LUX-Lung 8: A Phase III Trial of Afatinib (BIBW 2992) Versus Erlotinib for the Treatment of Squamous Cell Lung Cancer After at Least One Prior Platinum Based Chemotherapy

Part of paid clinical trials in Chandler, Arizona.

Sponsor
Boehringer Ingelheim
Study ID
NCT01523587
Phase
PHASE3
Status
Completed

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • afatinib — DRUG
    Afatinib taken once daily, continuously until disease progression or unacceptable toxicity.
  • erlotinib — DRUG
    erlotinib taken once daily

Study Details

This randomised, open-label phase III trial will be performed in patients with advanced squamous cell carcinoma of the lung requiring second-line treatment after receiving first-line platinum-based chemotherapy. The primary objective of this trial is to compare the efficacy of BIBW 2992 to erlotinib as second-line treatment in this group of patients.

Key Dates

Start date
Mar 5, 2012
Status verified
Feb 2019
Primary completion
Oct 21, 2013
Completion
Dec 27, 2017

Study Design

Enrollment
795 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Afatinib
    Patients receive afatinib tablets once daily
  • Active Comparator: Erlotinib
    Patients receive erlotinib tablets once daily

Primary Outcome Measure

Progression-free Survival, Based on Central Independent Review as Determined by Response Evaluation Criteria in Solid Tumours 1.1 [ Time Frame: First treatment administration up until cut off date of 02 March 2015 (up to 1058 days). ]

Locations (33)

FacilityCityStateZIPSite coordinators
Ironwood Cancer and Research CentersChandlerArizona85224-
University of CaliforniaLa JollaCalifornia92093-
Sutter Medical GroupSacramentoCalifornia95816-
Boca Raton Reginl Hospital-Lynn Cancer InstituteBoca RatonFlorida33486-
Memorial Healthcare SystemHollywoodFlorida22021-
Cancer Care of North Florida, PALake CityFlorida32024-
Illinois Cancer SpecialistsNilesIllinois60714-
Orchard Healthcare Research IncSkokieIllinois60076-
University of LouisvilleLouisvilleKentucky40202-
West Jefferson General Hospital and Cancer ClinicMarreroLouisiana70072-
Lahey ClinicBurlingtonMassachusetts01805-
Commonwealth Hematology-Oncology, PCLawrenceMassachusetts01841-
Karmanos Cancer InstituteDetroitMichigan48201-
Washington University School of MedicineSt LouisMissouri63110-
Billings Clinic Cancer CenterBillingsMontana59101-
Queens Medical AssociatesFresh MeadowsNew York11366-
SUNY Upstate Medical UniversitySyracuseNew York13210-
Montefiore Medical CenterThe BronxNew York10461-
Montefiore Medical CenterThe BronxNew York10467-
Cleveland ClinicClevelandOhio44195-
Mid Ohio Oncology/Hematology, IncColumbusOhio43219-
The Ohio State University Wexner Medical CenterColumbusOhio43201-
Kaiser Permanente NorthwestPortlandOregon97227-
Oncology Hematology Associates of Norhtern Pennsylvania, PCDuBoisPennsylvania15801-
Kimmel Cancer CenterPhiladelphiaPennsylvania19107-
Temple University Cancer CenterPhiladelphiaPennsylvania19140-
Spartanburg Regional Medical CenterSpartanburgSouth Carolina29303-
Cancer Center of Cookeville Regional Medical CenterCookevilleTennessee38501-
Paris Cancer Center (PCC), Texas OncologyParisTexas75460-
Cancer Therapy and Research at UTHSCSASan AntonioTexas78229-
Fletcher Allen Health CareBurlingtonVermont05401-
Blue Ridge Cancer CareChristiansburgVirginia24382-
Virginia Oncology AssociatesNorfolkVirginia23502-

Find similar trials in Chandler, AZ

By research site
Ironwood Cancer and Research Centers· Chandler, AZUniversity of California· La Jolla, CASutter Medical Group· Sacramento, CABoca Raton Reginl Hospital-Lynn Cancer Institute· Boca Raton, FLMemorial Healthcare System· Hollywood, FLCancer Care of North Florida, PA· Lake City, FL

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