Status:
COMPLETED
Neoadjuvant Durvalumab Alone or in Combination With Novel Agents in Resectable Non-Small Cell Lung Cancer
Lead Sponsor:
MedImmune LLC
Conditions:
Resectable
Early-stage
Eligibility:
All Genders
18-102 years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 13 2021
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT03794544
Start Date
March 8 2019
End Date
January 13 2021
Last Update
February 24 2022
Active Locations (18)
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1
Research Site
La Jolla, California, United States, 92093
2
Research Site
Fort Myers, Florida, United States, 33901
3
Research Site
Leesburg, Florida, United States, 34748
4
Research Site
Baltimore, Maryland, United States, 21231