NCT03872661

Neoadjuvant IBI308, Bevacizumab, Plus Pemetrexed and Carboplatin Followed by Surgery in Unresectable Stage III NSCLC

A Multicenter Phase II Trial of Neoadjuvant IBI308, Bevacizumab, Plus Pemetrexed and Carboplatin Followed by Surgery in Patients With Unresectable Stage III Non-Small Cell Lung Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to studying neoadjuvant IBI308, bevacizumab, plus pemetrexed and carboplatin followed by surgery to see how well it works in treating patients with unresectable stage III non-small cell lung cancer.

Detailed description

Concurrent chemoradiotherapy is the recommended therapeutic approach for patients with unresectable stage III non-small cell lung cancer (NSCLC), although surgery offers the chance of cure. With combined-modality therapy with radiation therapy and chemotherapy, the prognosis of stage III NSCLC remains poor. IBI308 (sintilimab) is a recombinant humanized anti-PD-1 monoclonal antibody. This study is to studying neoadjuvant IBI308, bevacizumab, plus pemetrexed and carboplatin followed by surgery to see how well it works in treating patients with unresectable stage III non-small cell lung cancer.

Conditions

• Lung Cancer Stage III

Interventions

Type	Name	Description
DRUG	IBI308	IBI308 was given 200 mg iv infusion on day 1 of each 21-day cycle for 4 cycles.
DRUG	Bevacizumab	Bevacizumab was administered at a dose of 15 mg/kg on day 1 of each 21-day cycle for 4 cycles.
DRUG	Pemetrexed	Pemetrexed was given 500 mg/m\^2 i.v. injection on day 1 of each 21-day cycle for 4 cycles.
DRUG	Carboplatin	Carboplatin was given dosed to an area under the serum concentration-time curve (AUC) of 5 i.v. on day 1 of each 21-day cycle for 4 cycles.
PROCEDURE	Thoracic surgery	Surgery will be performed at least 21 days after the last dose of neoadjuvant therapy.

Timeline

• Start date: 2019-03-01
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2019-03-13
• Last updated: 2024-12-06

Locations

1 site across 1 country: China