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Monoclonal Antibodies
Atezolizumab for Small Cell Lung Cancer
Phase 1
Waitlist Available
Led By Ryan D Gentzler
Research Sponsored by National Cancer Institute (NCI)
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 up to 2 months
Awards & highlights
Study Summary
This trial is testing a combination of drugs to treat aggressive lung cancer that has spread. The drugs may stop the growth of tumor cells or help the body's immune system attack the cancer.
Eligible Conditions
- Extensive-stage Small Cell Lung Cancer
- Brain Metastasis
- Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants Experiencing Grade 3 and 4 Adverse Events
Number of Participants Who Received 3 or More Cycles of the Combination of Entinostat, Atezolizumab, Carboplatin, and Etoposide
Number of Participants With Dose Limiting Toxicities
Secondary outcome measures
Progression Free Survival (PFS) Rate
Side 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
1Treatment groups
Experimental Treatment
Group I: Treatment (carboplatin, etoposide, atezolizumab, entinostat)Experimental Treatment4 Interventions
INDUCTION THERAPY: Patients receive carboplatin IV over 30-60 minutes on day 1, etoposide IV over 60 minutes on days 1-3, atezolizumab IV over 30-60 minutes on day 1, and entinostat PO on days 1, 8, and 15. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive atezolizumab IV over 30 minutes on day 1 and entinostat PO on days 1, 8, and 15. Treatment repeats every 21 days for up to 13 cycles in the absence of disease progression or unacceptable toxicity.
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
Entinostat
2017
Completed Phase 2
~1170
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,657 Previous Clinical Trials
40,933,664 Total Patients Enrolled
Ryan D GentzlerPrincipal InvestigatorJHU Sidney Kimmel Comprehensive Cancer Center LAO
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are able to take care of yourself and do not need help with most daily activities.Your hemoglobin level is at least 9.0 grams per deciliter (g/dL).You have enough white blood cells called neutrophils in your body (counted as at least 1,500 per microliter).You are currently taking part in another clinical trial for an experimental drug.You have a mental health condition or personal circumstances that may make it difficult for you to follow the study requirements.You are taking bisphosphonate medication for high levels of calcium that are causing symptoms.You have a tissue sample available or are willing to undergo a new biopsy before starting treatment.If you have had cancer before, it should not interfere with the safety or effectiveness of the new treatment.You have had an allergic reaction to entinostat or other medicines used in this study in the past.You have a medical condition that is not under control.You are currently pregnant or breastfeeding.You have had a transplant using someone else's bone marrow or organ in the past.You are taking medication for which stopping is not possible and that affects the way etoposide works.You cannot have received a live vaccine within 4 weeks before the study or will need one during the study or up to 5 months after the last dose of atezolizumab.You have a history of autoimmune disease, unless it is an exception.If you had radiation treatment in the past, you must have completed it at least 7 days before joining the study. Stereotactic radiation therapy within 7 days is allowed.You have previously been treated with drugs that target the PD-1 or PD-L1 pathways.You are taking a medication called RANKL inhibitor (such as denosumab) which cannot be stopped before starting atezolizumab treatment.You have been diagnosed with extensive stage small cell lung cancer or other solid tumors that can be treated with carboplatin and etoposide.You haven't received any treatment for your advanced cancer that has spread to other parts of your body. If you had received treatment for cancer that was only in one area and it was over a year ago, you can still participate.If you have had brain metastases in the past and they are stable, and you are not currently taking corticosteroids to treat them, you may be eligible to participate.You have cancer that has spread to your brain, but it is not actively growing or requiring immediate treatment with steroids.You have a tumor that can be measured using a specific set of criteria, and this tumor should not be located in the brain or an area that has been treated with radiation before.You must have a recent tissue sample available from your current cancer diagnosis or be willing to undergo a new biopsy before starting the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (carboplatin, etoposide, atezolizumab, entinostat)
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.
Has the FDA given its stamp of approval to Atezolizumab?
"Considering the lack of clinical data on Atezolizumab, our team at Power have rated its safety as a 1. This is due to it only being in Phase 1 trials and having limited evidence for both efficacy and safety."
Answered by AI
How many sites have been chosen to provide access to this experiment?
"At the moment, this experiment is hosted at 5 sites around the country. These locations are situated in Pittsburgh, Madison and Salt Lake City with two other cities not mentioned here. To reduce travelling costs, we recommend that you join an outpost nearest to your location."
Answered by AI
Are recruitment efforts still underway for participants of this trial?
"Evidently, this medical study is not actively recruiting participants. Initially posted on February 1st 2021, the details of this trial have remained inert since July 16th 2022. Nevertheless, there are 3,861 other clinical trials presently seeking enrolment from patients."
Answered by AI
How many individuals have enrolled in this medical experiment thus far?
"Unfortunately, this particular research project is no longer welcoming participants. It was initially posted on February 1st 2021 and the last update happened July 16th 2022. However, if you're looking for other clinical trials, there are presently 2671 cancer studies that actively accept applicants as well as 1190 atezolizumab studies available to join."
Answered by AI
Are there any extant reports concerning Atezolizumab's efficacy?
"Currently, there are 1,190 active trials researching the efficacy of Atezolizumab and a third of those (320) have reached Phase 3. The global research network comprises 68,779 sites with many located in Shanghai."
Answered by AI
What therapeutic purposes does Atezolizumab mainly serve?
"Atezolizumab can be leveraged to address recurrent, advanced directives and cervical cancer in more progressive stages."
Answered by AI
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