Combination of Durvalumab and Tremelimumab as Maintenance Treatment in Patients With Non Squamous and Squamous (NSCLC)

Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Study ID
NCT03319316
Phase
PHASE2
Status
Withdrawn

Conditions

  • Non-Squamous Non-small Cell Lung Cancer
  • Squamous Non-small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    Combination of durvalumab + tremelimumab treatment
  • Tremelimumab — DRUG
    Combination of durvalumab + tremelimumab treatment

Study Details

This is a multicenter, 2-arm open-label, randomized comparative phase II study in each of two separate cohorts (non-squamous NSCLC and squamous NSCLC) according to histology.

Key Dates

Start date
Nov 1, 2018
Status verified
Dec 2021
Primary completion
Nov 30, 2021
Completion
Nov 30, 2022

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1 - Non-squamous - Arm A
    Patients receive a maintenance treatment of durvalumab + tremelimumab
  • No Intervention: Cohort 1 - Non-squamous - Arm B
    Patients receive a maintenance treatment of pemetrexed
  • Experimental: Cohort 2 - Squamous - Arm A
    Patients receive a maintenance treatment of durvalumab + tremelimumab
  • No Intervention: Cohort 2 - Squamous - Arm B
    Patients will have observation

Primary Outcome Measure

Progression free survival (PFS) [ Time Frame: 4.3 years from FPI ]

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