NCT05026593

A Study of IBI110 in Combination With Sintilimab and Chemotherapy in Patients With Untreated Extensive-Stage Small Cell Lung Cancer

A Randomized, Multicenter, Open-Label, Phase Ib Study to Evaluate Efficacy, Safety and Tolerability of IBI110 in Combination With Sintilimab Plus Etoposide and Platinum or Carboplatin in Patients With Untreated Extensive-Stage Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

IBI110 is an investigational drug under evaluation for treatment of small cell lung cancer. The purpose of the study was to assess the Efficacy and Safety of IBI110 in combination with Sintilimab and chemotherapy with untreated ES-SCLC.

Detailed description

This Phase II, multicenter, open-lable study is designed to evaluate the safety and efficacy of IBI110 (anti-lymphocyte activation gene 3 \[LAG-3\] monoclonal antibody) and sintilimab (anti-programmed death 1 \[PD-1\] antibody) in combination with intravenous (IV) cisplatin/carboplatin plus (+) etoposide (EP) in treatment naïve patients with extensive-stage small cell lung cancer (ES-SCLC) . Sixty eligible subjects will be enrolled and randomized in a 1:1 ratio to the experimental arm or the control arm. The experimental arm will be IBI110+ sintilimab + EP Q3W for 4 cycles, followed by IBI110+ sintilimab Q3W until disease progression. The control arm will be sintilimab + EP Q3W for 4 cycles, followed by sintilimab Q3W until disease progression.

Conditions

• SCLC

Interventions

Type	Name	Description
DRUG	Carboplatin	Carboplatin will be administered after completion of Sintilimab by IV infusion to achieve an initial target AUC of 5 mg/mL/min on Day 1.
DRUG	Cisplatin	Cisplatin 75 mg/m\^2 will be administered after completion of Sintilimab by IV infusion on Day 1.
DRUG	Etoposide	Etoposide 100 mg/m\^2 will be administered by IV infusion following carboplatin or cisplatin administration, during the induction phase on Day 1 through 3 of each cycle. On Days 2 and 3, patients will receive etoposide alone.
DRUG	Sintilimab	Sintilimab 200 mg will be administered by IV infusion following IBI110 on Day 1 of each 21-day .
DRUG	IBI110	IBI110 RP2D will be administered by IV infusion on Day 1 of each 21-day .

Timeline

• Start date: 2021-09-07
• Primary completion: 2023-02-16
• Completion: 2023-06-26
• First posted: 2021-08-30
• Last updated: 2023-07-19

Locations

1 site across 1 country: China