drugset / Trial / NCT04470674

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

NCT04470674 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2021-04-06
Primary completion
2021-06-08
Completion
2021-06-08

Outcome

Outcome not reported

Stopped (Enrollment): “Lack of Accrual”

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule 5 unknown Intravenous
Subject Durvalumab Monoclonal antibody 1500 mg Intravenous
Subject Pemetrexed Small molecule 500 mg/m2 Intravenous