Neoadjuvant Durvalumab Alone or in Combination With Novel Agents in Resectable Non-Small Cell Lung Cancer

Completed · Phase 2

Conditions studied: Resectable, Early-stage, NSCLC

In brief

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).

Key facts

Study ID

NCT03794544

Run by

MedImmune LLC

People needed

84

Starts

2019-03-08

Expected to finish

2021-01-13

Last updated by the study team

2022-02-24

Who can join

Age: 18 and older, up to 102. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — La Jolla, California, United States
• Research Site — Fort Myers, Florida, United States
• Research Site — Leesburg, Florida, United States
• Research Site — Baltimore, Maryland, United States
• Research Site — Buffalo, New York, United States
• Research Site — New York, New York, United States
• Research Site — Chattanooga, Tennessee, United States
• Research Site — Nashville, Tennessee, United States
• Research Site — Houston, Texas, United States
• Research Site — Fairfax, Virginia, United States
• Research Site — Montreal, Quebec, Canada
• Research Site — Marseille, France
• Research Site — Toulouse, France
• Research Site — Orbassano, Italy
• Research Site — Porto, Portugal
• Research Site — A Coruña, Spain
• Research Site — Barcelona, Spain
• Research Site — Zurich, Switzerland

Full record on ClinicalTrials.gov

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