NCT04422210

A Study Evaluating The Safety, Tolerability, Pharmacokinetics, And Efficacy Of Venetoclax In Combination With Atezolizumab, Carboplatin, And Etoposide In Participants With Untreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC).

A Phase Ib Dose-Escalation and Dose-Expansion Study Evaluating The Safety, Tolerability, Pharmacokinetics, And Efficacy Of Venetoclax In Combination With Atezolizumab, Carboplatin, And Etoposide In Patients With Untreated Extensive-Stage Small Cell Lung Cancer.

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A study consisting of a dose-escalation phase and a dose-expansion phase to evaluate the safety, tolerability, pharmacokinetics, and efficacy of venetoclax in combination with atezolizumab, carboplatin, and etoposide.

Conditions

• Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Venetoclax	Venetoclax will be administered orally at escalating doses from 200mg to 800mg as 100mg tablets as per the dosing schedules described above.
DRUG	Atezolizumab	Atezolizumab will be administered via intravenous (IV) infusion at a fixed dose of 1200mg as per the dosing schedules described above.
DRUG	Carboplatin	Carboplatin will be administered via IV infusion at a dose of 5mg/mL/min as per the dosing schedules described above.
DRUG	Etoposide	Etoposide will be administered via IV infusion at a dose of 100mg/m\^2 as per the dosing schedules described above.

Timeline

• Start date: 2020-09-22
• Primary completion: 2020-11-06
• Completion: 2020-11-06
• First posted: 2020-06-09
• Last updated: 2021-11-08
• Results posted: 2021-11-08

Locations

5 sites across 4 countries: United States, Denmark, South Korea, Spain

Regulatory

• FDA-regulated drug study