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| ID | Type | Description | Link |
|---|---|---|---|
| I4C-MC-JTBB | Other Identifier | Eli Lilly and Company | |
| 2024-514268-18-00 | EU Trial (CTIS) Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY2875358 plus Erlotinib | Experimental | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2875358 | Biological | Administered IV |
| |
| Erlotinib |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | Randomization to Objective Disease Progression or Death Due to Any Cause (Estimated 3 Years) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Tumor Size (CTS) | Baseline to Measurement with Smallest Tumor Size (Estimated 3 Years) | |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herlev and Gentofte Hospital | Herlev | Capital Region | 2730 | Denmark | ||
| Rigshospitalet |
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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| Drug |
Administered Orally |
|
| Duration of Response (DoR) | Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (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) |
| 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) |
| 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 with Anti-LY2875358 Antibody Response | Baseline through 30 Day Follow Up (Estimated 3 Years) |
| Copenhagen |
| Copenhagen |
| 2100 |
| Denmark |
| Odense Universitetshospital | Odense C | Syd | 5000 | Denmark |
| CHU de Caen Hopital Cote de Nacre | Caen | 14033 | France |
| Chu Gabriel Montpied | Clermont-Ferrand | 63000 | France |
| CHU De Grenoble Hopital Albert Michallon | Grenoble | 38043 | France |
| HCL-Hôpital Louis Pradel | Lyon (Bron) Cedex | 69677 | France |
| Hôpital Arnaud de Villeneuve - CHU Montpellier | Montpellier | 34295 | France |
| CHU la Miletrie | Poitiers | 86021 | France |
| Klinik Schillerhöhe | Gerlingen | Baden-Wurttemberg | 70839 | Germany |
| Thoraxklinik-Heidelberg gGmbH | Heidelberg | Baden-Wurttemberg | 69126 | Germany |
| Universitätsklinikum Ulm | Ulm | Baden-Wurttemberg | 89075 | Germany |
| Klinikum Köln-Merheim | Cologne | North Rhine-Westphalia | 51109 | Germany |
| Universitätsklinikum Schleswig-Holstein | Lübeck | Schleswig-Holstein | 23538 | Germany |
| Helios Klinikum Emil von Behring Berlin-Zehlendorf | Berlin | 14165 | Germany |
| Azienda Ospedaliera Universitaria Careggi | Florence | Florence | 50134 | Italy |
| Azienda Sanitaria Ospedaliera S Luigi Gonzaga | Orbassano | Torino | 10043 | Italy |
| Istituto Oncologico Veneto IRCCS | Padova | Veneto | 35128 | Italy |
| Istituto Tumori ""Giovanni Paolo II | Bari | 70124 | Italy |
| Istituti Ospedalieri di Cremona | Cremona | 26100 | Italy |
| Jeroen Bosch Hospital | 's-Hertogenbosch | North Brabant | 5223 GZ | Netherlands |
| Ziekenhuis Rijnstate | Arnhem | 6815 AD | Netherlands |
| Ziekenhuis St. Jansdal | Harderwijk | 3844 DG | Netherlands |
| St. Antonius Ziekenhuis, locatie Nieuwegein | Nieuwegein | 3435 CM | Netherlands |
| Chungbuk National University Hospital | Cheongju-si | Chungcheongbuk-do [Chungbuk] | 28644 | South Korea |
| Gachon University Gil Medical Center | Namdong-gu | Incheon-gwangyeoksi [Incheon] | 21565 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | Korea | 03722 | South Korea |
| Seoul National University Bundang Hospital | Seongnam | Kyǒnggi-do | 13620 | South Korea |
| Asan Medical Center | Seoul | Seoul-teukbyeolsi [Seoul] | 05505 | South Korea |
| Samsung Medical Center | Seoul | Seoul-teukbyeolsi [Seoul] | 06351 | South Korea |
| Ulsan University Hospital | Ulsan | Ulsan-Kwangyǒkshi | 44033 | South Korea |
| Corporacion Sanitaria Parc Tauli | Sabadell | Barcelona | 08208 | Spain |
| Hospital Puerta De Hierro | Majadahonda | Madrid | 28222 | Spain |
| Hospital Universitario Quironsalud Madrid | Pozuelo de Alarcón | Madrid | 28223 | Spain |
| Clinica Universitaria De Navarra | Pamplona | Navarre | 31008 | Spain |
| Hospital del Mar | Barcelona | 08003 | Spain |
| China Medical University Hospital | Taichung | 40447 | Taiwan |
| Taichung Veterans General Hospital | Taichung | 40705 | Taiwan |
| National Taiwan University Hospital | Taipei | 10002 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| Gartnavel General Hospital | Glasgow | Glasgow City | G12OYN | United Kingdom |
| Charing Cross Hospital | Chelsea | London | W6 8RF | United Kingdom |
| Wythenshawe Hospital | Wythenshawe | Manchester | M23 9LT | United Kingdom |
| New Cross Hospital | Wolverhampton | West Midlands | WV10 0QP | United Kingdom |
| Churchill Hospital | Oxford | OX3 7LJ | United Kingdom |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000599789 | emibetuzumab |
| D000069347 | Erlotinib Hydrochloride |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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