Dacomitinib Plus PD-0325901 in Advanced KRAS Mutant NSCLC

Last updated: July 2, 2025
Sponsor: The Netherlands Cancer Institute
Overall Status: Completed

Phase

1/2

Condition

Colon Cancer

Colon Cancer; Rectal Cancer

Rectal Cancer

Treatment

Docetaxel

Dacomitinib

PD-0325901

Clinical Study ID

NCT02039336
NL45985.031.13
  • Ages > 18
  • All Genders

Study Summary

This is a phase I/II multi-center open-label proof of concept study, consisting of two parts. Part A of this study is designed to identify the recommended phase 2 dose (RP2D) of the combination regimen of dacomitinib plus PD-0325901 in patients with advanced KRAS mutant (KRASm) non-small cell lung cancer (NSCLC). Part B is designed to perform a randomized comparison of the combination of dacomitinib and PD-0325901 versus standard of care therapy in patients with advanced KRASm NSCLC. It is hypothesized that with this combination strategy the progression free survival of patients with KRASm NSCLC will be doubled.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histological or cytological proof of advanced non-small cell lung cancer

  • Written documentation of KRAS (exon 2, 3 or 4) mutation

  • At least 18 years of age or older

  • Able and willing to give written informed consent

  • WHO performance status of 0 or 1

Exclusion

Exclusion Criteria:

  • Symptomatic or untreated leptomeningeal disease

  • Symptomatic brain metastasis

  • Impairment of gastrointestinal function

  • Uncontrolled infectious disease

  • Left ventricular ejection fraction < 50%

  • Retinal degenerative disease or with history of uveitis, retinal vein occlusion orretinal detachment

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Total Participants: 35
Treatment Group(s): 3
Primary Treatment: Docetaxel
Phase: 1/2
Study Start date:
April 02, 2014
Estimated Completion Date:
August 07, 2018

Connect with a study center

  • The Netherlands Cancer Institute

    Amsterdam, 1066CX
    Netherlands

    Site Not Available

  • Erasmus Medical Center Cancer Institute

    Rotterdam, 3015CE
    Netherlands

    Site Not Available

  • University Medical Center Utrecht

    Utrecht, 3584CX
    Netherlands

    Site Not Available

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