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:
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.

1. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICFs and in the protocol. 2. Age ≥18 years at the time of screening (ICF1); 3. Histologically confirmed NSCLC with resectable stage II-III disease 4. Complete resection of the primary NSCLC

1. EGFR and/or ALK mutant 2. Mixed small cell and NSCLC histology 3. History of allogeneic organ or bone marrow transplantation 4. 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 (223)

National University Hospital 119228
National University Hospital 119228 Not yet recruiting
1E Kent Ridge Rd, Singapore 119228
National Cancer Centre Singapore
National Cancer Centre Singapore Recruiting
11 Hospital Crescent, Singapore 169610
Tan Tock Seng Hospital Singapore
Tan Tock Seng Hospital Singapore Not yet recruiting
11 Jln Tan Tock Seng, Level 1, Singapore 308433
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