Phase III Study to Determine Efficacy of Durvalumab in Stage II-III Non-small Cell Lung Cancer (NSCLC) After Curative Intent Therapy.

Trial number:
Trial phase:
Study type:
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.


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,


Carcinoma, Non- Small Cell Lung

Other study ID numbers


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