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Dacomitinib Plus PD-0325901 in Advanced KRAS Mutant NSCLC

NCT02039336 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2025-07-08

No results posted yet for this 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.

Conditions

Interventions

DRUG

Dacomitinib

DRUG

PD-0325901

DRUG

Docetaxel

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • The Netherlands Cancer Institute

    lead OTHER

Principal Investigators

  • f opdam, MD, PhD · The Netherlands Cancer Institute

  • FALM Eskens, PhD · Erasmus Medical Centre Cancer Institute

  • MPJK Lolkema, PhD · UMC Utrecht

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-02
Primary Completion
2018-08-07
Completion
2018-08-07

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02039336 on ClinicalTrials.gov