Durvalumab and Tremelimumab for Adjuvant Therapy of Resected NSCLC

Sponsor
Columbia University
Study ID
NCT03130764
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    1500 mg, IV over 1 hour Every 4 weeks for 1 year
  • Tremelimumab — DRUG
    75 mg, IV over 1 hour Every 4 weeks for 4 doses

Study Details

Despite aggressive surgery and chemotherapy, the risk of lung cancer recurrence remains high in most patients. This study aims to determine if a novel immune therapy consisting of two drugs is feasible and potentially increases the chance of cure in lung cancer patients after surgery and standard chemotherapy. The immune-based therapy being given in this study consists of two medications named durvalumab and tremelimumab.

Key Dates

Start date
Mar 31, 2017
Status verified
Dec 2017
Primary completion
Nov 30, 2017
Completion
Nov 30, 2017

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Durvalumab/Tremelimumab
    Patients with resected stage IB-IIIA NSCLC who have completed standard adjuvant therapy (as recommended by the treating physician) to receive durvalumab-tremelimumab will be enrolled. Patients will receive durvalumab (20 mg/kg) intravenously every 4 weeks for 1 year and tremelimumab (1 mg/kg) intravenously every 4 weeks for 4 doses.

Primary Outcome Measure

The percentage rate of induced T-cell response in resected NSCLC patients [ Time Frame: Upto 1 year ]

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