Study of Durvalumab Given With Chemoradiation Therapy in Patients With Unresectable Non-small Cell Lung Cancer

• Status: Active, not recruiting
• Trial end date: 2023-11-13
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase III, randomized, double-blind, placebo-controlled, multi-center, international study assessing the efficacy and safety of durvalumab given concurrently with platinum-based CRT (durvalumab + standard of care [SoC] CRT) in patients with locally advanced, unresectable NSCLC (Stage III).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Albumin-Bound Paclitaxel; Antibodies, Monoclonal; Carboplatin; Cisplatin; Durvalumab; Etoposide; Etoposide phosphate; Paclitaxel; Pemetrexed

Criteria

Principal inclusion criteria :

• Subjects with histologically- or cytologically-documented NSCLC

• Locally advanced, unresectable (Stage III) NSCLC

• World Health Organisation (WHO) performance status 0-1

• At least one measurable lesion, not previously irradiated

• Must have a life expectancy of at least 12 weeks at randomization

Principal exclusion criteria :

• Receipt of prior or current cancer treatment, including but not limited to, radiation therapy, investigational agents, chemotherapy, Durvalumab and mAbs.

• Prior exposure to immune-mediated therapy, including but not limited to, other anti CTLA-4, anti-PD-1, anti-PD-L1, and anti PD L2 antibodies, excluding therapeutic anticancer vaccines.

• History of allogeneic organ transplantation

• Active or prior documented autoimmune or inflammatory disorders

• Uncontrolled intercurrent illness

• History of another primary malignancy / leptomeningeal carcinomatosis / active primary immunodeficiency

• Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus

• Mixed small cell and NSCLC histology

• Any medical contraindication to treatment with platinum-based doublet chemotherapy as listed in the local labelling

• Known allergy or hypersensitivity to any of the IPs or any of the IP excipients.

• Patients whose radiation treatment plans are likely to encompass a volume of whole lung receiving ≥20 Gy in total (V20) of more than 35% of lung volume.