NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
Sponsor: AstraZeneca
Conditions: Non-Small Cell Lung Cancer, Small Cell Lung Cancer
Interventions: Durvalumab, Cisplatin, Carboplatin, Etoposide
Countries: United States, New Zealand, Spain, Taiwan
This study has 2 parts: dose finding and dose confirmatory. In Part 1, the dose finding phase of the study, there will be 3 or more dosing levels to find out what dose of durvalumab administered as an infusion under the skin acts similarly to durvalumab administered into a vein. 24 participants with Non-Small Cell Lung Cancer will be enrolled for a 12 month treatment period and 3 months follow up In Part 2, the dose confirmation phase of the study, participants will receive the dose of durvalumab identified in Part 1 of the study. The goal of Part 2 will be to learn more about the way that the body processes durvalumab when administered as an infusion under the skin. Approximately 90 participants with Non-Small Cell Lung Cancer will be enrolled; additionally, up to 10 participants with Small Cell Lung Cancer (who will receive concurrent chemotherapy) will be enrolled for a 12 treatment period and a 3 month follow-up period. AstraZeneca has decided to stop further enrollment and the study was terminated when all patients in Part 1 (Phase I) completed their last study visit. No safety issues or clinical concerns however, have been identified for this study. Part 2 (Phase II) was not initiated.
Sex: ALL
Age: 18 Years to 130 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * Histologically or cytologically documented unresectable Stage III NSCLC that has not progressed following definitive platinum based CRT or extensive disease (Stage IV) SCLC * ECOG performance status of 0 or 1 * For participants with SCLC: At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 TL at baseline * Absence of EGFR mutation or ALK rearrangement prior to screening Exclusion Criteria: * History of allogeneic organ transplantation * Autoimmune or inflammatory disorders, diverticulitis, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome * Uncontrolled intercurrent illness * History of another primary malignancy * History of active primary immunodeficiency * Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) * Brain metastases or spinal cord compression * Persistent toxicities (CTCAE Grade \>2) caused by previous anticancer therapy, excluding alopecia * Receipt of live attenuated vaccine within 30 days prior to the first dose of IP
- Houston, Texas, United States
- Fairfax, Virginia, United States
- Christchurch, New Zealand
- Badalona, Spain
- Majadahonda, Spain
- Taichung, Taiwan
- Taipei, Taiwan
- Taipei, Taiwan