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Afatinib and Selumetinib in Advanced KRAS Mutant and PIK3CA Wildtype Non-small Cell Lung Cancer

NCT02450656 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2018-08-27

No results posted yet for this study

Summary

This is a multi-center open-label proof-of-concept study consisting of two parts: PART A - a phase I dose-finding study (3 + 3 classical design) evaluating the RP2D of afatinib in combination with selumetinib in KRASm NSCLC; and PART B - a randomized phase II study investigating the progression free survival and safety of selumetinib/afatinib combination therapy compared to standard of care chemotherapy in KRASm NSCLC.

Conditions

  • Colorectal Neoplasms
  • Gastrointestinal Neoplasms
  • Pancreatic Neoplasms
  • Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

Afatinib

Tablet

DRUG

Selumetinib

Capsule

DRUG

Docetaxel

Sponsors & Collaborators

Principal Investigators

  • F Opdam, MD, PhD · NKI-AvL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2019-05-31
Completion
2019-12-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs
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 NCT02450656 on ClinicalTrials.gov