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

NCT01897480 | Completed Phase 2

• 3 other identifiers: 14209I4C-MC-JTBB2024-514268-18-00
• Study Type: interventional
• Target: 168
• Locations: 9 countries
• Sites: 45

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  Randomization to Objective Disease Progression or Death Due to Any Cause (Estimated 3 Years)

Secondary Outcomes (9)

• 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)

• 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)

Study Arms (2)

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.

Biological: LY2875358; Drug: Erlotinib

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.

Drug: Erlotinib

Interventions

LY2875358 BIOLOGICAL

Administered IV

LY2875358 plus Erlotinib

Erlotinib DRUG

Administered Orally

Erlotinib; LY2875358 plus Erlotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (45)

Herlev and Gentofte Hospital

Herlev, Capital Region, 2730, Denmark

Location

Rigshospitalet

Copenhagen, Copenhagen, 2100, Denmark

Location

Odense Universitetshospital

Odense C, Syd, 5000, Denmark

Location

CHU de Caen Hopital Cote de Nacre

Caen, 14033, France

Location

Chu Gabriel Montpied

Clermont-Ferrand, 63000, France

Location

CHU De Grenoble Hopital Albert Michallon

Grenoble, 38043, France

Location

HCL-Hôpital Louis Pradel

Lyon (Bron) Cedex, 69677, France

Location

Hôpital Arnaud de Villeneuve - CHU Montpellier

Montpellier, 34295, France

Location

CHU la Miletrie

Poitiers, 86021, France

Location

Klinik Schillerhöhe

Gerlingen, Baden-Wurttemberg, 70839, Germany

Location

Thoraxklinik-Heidelberg gGmbH

Heidelberg, Baden-Wurttemberg, 69126, Germany

Location

Universitätsklinikum Ulm

Ulm, Baden-Wurttemberg, 89075, Germany

Location

Klinikum Köln-Merheim

Cologne, North Rhine-Westphalia, 51109, Germany

Location

Universitätsklinikum Schleswig-Holstein

Lübeck, Schleswig-Holstein, 23538, Germany

Location

Helios Klinikum Emil von Behring Berlin-Zehlendorf

Berlin, 14165, Germany

Location

Azienda Ospedaliera Universitaria Careggi

Florence, Florence, 50134, Italy

Location

Azienda Sanitaria Ospedaliera S Luigi Gonzaga

Orbassano, Torino, 10043, Italy

Location

Istituto Oncologico Veneto IRCCS

Padua, Veneto, 35128, Italy

Location

Istituto Tumori ""Giovanni Paolo II

Bari, 70124, Italy

Location

Istituti Ospedalieri di Cremona

Cremona, 26100, Italy

Location

Jeroen Bosch Hospital

's-Hertogenbosch, North Brabant, 5223 GZ, Netherlands

Location

Ziekenhuis Rijnstate

Arnhem, 6815 AD, Netherlands

Location

Ziekenhuis St. Jansdal

Harderwijk, 3844 DG, Netherlands

Location

St. Antonius Ziekenhuis, locatie Nieuwegein

Nieuwegein, 3435 CM, Netherlands

Location

Chungbuk National University Hospital

Cheongju-si, Chungcheongbuk-do [Chungbuk], 28644, South Korea

Location

Gachon University Gil Medical Center

Namdong-gu, Incheon-gwangyeoksi [Incheon], 21565, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, Korea, 03722, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, Kyǒnggi-do, 13620, South Korea

Location

Asan Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], 05505, South Korea

Location

Samsung Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], 06351, South Korea

Location

Ulsan University Hospital

Ulsan, Ulsan-Kwangyǒkshi, 44033, South Korea

Location

Corporacion Sanitaria Parc Tauli

Sabadell, Barcelona, 08208, Spain

Location

Hospital Puerta De Hierro

Majadahonda, Madrid, 28222, Spain

Location

Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

Clinica Universitaria De Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Gartnavel General Hospital

Glasgow, Glasgow City, G12OYN, United Kingdom

Location

Charing Cross Hospital

Chelsea, London, W6 8RF, United Kingdom

Location

Wythenshawe Hospital

Wythenshawe, Manchester, M23 9LT, United Kingdom

Location

New Cross Hospital

Wolverhampton, West Midlands, WV10 0QP, United Kingdom

Location

Churchill Hospital

Oxford, OX3 7LJ, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

emibetuzumab; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2013
• First Posted: July 12, 2013
• Study Start: August 28, 2013
• Primary Completion: March 14, 2016
• Study Completion: January 8, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 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.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

DK (3); IT (5); TW (4); GB (5); ES (5); DE (6); NL (4); FR (6); KR (7)