomatitis
11%
Vomiting
11%
Neuropathy peripheral
10%
Arthralgia
9%
Neutrophil count decreased
9%
Rash
8%
Headache
8%
Dysgeusia
8%
Paraesthesia
7%
Pain in extremity
7%
Mucosal inflammation
7%
Back pain
7%
Peripheral sensory neuropathy
7%
Insomnia
6%
Abdominal pain
6%
Febrile neutropenia
6%
Lacrimation increased
6%
Dry skin
6%
Pneumonia
6%
Dizziness
5%
Malaise
5%
Urinary tract infection
5%
Weight decreased
5%
Haemoptysis
5%
Nail disorder
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
4%
Productive cough
3%
Upper respiratory tract infection
3%
Pruritus
2%
Influenza like illness
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
1%
Syncope
1%
Dehydration
1%
Atrial fibrillation
1%
Lower respiratory tract infection
1%
Lung infection
1%
Respiratory tract infection
1%
Acute kidney injury
1%
Chronic obstructive pulmonary disease
1%
Pleural effusion
1%
Depression
1%
Musculoskeletal chest pain
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
Temozolomide
2010
Completed Phase 3
~1880
Atezolizumab
2017
Completed Phase 3
~5850

Find a Location

Who is running the clinical trial?

BayerIndustry Sponsor
2,260 Previous Clinical Trials
25,309,389 Total Patients Enrolled
Dwight OwenLead Sponsor
4 Previous Clinical Trials
133 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,550 Previous Clinical Trials
568,308 Total Patients Enrolled

Media Library

Atezolizumab Clinical Trial Eligibility Overview. Trial Name: NCT04919382 — Phase 2
Lung Cancer Research Study Groups: Cohort I (atezolizumab, temozolomide), Cohort II (atezolizumab, temozolomide)
Lung Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT04919382 — Phase 2
Atezolizumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT04919382 — Phase 2
~5 spots leftby Dec 2024
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