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

Status: Active

Description

Study D9108C00002 (NeoCOAST) is a platform study assessing the effectiveness and safety of neoadjuvant durvalumab alone or in combination with novel agents in subjects 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 subjects 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
  • Age ≥18 years old
  • Predicted FEV1 ≥ 50%
  • Predicted DLCO ≥ 50%
  • ECOG 0 or 1
  • Adequate organ function

Exclusion Criteria

  • Subjects with small-cell lung cancer or mixed small-cell lung cancer
  • Subjects who require or may require pneumonectomy
  • Prior treatment with PD-L1, PD-L1, or 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:
  • Subjects with vitiligo or alopecia
  • Subjects with hypothyroidism on hormone replacement
  • Any chronic skin condition that does not require systemic therapy
  • Subjects without active disease in the last 5 years may be included but only after consultation with the study physician
  • Subjects 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 subject 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

Locations & Contacts

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: Active
Name Not Available

Minnesota

Minneapolis
University of Minnesota / Masonic Cancer Center
Status: Active
Name Not Available

New York

New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: Active
Name Not Available

Texas

Houston
M D Anderson Cancer Center
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
MedImmune Inc

Trial IDs

Primary ID D9108C00002
Secondary IDs NCI-2019-03500
Clinicaltrials.gov ID NCT03794544