NCT04982549

A Study to Evaluate the Safety of Concurrent Durvalumab With CRT Followed by Durvalumab for Chinese Unresectable Stage III NSCLC

A Prospective Study to Evaluate the Safety of Concurrent Durvalumab (MEDI4736) With Chemoradiation Therapy（CRT）Followed by Durvalumab for Chinese Unresectable Stage III Non Small Cell Lung Cancer（NSCLC）

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Shandong Cancer Hospital and Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multi-center, single arm study assessing the efficacy and safety of durvalumab given concurrently with platinum-based CRT (durvalumab + SoC CRT) in patients with locally advanced, unresectable NSCLC (Stage III).

Detailed description

Approximately 35 patients with locally advanced, unresectable NSCLC (Stage III) who are eligible to receive platinum-based CRT will be enrolled in and receive durvalumab + SoC CRT. Patients with CR, partial response (PR), or stable disease (SD）based on Investigator assessment at the 16-week tumor evaluation following completion of SoC CRT will continue to receive durvalumab as consolidation treatment. Patients with RECIST 1.1-defined radiological progressive disease (PD) will proceed to follow-up.

Conditions

• Unresectable Stage III NSCLC

Interventions

Type	Name	Description
DRUG	Durvalumab	Durvalumab (intravenous infusion)
DRUG	Carboplatin/ Paclitaxel	Carboplatin /Paclitaxel, as per standard of care
DRUG	Pemetrexed/ Cisplatin	Pemetrexed / Cisplatin, as per standard of care
DRUG	Pemetrexed/ Carboplatin	Pemetrexed / Carboplatin , as per standard of care
RADIATION	Radiation	5 fractions/ week for \~6 weeks (±3 days) (Total 60 Gy)

Timeline

• Start date: 2021-01-21
• Primary completion: 2022-12-01
• Completion: 2023-03-01
• First posted: 2021-07-29
• Last updated: 2021-08-06

Locations

2 sites across 1 country: China