A Study of LY2875358 in Participants With Non-Small Cell Lung Cancer With Activating Epidermal Growth Factor Receptor Mutations
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Interventions
- Registration Number
- NCT01897480
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 150
- 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)
- 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- Have previously completed or withdrawn from this study or any other study investigating LY2875358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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LY2875358 plus Erlotinib LY2875358 Lead In: Approximately 8 weeks of erlotinib 150 milligram (mg) given orally per day. Randomization: Erlotinib 150 mg given orally per day plus 750 mg LY2875358 given as 1.5 hours intravenous (IV) infusions on Days 1 and 15 of 28-day cycles. Erlotinib Erlotinib Lead In: Approximately 8 weeks of erlotinib 150 mg given orally per day. Randomization: Continue Erlotinib 150 mg given orally per day, in 28-day cycles. LY2875358 plus Erlotinib Erlotinib Lead In: Approximately 8 weeks of erlotinib 150 milligram (mg) given orally per day. Randomization: Erlotinib 150 mg given orally per day plus 750 mg LY2875358 given as 1.5 hours intravenous (IV) infusions on Days 1 and 15 of 28-day cycles.
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) Randomization to Objective Disease Progression or Death Due to Any Cause (Estimated 3 Years)
- Secondary Outcome Measures
Name Time Method Change in Tumor Size (CTS) Baseline to Measurement with Smallest Tumor Size (Estimated 3 Years) Time to Progressive Disease (TTPD) Randomization to Objective Disease Progression (Estimated 3 Years) Proportion of Participants Exhibiting a Stable Disease (SD) or a confirmed CR or PR (Disease Control Rate [DCR]) Baseline to Objective Disease Progression or Participant Stops Study (Estimated 3 Years) Overall Survival (OS) Randomization to Death Due to Any Cause (Estimated 5 Years) Pharmacokinetics (PK): Area Under the Concentration Time Curve During a Dosing Interval (AUCtau) of LY2875358 and Erlotinib Baseline through Cycle 4 (28 Day Cycle) Proportion of Participants Exhibiting a Confirmed Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR]) Baseline to Objective Disease Progression or Start of New Anticancer Therapy (Estimated 3 Years) Duration of Response (DoR) Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Estimated 3 Years) 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) Baseline, Objective Disease Progression or Participants Stops Study (Estimated 3 Years) Proportion of Participants with Anti-LY2875358 Antibody Response Baseline through 30 Day Follow Up (Estimated 3 Years)
Trial Locations
- Locations (45)
Herlev and Gentofte Hospital
🇩🇰Herlev, Hovedstaden, Denmark
CHU de Caen Hopital Cote de Nacre
🇫🇷Caen, France
CHU De Grenoble Hopital Albert Michallon
🇫🇷Grenoble Cedex 09, France
HCL-Hôpital Louis Pradel
🇫🇷Lyon (Bron) Cedex, France
Chu Gabriel Montpied
🇫🇷Clermont-Ferrand, France
Hôpital Arnaud de Villeneuve - CHU Montpellier
🇫🇷Montpellier Cedex 5, France
CHU la Miletrie
🇫🇷Poitiers, France
Klinikum Köln-Merheim
🇩🇪Köln, Nordrhein-Westfalen, Germany
Azienda Ospedaliera Universitaria Careggi
🇮🇹Firenze, Florence, Italy
Helios Klinikum Emil von Behring Berlin-Zehlendorf
🇩🇪Berlin, Germany
Azienda Sanitaria Ospedaliera S Luigi Gonzaga
🇮🇹Orbassano, Torino, Italy
Istituto Tumori ""Giovanni Paolo II
🇮🇹Bari, Italy
Istituti Ospedalieri di Cremona
🇮🇹Cremona, Italy
Chungbuk National University Hospital
🇰🇷Cheongju-si, Chungcheongbuk-do [Chungbuk], Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Namdong-gu, Incheon-gwangyeoksi [Incheon], Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Korea, Republic of
Ulsan University Hospital
🇰🇷Ulsan, Ulsan-Kwangyǒkshi, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam, Kyǒnggi-do, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Corporacion Sanitaria Parc Tauli
🇪🇸Sabadell, Barcelona, Spain
Hospital Puerta De Hierro
🇪🇸Majadahonda, Madrid, Spain
Clinica Universitaria De Navarra
🇪🇸Pamplona, Navarra, Spain
Hospital Universitario Quironsalud Madrid
🇪🇸Pozuelo de Alarcon, Madrid, Spain
Gartnavel General Hospital
🇬🇧Glasgow, Glasgow City, United Kingdom
New Cross Hospital
🇬🇧Wolverhampton, West Midlands, United Kingdom
Churchill Hospital
🇬🇧Oxford, United Kingdom
Wythenshawe Hospital
🇬🇧Wythenshawe, Manchester, United Kingdom
Jeroen Bosch Hospital
🇳🇱Den Bosch, Noord-Brabant, Netherlands
Ziekenhuis Rijnstate
🇳🇱Arnhem, Netherlands
St. Antonius Ziekenhuis, locatie Nieuwegein
🇳🇱Nieuwegein, Netherlands
Universitätsklinikum Ulm
🇩🇪Ulm, Baden-Württemberg, Germany
Thoraxklinik-Heidelberg gGmbH
🇩🇪Heidelberg, Baden-Württemberg, Germany
Istituto Oncologico Veneto IRCCS
🇮🇹Padova, Veneto, Italy
Ziekenhuis St. Jansdal
🇳🇱Harderwijk, Netherlands
China Medical University Hospital
🇨🇳Taichung, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Klinik Schillerhöhe
🇩🇪Gerlingen, Baden-Württemberg, Germany
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
Universitätsklinikum Schleswig-Holstein
🇩🇪Lübeck, Schleswig-Holstein, Germany
Hospital del Mar
🇪🇸Barcelona, Spain
Rigshospitalet
🇩🇰Kobenhavn, Copenhagen, Denmark
Odense Universitetshospital
🇩🇰Odense C, Syd, Denmark
Charing Cross Hospital
🇬🇧Chelsea, London, United Kingdom