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

NCT04470674 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2022-03-03

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Durvalumab

Durvalumab 1500 mg

DRUG

Carboplatin

carboplatin AUC 5

DRUG

Pemetrexed

pemetrexed 500 mg/m2

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Henry Ford Health System

    collaborator OTHER

  • Shirish M Gadgeel

    lead OTHER

Principal Investigators

  • Shirish M Gadgeel, MBBS · Henry Ford Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-06
Primary Completion
2021-06-08
Completion
2021-06-08
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04470674 on ClinicalTrials.gov