Stage III non-small cell lung cancer MedDRA version: 20.0 Level: PT Classification code 10029519 Term: Non-small cell lung cancer stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
MedImmune, LLC, a wholly owned subsidiary of AstraZeneca PLC
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Clinical activity - To compare the antitumor activity of durvalumab alone vs durvalumab in combination with novel agents.;Secondary Objective: Safety - To evaluate the safety and tolerability of durvalumab alone and durvalumab in combination with novel agents. Clinical activity - To further compare the efficacy of durvalumab alone vs durvalumab in combination with novel agents. Pharmacokinetics (a) To describe the pharmacokinetics (PK) of durvalumab alone and durvalumab in combination with novel agents. (b) To describe the PK of novel agents in combination with durvalumab. Immunogenicity (a) To assess the immunogenicity of durvalumab alone or in combination with novel agents (b) To assess the immunogenicity of novel biologic agents in combination with durvalumab;Primary end point(s): Clinical activity - Objective response (OR) per Response Evaluation Criteria for Solid Tumors version 1.1 (RECIST v1.1);Timepoint(s) of evaluation of this end point: From randomization until documention of disease progression, or the last evaluable disease assessment in the absence of PD prior to the initiation of subsequent anticancer therapy or discontinuation from the study, whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety - Presence of adverse events (AEs), serious adverse events (SAEs), and abnormal laboratory parameters and vital signs. Clinical activity - Duration of response (DoR), disease control (DC), progression-free survival (PFS) at 12 months, and PFS per RECIST v1.1 and overall survival (OS). Pharmacokinetics - Concentration of durvalumab or novel agents in serum. Immunogenicity - Antidrug antibody (ADA) incidence of durvalumab or novel biologic agents;Timepoint(s) of evaluation of this end point: Safety - From time of informed consent through treatment period (12 months) or up to 3 months post last dose of study treatment. DoR - From randomization until documention of disease progression. DC - From randomization until progression, or the last evaluable disease assessment in the absence of PD prior to the initiation of subsequent anticancer therapy or discontinuation from the study, whichever occurs first. PFS and OS - From start of treatment until study completion or death, whichever comes first. Pharmacokinetics and immunogenicity - During the treatment period and follow-up. | — |
Countries
Canada, France, Germany, Hong Kong, Italy, Poland, Portugal, Spain, Taiwan, United States
Contacts
Public ContactClinical Trial Enquiries
MedImmune, LLC, a wholly owned subsidiary of AstraZeneca PLC
Outcome results
None listed