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ALEctinib for the Treatment of Pretreated RET-rearranged Advanced Non-small Cell Lung Cancer

NCT03445000 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2025-04-08

Study results available
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Summary

A research study to evaluate the activity of alectinib for the Treatment of pretreated patients with advanced NSCLC that have confirmed RETrearrangement.

Conditions

Interventions

DRUG

Alectinib

Alectinib is administered orally 600mg (4x150mg capsules), twice per day (8 capsules, total 1200mg daily). The appropriate number of alectinib capsules will be provided to patients to be self-administered at home. Alectinib capsules must be taken at the same time each day with food. If a planned dose of alectinib is missed, patients can take the missed dose up until 6 hours before the next dose.

Sponsors & Collaborators

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • ETOP IBCSG Partners Foundation

    lead NETWORK

Principal Investigators

  • Enriqueta Felip, MD-PhD · Vall d'Hebron University Hospital

  • Jürgen Wolf, MD-PhD · University Hospital Cologne

  • Egbert F. Smith, MD-PhD · The Netherlands Cancer Institute Amsterdam

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-06
Primary Completion
2021-03-31
Completion
2021-03-31

Countries

  • Belgium
  • Ireland
  • Italy
  • Netherlands
  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

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 NCT03445000 on ClinicalTrials.gov