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

Locations

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