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Withdrawn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

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-

Find similar trials in Detroit, MI

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Henry Ford Health System· Detroit, MI

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