Clinical trial NCT01897480: A Study of LY2875358 in Participants With Non-Small Cell Lung Cancer With Activating Epidermal Growth Factor Receptor Mutations
Official title: A Randomized, Controlled Phase 2 Study Evaluating LY2875358 Plus Erlotinib Versus Erlotinib as First-Line Treatment in Metastatic Non-Small Cell Lung Cancer Patients With Activating EGFR Mutations Who Have Disease Control After an 8-Week Lead-In Treatment With Erlotinib
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2013-07-12
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to compare the efficacy of the study drug LY2875358, given together with erlotinib, against erlotinib, alone. Participants will have Non-Small Cell Lung Cancer (NSCLC) that has advanced to Stage IV. Participants should not have been treated with drugs for Stage IV NSCLC, previously. All participants will get erlotinib alone, for approximately 8 weeks. Participants with radiographic disease control at the end of the erlotinib lead-in study period will be randomly assigned to receive LY2875358 plus erlotinib or erlotinib alone. Participants, who were chosen to receive erlotinib, alone, may cross over to the combination treatment at the time of progression.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of metastatic Stage IV NSCLC
* Have at least 1 measurable lesion whose presence is assessable using standard techniques by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1)
* Have molecular evidence of an epidermal growth factor receptor mutation (EGFRmt) known to be associated with EGFR tyrosine kinase inhibitor (TKI) drug sensitivity (G719X, exon 19 deletion, L858R, L861Q)
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
* Haven't received any prior systemic chemotherapy for Stage IV NSCLC (unless received as neoadjuvant or adjuvant therapy for early-stage NSCLC disease and completed therapy at least 6 months prior to enrollment)
* Availability of adequate tumor material (block or slides)

Exclusion Criteria:

* Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device
* Have previously completed or withdrawn from this study or any other study investigating LY2875358
* Have a serious concomitant systemic disorder or significant cardiac disease
* Have interstitial pneumonia or interstitial fibrosis of the lung or have pleural effusion, pericardial fluids or ascites, requiring drainage every other week or more frequently
* Have a history of another malignancy except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, or other solid tumors treated curatively and without evidence of recurrence for at least 3 years prior to the study
* Have major surgery less than 2 weeks prior to the initiation of study treatment therapy
* Pregnant or lactating women

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Randomization to Objective Disease Progression or Death Due to Any Cause (Estimated 3 Years)
Secondary outcomes:
measure: Change in Tumor Size (CTS)
timeFrame: Baseline to Measurement with Smallest Tumor Size (Estimated 3 Years)
measure: Proportion of Participants Exhibiting a Confirmed Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])
timeFrame: Baseline to Objective Disease Progression or Start of New Anticancer Therapy (Estimated 3 Years)
measure: Duration of Response (DoR)
timeFrame: Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Estimated 3 Years)
measure: Time to Progressive Disease (TTPD)
timeFrame: Randomization to Objective Disease Progression (Estimated 3 Years)
measure: Proportion of Participants Exhibiting a Stable Disease (SD) or a confirmed CR or PR (Disease Control Rate [DCR])
timeFrame: Baseline to Objective Disease Progression or Participant Stops Study (Estimated 3 Years)
measure: Overall Survival (OS)
timeFrame: Randomization to Death Due to Any Cause (Estimated 5 Years)
measure: Change from Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQ) C30 (QLQ-C30) and Lung Cancer 13 (QLQ-LC13)
timeFrame: Baseline, Objective Disease Progression or Participants Stops Study (Estimated 3 Years)
measure: Pharmacokinetics (PK): Area Under the Concentration Time Curve During a Dosing Interval (AUCtau) of LY2875358 and Erlotinib
timeFrame: Baseline through Cycle 4 (28 Day Cycle)
measure: Proportion of Participants with Anti-LY2875358 Antibody Response
timeFrame: Baseline through 30 Day Follow Up (Estimated 3 Years)
Other outcomes:
Locations:
city: Kobenhavn
country: Denmark
facility: Rigshospitalet
state: Copenhagen
city: Herlev
country: Denmark
facility: Herlev and Gentofte Hospital
state: Hovedstaden
city: Odense C
country: Denmark
facility: Odense Universitetshospital
state: Syd
city: Caen
country: France
facility: CHU de Caen Hopital Cote de Nacre
city: Clermont-Ferrand
country: France
facility: Chu Gabriel Montpied
city: Grenoble Cedex 09
country: France
facility: CHU De Grenoble Hopital Albert Michallon
city: Lyon (Bron) Cedex
country: France
facility: HCL-Hôpital Louis Pradel
city: Montpellier Cedex 5
country: France
facility: Hôpital Arnaud de Villeneuve - CHU Montpellier
city: Poitiers
country: France
facility: CHU la Miletrie
city: Gerlingen
country: Germany
facility: Klinik Schillerhöhe
state: Baden-Württemberg
city: Heidelberg
country: Germany
facility: Thoraxklinik-Heidelberg gGmbH
state: Baden-Württemberg
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
state: Baden-Württemberg
city: Köln
country: Germany
facility: Klinikum Köln-Merheim
state: Nordrhein-Westfalen
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Helios Klinikum Emil von Behring Berlin-Zehlendorf
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
state: Florence
city: Orbassano
country: Italy
facility: Azienda Sanitaria Ospedaliera S Luigi Gonzaga
state: Torino
city: Padova
country: Italy
facility: Istituto Oncologico Veneto IRCCS
state: Veneto
city: Bari
country: Italy
facility: Istituto Tumori ""Giovanni Paolo II
city: Cremona
country: Italy
facility: Istituti Ospedalieri di Cremona
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
state: Chungcheongbuk-do [Chungbuk]
city: Namdong-gu
country: Korea, Republic of
facility: Gachon University Gil Medical Center
state: Incheon-gwangyeoksi [Incheon]
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
state: Korea
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Kyǒnggi-do
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul-teukbyeolsi [Seoul]
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
state: Ulsan-Kwangyǒkshi
city: Den Bosch
country: Netherlands
facility: Jeroen Bosch Hospital
state: Noord-Brabant
city: Arnhem
country: Netherlands
facility: Ziekenhuis Rijnstate
city: Harderwijk
country: Netherlands
facility: Ziekenhuis St. Jansdal
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis, locatie Nieuwegein
city: Sabadell
country: Spain
facility: Corporacion Sanitaria Parc Tauli
state: Barcelona
city: Majadahonda
country: Spain
facility: Hospital Puerta De Hierro
state: Madrid
city: Pozuelo de Alarcon
country: Spain
facility: Hospital Universitario Quironsalud Madrid
state: Madrid
city: Pamplona
country: Spain
facility: Clinica Universitaria De Navarra
state: Navarra
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Glasgow
country: United Kingdom
facility: Gartnavel General Hospital
state: Glasgow City
city: Chelsea
country: United Kingdom
facility: Charing Cross Hospital
state: London
city: Wythenshawe
country: United Kingdom
facility: Wythenshawe Hospital
state: Manchester
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
state: West Midlands
city: Oxford
country: United Kingdom
facility: Churchill Hospital
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: