Study of durvalumab/placebo + chemoradiation Therapy in Patients with Locally Advanced Non-small Cell Lung Cancer

Phase 1

• Conditions: Patients with Locally Advanced, Unresectable Non-small Cell Lung Cancer (Stage III); MedDRA version: 21.1Level: PTClassification code 10029515Term: Non-small cell lung cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-004397-34-PL
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-15
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 390

Inclusion Criteria

- Subjects with histologically- or cytologically-documented NSCLC
- Locally advanced or metastatic, 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 234
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 156

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified