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

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