A PHASE III, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, MULTI-CENTER, INTERNATIONAL STUDY OF DURVALUMAB GIVEN CONCURRENTLY WITH PLATINUM-BASED CHEMORADIATION THERAPY IN PATIENTS WITH LOCALLY ADVANCED, UNRESECTABLE NON-SMALL CELL LUNG CANCER (STAGE III) (PACIFIC 2)

Not Applicable

Recruiting

• Conditions: -C34 Malignant neoplasm of bronchus and lung; Malignant neoplasm of bronchus and lung; C34

• Registration Number: PER-009-18
• Lead Sponsor: AstraZeneca AB,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-20
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

1.Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
2.Provision of signed and dated, written ICF prior to any mandatory study-specific procedures, sampling, and analyses.
3.18 years or older at the time of signing the ICF. In Japan, patients must be 20 years or older at the time of signing the ICF.
4.Histologically or cytologically documented NSCLC who present with locally advanced, unresectable (Stage III) disease (according to Version 8 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology [IASLC Staging Manual in Thoracic Oncology 2016]).
Except for overt cT4 disease, nodal status N2 or N3 should be proven by biopsy, via endobronchial ultrasound, mediastinoscopy, or thoracoscopy. Absent biopsy, nodal status should be confirmed with whole body 18F-fluoro-deoxyglucose positron emission tomography, plus contrast-enhanced computed tomography (CT) in addition to or in combination with PET.
Mandatory brain magnetic resonance imaging (MRI; preferred) or high-quality brain CT with IV contrast at the time of staging.

Please for complete information refer to page 39-41

Exclusion Criteria

1.History of allogeneic organ transplantation.
2.Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn´s disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves´ disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). The following are exceptions to this criterion:
Patients with vitiligo or alopecia
Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement
Any chronic skin condition that does not require systemic therapy
Patients without active disease in the last 5 years at randomization may be included but only after consultation with the study physician
Patients with celiac disease controlled by diet alone

Please for complete information refer to page 41-44

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Study & Design

• Study Type: Interventional
• Study Design: Not specified