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Dacomitinib Plus PD-0325901 in Advanced KRAS Mutant NSCLC (M13DAP)

Netherlands Cancer Institute (NKI) logo

Netherlands Cancer Institute (NKI)

Status and phase

Unknown
Phase 2
Phase 1

Conditions

Colorectal Cancer

Treatments

Drug: Docetaxel
Drug: PD-0325901
Drug: Dacomitinib

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02039336
NL45985.031.13

Details and patient eligibility

About

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.

Enrollment

35 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 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 or retinal detachment

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

35 participants in 1 patient group

Dacomitinib + PD-0325901
Experimental group
Description:
Dacomitinib: oral tablets PD-0325901: oral capsules
Treatment:
Drug: Dacomitinib
Drug: Docetaxel
Drug: PD-0325901

Trial contacts and locations

3

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Central trial contact

F Opdam, MD, PhD

Data sourced from clinicaltrials.gov

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