Phase III Study to Determine Efficacy of Durvalumab in Stage II-III Non-small Cell Lung Cancer (NSCLC) After Curative Intent Therapy.
- Trial number:
-
NCT04642469
- Trial phase:
- 3
- Study type:
- Immunotherapy
- Overall status:
- Active, not recruiting
Study start date
November, 2020
Scientific title
A Phase III, Randomized, Multicenter, Double-blind, Placebo-controlled Study of Durvalumab for the Treatment of Stage II-III NSCLC Patients With Minimal Residual Disease Following Surgery and Curative Intent Therapy.
Summary
This is a Phase III double-blind, placebo-controlled study of Durvalumab versus Placebo in patients with stage II-III NSCLC who are MRD-positive following curative intent therapy.
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICFs and in the protocol.Age ≥18 years at the time of screening (ICF1); Histologically confirmed NSCLC with resectable stage II-III disease Complete resection of the primary NSCLC
EGFR and/or ALK mutantMixed small cell and NSCLC histology History of allogeneic organ or bone marrow transplantation History of active primary immunodeficiency
Study design
Primary purpose:
Treatment,
Allocation:
Randomized,
Intervention model:
Parallel Assignment,
Masking:
Quadruple,
Masking description:
Double Blind,
Subject masked:
Yes,
Caregiver masked:
Yes,
Investigator masked:
Yes,
Outcomes assessor masked:
Yes,
Conditions
Carcinoma, Non- Small Cell Lung
Other study ID numbers
D910MC00001
Choose trial site (251)
National University Hospital 119228
1E Kent Ridge Rd, Singapore 119228
National Cancer Centre Singapore
General Hospital, Block 6 Level 1, 169608, Outram Rd, Singapore 169074
Tan Tock Seng Hospital Singapore
11 Jln Tan Tock Seng, Level 1, Singapore 308433