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NCT04470674

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

Withdrawn Phase 2 Last updated 3 March 2022
What this trial tests

Phase 2 trial testing Durvalumab in Lung Cancer. Withdrawn.

Timeline
6 April 2021
Primary endpoint
8 June 2021
8 June 2021

Quick facts

Lead sponsorShirish M Gadgeel
PhasePhase 2
StatusWithdrawn
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Start date6 April 2021
Primary completion8 June 2021
Estimated completion8 June 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Shirish M Gadgeel

Who can join

18 and older, any sex, with Lung Cancer or Non-small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Development of synthetic lethality in cancer: molecular and cellular classification.
    Li S, Topatana W, Juengpanich S, Cao J, et al · · 2020 · cited 82× · PMID 33077733 · DOI 10.1038/s41392-020-00358-6
  2. KRAS-Mutant Non-Small Cell Lung Cancer: An Emerging Promisingly Treatable Subgroup.
    Xie M, Xu X, Fan Y. · · 2021 · cited 46× · PMID 34012925 · DOI 10.3389/fonc.2021.672612
  3. Targeting KRAS in NSCLC: Old Failures and New Options for "Non-G12c" Patients.
    Jacobs F, Cani M, Malapelle U, Novello S, et al · · 2021 · cited 14× · PMID 34944952 · DOI 10.3390/cancers13246332
  4. [Application Progress of Immune Checkpoint Inhibitors 
in Oncogene-driven Advanced Non-small Cell Lung Cancer].
    Zhang T, Li B. · · 2021 · cited 1× · PMID 33819969 · DOI 10.3779/j.issn.1009-3419.2021.101.04

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Other trials of Durvalumab

Trials testing the same drug.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04470674.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing