Study of Durvalumab or Durvalumab Plus Chemotherapy in Kras Mutation Positive and PD-L1 High (≥ 50%) NSCLC Patients

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Shirish M Gadgeel
Study ID
NCT04470674
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

  • Durvalumab — DRUG
    Durvalumab 1500 mg
  • Carboplatin — DRUG
    carboplatin AUC 5
  • Pemetrexed — DRUG
    pemetrexed 500 mg/m2

Study Details

This is a two arm, randomized, phase II study of patients with advanced KRAS mutation positive and PD-L1 high NSCLC who have not received therapy for advanced stage disease. Patients will be randomized between Arm A and Arm B treatment. Arm A treatment will consist of durvalumab every 4 weeks for 13 cycles. Arm B treatment will consist of durvalumab with chemotherapy every 3 weeks for 4 cycles followed by durvalumab with pemetrexed every 3 weeks for 13 cycles.

Key Dates

First listed
Jul 14, 2020
Start date
Apr 6, 2021
Status verified
Feb 2022
Primary completion
Jun 8, 2021
Completion
Jun 8, 2021

Study Design

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

Arms

  • Active Comparator: Arm A (Durvalumab)
    Durvalumab 1500 mg IV every 4 weeks for 13 cycles.
  • Experimental: Arm B (Durvalumab plus chemotherapy)
    Durvalumab 1500 mg IV plus carboplatin AUC 5 IV and pemetrexed 500 mg/m2 IV every 3 weeks for 4 cycles followed by durvalumab and pemetrexed every 3 weeks for 13 more cycles.

Primary Outcome Measure

Response Rate [ Time Frame: 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Henry Ford Health SystemDetroitMichigan48202-

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By research site
Henry Ford Health System· Detroit, MI

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