A study of durvalumab alone or in combination with other agents in subjects with non-small cell lung cancer that is not removable by surgery

Phase 1

• Conditions: Stage III non-small cell lung cancer; MedDRA version: 20.0Level: PTClassification code 10029519Term: Non-small cell lung cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-002931-35-FR
• Lead Sponsor: MedImmune, LLC, a wholly owned subsidiary of AstraZeneca PLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-23
• Last Update Posted: 23 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Written informed consent and any locally required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluation
2. Age 18 years or older
3. Body weight = 35 kg
4. Subjects must have histologically or cytologically documented NSCLC who present with locally advanced, unresectable, Stage III disease
5. Subjects must have completed, without progressing, definitive cCRT within 28 days prior to being randomized into the study.
6. Subjects must have at least one previously irradiated tumor lesion that can be measured by RECIST v1.1
7. Provision of tumor tissue sample, when available, from original diagnosis obtained before initiation of chemoradiotherapy
8. Life expectancy = 12 weeks
9. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
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 225
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75

Exclusion Criteria

1. Mixed small cell and non-small cell lung cancer histology
2. Current or prior use of immunosuppressive medication within 14 days before the first dose of study drug.
3. Subjects with history of = Grade 2 pneumonitis from prior chemoradiation therapy
4. Subjects with a history of venous thrombosis within the past 3 months
5. Subjects with history of myocardial infarction, transient ischemic attack, or stroke in the past 6 months
6. Congestive heart failure
7. Active or prior documented autoimmune or inflammatory disorders
8. History of active primary immunodeficiency
9. Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
10. History of allogenic organ transplantation
11. QTcF interval = 470 ms
12. History of another primary malignancy
13. Concurrent enrollment in another therapeutic clinical study or during the follow-up period of an interventional study. Enrollment in observational studies will be allowed
14. Females who are pregnant, lactating, or intend to become pregnant during their participation in the study

Study & Design

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