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NCT01897480CompletedPhase 2

A Study of LY2875358 in Participants With Non-Small Cell Lung Cancer With Activating Epidermal Growth Factor Receptor Mutations

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

Source: ClinicalTrials.gov · Last updated 26 Jan 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
168 (actual)
First submitted
9 Jul 2013
Start date
28 Aug 2013
Primary completion date
14 Mar 2016
Lead sponsor
Eli Lilly and Company
Diseases
Lung cancer
NCT number
NCT01897480
EU CT number
2024-514268-18-00
EudraCT number
2012-005476-33

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 168
  • From 28 Aug 2013 to the primary completion date, 14 Mar 2016
  • 36 sites in 9 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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  • Have previously completed or withdrawn from this study or any other study investigating LY2875358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 major surgery less than 2 weeks prior to the initiation of study treatment therapy

Other illness

  • 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

Other

  • 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
  • Pregnant or lactating women

Who the study is looking for

  • 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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (36)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Helios Klinikum Emil von Behring Berlin-Zehlendorf
Coordinator of this site? Confirm its status
BerlinGermanyCompleted
Rigshospitalet
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CopenhagenDenmarkUnknown status
Herlev and Gentofte Hospital
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HerlevDenmarkUnknown status
Odense Universitetshospital
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Odense CDenmarkUnknown status
Hospital Universitario Quironsalud Madrid
Coordinator of this site? Confirm its status
Pozuelo de AlarcónSpainCompleted
CHU de Caen Hopital Cote de Nacre
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CaenFranceUnknown status
Chu Gabriel Montpied
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Clermont-FerrandFranceUnknown status
CHU De Grenoble Hopital Albert Michallon
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GrenobleFranceUnknown status
HCL-Hôpital Louis Pradel
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Lyon (Bron) CedexFranceUnknown status
Hôpital Arnaud de Villeneuve - CHU Montpellier
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MontpellierFranceUnknown status
CHU la Miletrie
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PoitiersFranceUnknown status
Charing Cross Hospital
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ChelseaUnited KingdomUnknown status
Gartnavel General Hospital
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GlasgowUnited KingdomUnknown status
Churchill Hospital
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OxfordUnited KingdomUnknown status
New Cross Hospital
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WolverhamptonUnited KingdomUnknown status
Wythenshawe Hospital
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WythenshaweUnited KingdomUnknown status
Istituto Tumori Giovanni Paolo II
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BariItalyUnknown status
Istituti Ospedalieri di Cremona
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CremonaItalyUnknown status
Azienda Ospedaliera Universitaria Careggi
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FlorenceItalyUnknown status
Azienda Sanitaria Ospedaliera S Luigi Gonzaga
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OrbassanoItalyUnknown status
Istituto Oncologico Veneto - IRCCS
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PadovaItalyUnknown status
Chungbuk National University Hospital
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Cheongju-siSouth KoreaUnknown status
Gachon University Gil Medical Center
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Namdong-guSouth KoreaUnknown status
Seoul National University Bundang Hospital
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SeongnamSouth KoreaUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
Asan Medical Center
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SeoulSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaUnknown status
Ulsan University Hospital
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UlsanSouth KoreaUnknown status
Ziekenhuis Rijnstate
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ArnhemNetherlandsUnknown status
Ziekenhuis St Jansdal
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HarderwijkNetherlandsUnknown status
St. Antonius Ziekenhuis, locatie Nieuwegein
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NieuwegeinNetherlandsUnknown status
Jeroen Bosch Hospital
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's-HertogenboschNetherlandsUnknown status
China Medical University Hospital
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TaichungTaiwanUnknown status
Taichung Veterans General Hospital
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TaichungTaiwanUnknown status
National Taiwan University Hospital
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TaipeiTaiwanUnknown status
Taipei Veterans General Hospital
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TaipeiTaiwanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.