Chemotherapy and Atezolizumab for Patients With Extensive Stage Small Cell Lung Cancer (SCLC) With Untreated, Asymptomatic Brain Metastases
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|ClinicalTrials.gov Identifier: NCT04610684|
Recruitment Status : Recruiting
First Posted : October 30, 2020
Last Update Posted : September 13, 2022
|Condition or disease||Intervention/treatment||Phase|
|Small-cell Lung Cancer Brain Metastases||Drug: Carboplatin Drug: Etoposide Drug: Atezolizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Chemotherapy and Atezolizumab for Patients With Extensive Stage Small Cell Lung Cancer (SCLC) With Untreated, Asymptomatic Brain Metastases|
|Actual Study Start Date :||January 5, 2021|
|Estimated Primary Completion Date :||May 2023|
|Estimated Study Completion Date :||May 2024|
Experimental: Study Treatment Arm
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.
Carboplatin 5-6 mg/mL/min AUC will be delivered over 30 - 60 minutes intravenously on Day 1 of each 21 day Cycle after completion of atezolizumab. For 4 cycles.
Other Name: paraplatin
Etoposide 80-100 mg/m2 will be delivered over 60 minutes intravenously on Days 1-3 of each 21 day Cycle after completion of carboplatin (Day 1 only). For 4 cycles.
Other Name: VP-16
Atezolizumab 1200 mg will be delivered over 60 (± 15) minutes intravenously on Day 1 of each 21 day Cycle for 4 cycles then continue as monotherapy maintenance with the same schedule.
Other Name: Imfinzi
- Intracranial progression free survival (iPFS) [ Time Frame: 2 years ]iPFS is defined as the time from Day 1 of treatment until the criteria for intracranial disease progression is met as defined by RANO-BM or death as a result of any cause, whichever comes first.
- Overall Response Rate (ORR) [ Time Frame: 2 years ]ORR will include complete response (CR) + partial response (PR) as determined by RECIST 1.1.
- Overall Survival (OS) [ Time Frame: 2 years ]OS is defined as the time from Day 1 of treatment until death as a result of any cause.
- Frequency and severity of adverse events [ Time Frame: 2 years ]Toxicity will be graded by Common Toxicity Criteria for Adverse Events (CTCAE V5).
- Extracranial Progression Free Survival (PFS) [ Time Frame: 2 years ]Extracranial PFS is defined as the time from Day 1 of treatment until the criteria for extracranial disease progression is met as defined by RECIST 1.1 or death as a result of any cause, whichever comes first.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04610684
|Contact: Jeffrey Clarke, MDemail@example.com|
|Contact: Ahran Lee||317-634-5842 ext 14||Alee@hoosiercancer.org|
|United States, California|
|City of Hope||Recruiting|
|Duarte, California, United States, 91010|
|Contact: Alanna Muirhead 626-218-0961 firstname.lastname@example.org|
|Principal Investigator: Arya Amini, MD|
|United States, Illinois|
|University of Illinois Cancer Center||Recruiting|
|Chicago, Illinois, United States, 60612|
|Contact: Erin Keating 312-996-9913 email@example.com|
|Principal Investigator: Sushma Jonna, MD|
|United States, Indiana|
|St. Vincent Anderson Regional Hospital||Recruiting|
|Anderson, Indiana, United States, 46016|
|Contact: Dee Vester 765-648-4106 Dee.Vester@ascension.org|
|Principal Investigator: Praveen Ranaganath, MD|
|United States, Nebraska|
|Nebraska Methodist Hospital||Recruiting|
|Omaha, Nebraska, United States, 68114|
|Contact: Brianna Conyers 402-354-5162 Brianna.Conyers@nmhs.org|
|Principal Investigator: Timothy Dorius, MD|
|United States, New Jersey|
|Berkeley Heights, New Jersey, United States, 07922|
|Contact: Lorena Farrell 973-436-1752 firstname.lastname@example.org|
|Principal Investigator: Karleung Siu, MD|
|United States, North Carolina|
|Duke Cancer Institute||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Keiana Watkins 919-660-1278 email@example.com|
|Principal Investigator: Jeffrey Clarke, MD|
|Principal Investigator:||Jeffrey Clarke, MD||Duke University|