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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
A concurrent diagnosis of a separate malignancy is allowed if clinically stable and does not require tumor-directed therapy.
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

Study 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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from c1d1 until death or up to a maximum of 9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from c1d1 until death or up to a maximum of 9 months for reporting.

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 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%
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%
Lower respiratory tract infection
1%
Acute kidney injury
1%
Depression
1%
Musculoskeletal chest pain
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: 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
2016
Completed Phase 3
~6040

Find a Location

Who is running the clinical trial?

Jeffrey ClarkeLead Sponsor
3 Previous Clinical Trials
139 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,538 Previous Clinical Trials
567,750 Total Patients Enrolled
Duke UniversityOTHER
2,356 Previous Clinical Trials
3,419,123 Total Patients Enrolled

Media Library

Carboplatin (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04610684 — Phase 2
Small Cell Lung Cancer Research Study Groups: Study Treatment Arm
Small Cell Lung Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT04610684 — Phase 2
Carboplatin (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04610684 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many distinct sites is this clinical experiment taking place?

"Currently, seven medical institutions are actively recruiting patients for this study; amongst them St. Vincent Anderson Regional Hospital in Anderson, City of Hope in Duarte and Nebraska Methodist Hospital in Omaha. Additionally, there are four other sites participating."

Answered by AI

Is there currently enrolment available for this investigation?

"Unfortunately, this clinical trial is no longer recruiting. It was initially posted on May 1st 2021 and last amended on October 10th 2022. If you are searching for additional studies, there are currently 2387 trials accepting patients with brain conditions and 1437 trails involving Atezolizumab that remain open to recruitment."

Answered by AI

Are there any historical precedents for the utilization of Atezolizumab in clinical trials?

"At this time, there are 1437 Atezolizumab-related investigations in progress with 352 taking place on Phase 3. Most of these studies are located in Shanghai but other areas have research sites as well, totaling 76634 locations."

Answered by AI

How many individuals are currently participating in this research project?

"At the moment, this study is not accepting any more patients. It was initially posted on May 1st 2021 and last modified on October 10th 2022. However, there are 2387 clinical trials for brain-related issues and 1437 studies involving Atezolizumab actively searching for participants if you're interested in alternative options."

Answered by AI

Has Atezolizumab been granted authorization from the FDA?

"Based on our assessment, Atezolizumab received a score of 2--indicating some data to support its safety but none backing its effectiveness. This is due to it being in the Phase 2 stage of testing."

Answered by AI

What medical condition is Atezolizumab traditionally employed to combat?

"The administration of Atezolizumab is a common pharmacotherapy for treating illnesses such as Hodgkin's disease, mesothelioma and advanced head/neck cancer."

Answered by AI
~1 spots leftby Apr 2025