Chemotherapy and Atezolizumab for Patients With Extensive Stage Small Cell Lung Cancer (SCLC) With Untreated, Asymptomatic Brain Metastases

Part of paid clinical trials in Duarte, California.

Sponsor
Jeffrey Clarke
Study ID
NCT04610684
Phase
PHASE2
Status
Terminated

Conditions

  • Brain Metastases
  • Small-cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Carboplatin — DRUG
    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.
  • Etoposide — DRUG
    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.
  • Atezolizumab — DRUG
    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.

Study Details

This is a single arm, multicenter phase II trial for 60 patients with untreated extensive stage (ES) small cell lung cancer (SCLC) with asymptomatic brain metastases. Subjects will receive 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). Each cycle equals 21 days. After 4 cycles of induction treatment, subjects will receive atezolizumab maintenance 1200 mg on Day 1 of each 3-week cycle. Subjects will receive treatment until disease progression, unacceptable drug-related toxicity, or withdrawal from study for any reason.

Key Dates

Start date
Jan 5, 2021
Status verified
Feb 2024
Primary completion
Jul 15, 2022
Completion
Sep 20, 2022

Study Design

Enrollment
3 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Intracranial Progression Free Survival (iPFS) [ Time Frame: From C1D1 until death or up to a maximum of 6 months ]

Locations (6)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
University of Illinois Cancer CenterChicagoIllinois60612-
St. Vincent Anderson Regional HospitalAndersonIndiana46016-
Nebraska Methodist HospitalOmahaNebraska68114-
Summit HealthBerkeley HeightsNew Jersey07922-
Duke Cancer InstituteDurhamNorth Carolina27710-

Find similar trials in Duarte, CA

By research site
City of Hope· Duarte, CAUniversity of Illinois Cancer Center· Chicago, ILSt. Vincent Anderson Regional Hospital· Anderson, INNebraska Methodist Hospital· Omaha, NESummit Health· Berkeley Heights, NJDuke Cancer Institute· Durham, NC

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