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Chemotherapy
Atezolizumab for Small Cell Lung Cancer
Phase 2
Waitlist Available
Led By Jeffrey Clarke, MD
Research Sponsored by Jeffrey Clarke
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from c1d1 until death or up to a maximum of 9 months
Awards & highlights
Summary
This trial is testing a new treatment for people with small cell lung cancer that has spread to their brain. The treatment is a combination of drugs, including a new drug called atezolizumab. The trial will last for several months, and people will be treated until their cancer progresses or they have side effects that are too severe.
Eligible Conditions
- Small Cell Lung Cancer
- Brain Tumor
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from c1d1 until death or up to a maximum of 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from c1d1 until death or up to a maximum of 9 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Intracranial Progression Free Survival (iPFS)
Secondary outcome measures
Extracranial Progression Free Survival (PFS)
Overall Response Rate (ORR)
Overall Survival (OS)
+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%
Dyspnoea
19%
Cough
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%
Weight decreased
5%
Haemoptysis
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%
Lung infection
1%
Acute kidney injury
1%
Lower respiratory tract infection
1%
Respiratory tract infection
1%
Musculoskeletal chest pain
1%
Depression
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
1Treatment groups
Experimental Treatment
Group I: Study Treatment ArmExperimental Treatment3 Interventions
4 cycles of induction treatment with Atezolizumab (1200 mg on Day 1) combined with carboplatin (5-6 AUC on Day 1) and etoposide (80-100 mg/m2 on Days 1-3). After 4 cycles of induction treatment, subjects will receive atezolizumab maintenance 1200 mg on Day 1 of each 3-week cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6670
Etoposide
2010
Completed Phase 3
~2440
Atezolizumab
2017
Completed Phase 3
~5860
Find a Location
Who is running the clinical trial?
Jeffrey ClarkeLead Sponsor
3 Previous Clinical Trials
139 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,542 Previous Clinical Trials
568,074 Total Patients Enrolled
Duke UniversityOTHER
2,394 Previous Clinical Trials
3,059,483 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You can have used steroids before to prevent nausea and vomiting caused by chemotherapy.You have excessive fluid buildup around your lungs, heart, or abdomen that requires frequent drainage. If you have a catheter in place to manage this condition, you may still be eligible.You have had a bad reaction to atezolizumab or other drugs that help the immune system fight cancer.You have a history of autoimmune disease or immune deficiency, but exceptions are made for patients with certain conditions that are well-controlled with medication. However, if you have an autoimmune-related rash that covers more than 10% of your body, you will not be eligible. You cannot have received a live vaccine within four weeks prior to starting the study or anticipate needing one during the study or within five months after the last dose. You also cannot be pregnant or breastfeeding, and you cannot have received any experimental medications within 28 days prior to starting the study.If you have another type of cancer, you can still participate as long as it's not currently getting worse and doesn't need specific treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Study Treatment Arm
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.
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