Lung Cancer Clinical Trial
Neoadjuvant Durvalumab Alone or in Combination With Novel Agents in Resectable Non-Small Cell Lung Cancer
Summary
Study D9108C00002 (NeoCOAST) is a platform study assessing the effectiveness and safety of neoadjuvant durvalumab alone or in combination with novel agents in participants with resectable, early-stage (Stage I [>2cm] to IIIA) non-small cell lung cancer (NSCLC).
Eligibility Criteria
Inclusion Criteria:
Cytologically and/or histologically-documented NSCLC
Stage I (> 2 cm) to IIIA (for participants with N2 disease, only those with 1 single nodal station ≤ 3 cm are eligible) NSCLC according to the 8th edition of American Joint Committee on Cancer staging classification
Amenable to complete surgical resection
Have not received any other therapy for this condition
Predicted forced expiratory volume in one second (FEV1) ≥ 50%
Predicted diffusing capacity of the lungs for carbon monoxide (DLCO) ≥ 50%
ECOG 0 or 1
Adequate organ function
Exclusion Criteria:
Participants with small-cell lung cancer or mixed small-cell lung cancer
Participants who require or may require pneumonectomy
Prior treatment with programmed cell death ligand-1 (PD-L1), PD-L1, or cytotoxic T-lymphocyte antigen 4 (CTLA-4) inhibitors
Current or prior use of immunosuppressive medication within 14 days before the first dose of study drug.
Active or prior documented autoimmune or inflammatory disorders. The following are exceptions to this criterion:
Participants with vitiligo or alopecia
Participants with hypothyroidism on hormone replacement
Any chronic skin condition that does not require systemic therapy
Participants without active disease in the last 5 years may be included but only after consultation with the study physician
Participants with celiac disease controlled by diet alone
Pregnant or breast-feeding female
Major surgical procedure within prior 30 days
History of active primary immunodeficiency
Active infection including tuberculosis, hepatitis B, hepatitis C, or HIV
QTc interval (QTc) ≥ 470 ms
Uncontrolled intercurrent illness that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the participant to give written informed consent
Receipt of live attenuated vaccination within 30 days prior to study entry
History of another primary malignancy except for:
Curative-treated malignancy with no known active disease > 2 years before enrollment on the study
Curative-treated non-melanoma skin cancer and/or carcinoma in-situ
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There are 18 Locations for this study
La Jolla California, 92093, United States
Fort Myers Florida, 33901, United States
Leesburg Florida, 34748, United States
Baltimore Maryland, 21231, United States
Buffalo New York, 14263, United States
New York New York, 10016, United States
Chattanooga Tennessee, 37404, United States
Nashville Tennessee, 37203, United States
Houston Texas, 77030, United States
Fairfax Virginia, 22031, United States
Montreal Quebec, H4A 3, Canada
Marseille Cedex 9 , 13009, France
Toulouse CEDEX 09 , 31059, France
Orbassano , 10043, Italy
Porto , 4200-, Portugal
A Coruña , 15001, Spain
Barcelona , 08916, Spain
Zurich , 8091, Switzerland
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