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- Have previously completed or withdrawn from this study or any other study investigating LY2875358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
Sites (36)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Helios Klinikum Emil von Behring Berlin-Zehlendorf Coordinator of this site? Confirm its status | Berlin | Germany | Completed |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
| Herlev and Gentofte Hospital Coordinator of this site? Confirm its status | Herlev | Denmark | Unknown status |
| Odense Universitetshospital Coordinator of this site? Confirm its status | Odense C | Denmark | Unknown status |
| Hospital Universitario Quironsalud Madrid Coordinator of this site? Confirm its status | Pozuelo de Alarcón | Spain | Completed |
| CHU de Caen Hopital Cote de Nacre Coordinator of this site? Confirm its status | Caen | France | Unknown status |
| Chu Gabriel Montpied Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Unknown status |
| CHU De Grenoble Hopital Albert Michallon Coordinator of this site? Confirm its status | Grenoble | France | Unknown status |
| HCL-Hôpital Louis Pradel Coordinator of this site? Confirm its status | Lyon (Bron) Cedex | France | Unknown status |
| Hôpital Arnaud de Villeneuve - CHU Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| CHU la Miletrie Coordinator of this site? Confirm its status | Poitiers | France | Unknown status |
| Charing Cross Hospital Coordinator of this site? Confirm its status | Chelsea | United Kingdom | Unknown status |
| Gartnavel General Hospital Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| Churchill Hospital Coordinator of this site? Confirm its status | Oxford | United Kingdom | Unknown status |
| New Cross Hospital Coordinator of this site? Confirm its status | Wolverhampton | United Kingdom | Unknown status |
| Wythenshawe Hospital Coordinator of this site? Confirm its status | Wythenshawe | United Kingdom | Unknown status |
| Istituto Tumori Giovanni Paolo II Coordinator of this site? Confirm its status | Bari | Italy | Unknown status |
| Istituti Ospedalieri di Cremona Coordinator of this site? Confirm its status | Cremona | Italy | Unknown status |
| Azienda Ospedaliera Universitaria Careggi Coordinator of this site? Confirm its status | Florence | Italy | Unknown status |
| Azienda Sanitaria Ospedaliera S Luigi Gonzaga Coordinator of this site? Confirm its status | Orbassano | Italy | Unknown status |
| Istituto Oncologico Veneto - IRCCS Coordinator of this site? Confirm its status | Padova | Italy | Unknown status |
| Chungbuk National University Hospital Coordinator of this site? Confirm its status | Cheongju-si | South Korea | Unknown status |
| Gachon University Gil Medical Center Coordinator of this site? Confirm its status | Namdong-gu | South Korea | Unknown status |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Ulsan University Hospital Coordinator of this site? Confirm its status | Ulsan | South Korea | Unknown status |
| Ziekenhuis Rijnstate Coordinator of this site? Confirm its status | Arnhem | Netherlands | Unknown status |
| Ziekenhuis St Jansdal Coordinator of this site? Confirm its status | Harderwijk | Netherlands | Unknown status |
| St. Antonius Ziekenhuis, locatie Nieuwegein Coordinator of this site? Confirm its status | Nieuwegein | Netherlands | Unknown status |
| Jeroen Bosch Hospital Coordinator of this site? Confirm its status | 's-Hertogenbosch | Netherlands | Unknown status |
| China Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| Taichung Veterans General Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Taipei Veterans General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.