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OpenTrials
Completed

NCT Number: NCT02039336

Dacomitinib Plus PD-0325901 in Advanced KRAS Mutant NSCLC

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The Netherlands Cancer Institute, Amsterdam, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dacomitinib

Drug

PD-0325901

Drug

docetaxel

Drug

Primary outcomes

  1. Incidence rate of dose-limiting toxicities

    Time frame: 1.5 years

  2. Progression free survival

    Time frame: 2.5 years

Secondary outcomes

  1. Incidence and severity of adverse events

    Time frame: 2.5 years

  2. Plasma concentration

    Time frame: 2.5 years

  3. Overall response rate

    Time frame: 2.5 years

  4. Duration of response

    Time frame: 1.5 years

  5. Time to response

    Time frame: 2.5 years

  6. Overall survival

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

The Netherlands Cancer Institute

Other

Collaborators

  • Pfizer

Registry information

Official study title

Phase I/II Study With the Combination of Dacomitinib and PD-0325901 in Metastatic KRAS Mutation Positive Non-small Cell Lung Cancer

Acronym: M13DAP

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jan 17, 2014
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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