CompletedPhase 2NCT03822351

Durvalumab Alone or in Combination With Novel Agents in Subjects With NSCLC

The purpose of this study is to compare the clinical activity of durvalumab alone vs durvalumab in combination with novel agents. The overall study goal is early identification of novel durvalumab combinations that are more active than durvalumab alone in the treatment of patients with unresectable, Stage III NSCLC who have not progressed after cCRT.

Checked against the public recordLast updated Oct 8, 2024 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 2
U.S. locations73
SponsorMedImmune LLC
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
MedImmune LLC
Interventions being studied
Drug: Durvalumab + Oleclumab; Drug: Durvalumab; Drug: Durvalumab + Monalizumab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Main Inclusion Criteria: 1. Written informed consent and any locally required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluation 2. Age 18 years or older 3. Body weight ≥ 35 kg 4. Subjects must have histologically or cytologically documented NSCLC who present with locally advanced, unresectable, Stage III disease 5. Subjects must have completed, without progressing, definitive cCRT within 42 days prior to being randomized into the study 6. Provision of tumor tissue sample, when available, from original diagnosis obtained before initiation of chemoradiotherapy 7. Life expectancy ≥ 12 weeks 8. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 9. Subjects must have at least one previously irradiated tumor lesion that can be measured by RECIST v1.1 Main Exclusion Criteria: 1. Mixed small cell and non-small cell lung cancer histology 2. Current or prior use of immunosuppressive medication within 14 days before the first dose of study drug 3. Prior exposure to any anti-PD1, anti-PD-L1, or anti-CTLA4 antibody for treatment of NSCLC 4. Subjects with history of ≥ Grade 2 pneumonitis from prior chemoradiation therapy 5. Subjects with a history of venous thrombosis within the past 3 months 6. Subjects with history of myocardial infarction, transient ischemic attack, or stroke in the past 6 months 7. Congestive heart failure 8. Active or prior documented autoimmune or inflammatory disorders 9. History of active primary immunodeficiency 10. Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) 11. History of allogenic organ transplantation 12. QTcF interval ≥ 470 ms 13. History of another primary malignancy 14. Concurrent enrollment in another clinical study \[concurrent enrollment in an observational (non-interventional) clinical study or during the follow-up period of an interventional study is permitted\] 15. Females who are pregnant, lactating, or intend to become pregnant during their participation in the study

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Research SiteAnaheim, California
  • Research SiteDuarte, California
  • Research SiteSacramento, California
  • Research SiteNew Haven, Connecticut
  • Research SiteWest Haven, Connecticut
  • Research SiteWashington D.C., District of Columbia
  • Research SiteOrlando, Florida
  • Research SiteWinter Haven, Florida
  • Research SiteWichita, Kansas
  • Research SiteLexington, Kentucky
  • Research SiteLouisville, Kentucky
  • Research SiteBaton Rouge, Louisiana

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 8, 2024. Always confirm current availability with the study team.

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