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

February 29, 2024 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Copenhagen
      • Kobenhavn, Copenhagen, Denmark, 2100
        • Rigshospitalet
    • Hovedstaden
      • Herlev, Hovedstaden, Denmark, 2730
        • Herlev and Gentofte Hospital
    • Syd
      • Odense C, Syd, Denmark, 5000
        • Odense Universitetshospital
  • France
      • Caen, France, 14033
        • CHU de Caen Hôpital Cote de Nacre
      • Clermont-Ferrand, France, 63000
        • Chu Gabriel Montpied
      • Grenoble Cedex 09, France, 38043
        • CHU De Grenoble Hopital Albert Michallon
      • Lyon (Bron) Cedex, France, 69677
        • HCL-Hôpital Louis Pradel
      • Montpellier Cedex 5, France, 34295
        • Hôpital Arnaud de Villeneuve - CHU Montpellier
      • Poitiers, France, 86021
        • CHU La Milétrie
  • Germany
      • Berlin, Germany, 14165
        • Helios Klinikum Emil von Behring Berlin-Zehlendorf
    • Baden-Württemberg
      • Gerlingen, Baden-Württemberg, Germany, 70839
        • Klinik Schillerhohe
      • Heidelberg, Baden-Württemberg, Germany, 69126
        • Thoraxklinik-Heidelberg gGmbH
      • Ulm, Baden-Württemberg, Germany, 89075
        • Universitatsklinikum Ulm
    • Nordrhein-Westfalen
      • Köln, Nordrhein-Westfalen, Germany, 51109
        • Klinikum Köln-Merheim
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23538
        • Universitatsklinikum Schleswig-Holstein
  • Italy
      • Bari, Italy, 70124
        • Istituto Tumori ""Giovanni Paolo II
      • Cremona, Italy, 26100
        • Istituti Ospedalieri di Cremona
    • Florence
      • Firenze, Florence, Italy, 50134
        • Azienda Ospedaliera Universitaria Careggi
    • Torino
      • Orbassano, Torino, Italy, 10043
        • Azienda Sanitaria Ospedaliera S Luigi Gonzaga
    • Veneto
      • Padova, Veneto, Italy, 35128
        • Istituto Oncologico Veneto IRCCS
  • Korea, Republic of
    • Chungcheongbuk-do [Chungbuk]
      • Cheongju-si, Chungcheongbuk-do [Chungbuk], Korea, Republic of, 28644
        • Chungbuk National University Hospital
    • Incheon-gwangyeoksi [Incheon]
      • Namdong-gu, Incheon-gwangyeoksi [Incheon], Korea, Republic of, 21565
        • Gachon University Gil Medical Center
    • Korea
      • Seoul, Korea, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University Health System
    • Kyǒnggi-do
      • Seongnam, Kyǒnggi-do, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 06351
        • Samsung Medical Center
    • Ulsan-Kwangyǒkshi
      • Ulsan, Ulsan-Kwangyǒkshi, Korea, Republic of, 44033
        • Ulsan University Hospital
  • Netherlands
      • Arnhem, Netherlands, 6815 AD
        • Ziekenhuis Rijnstate
      • Harderwijk, Netherlands, 3844 DG
        • Ziekenhuis St. Jansdal
      • Nieuwegein, Netherlands, 3435 CM
        • St. Antonius ziekenhuis, locatie Nieuwegein
    • Noord-Brabant
      • Den Bosch, Noord-Brabant, Netherlands, 5223 GZ
        • Jeroen Bosch Hospital
  • Spain
      • Barcelona, Spain, 08003
        • Hospital del Mar
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Corporacion Sanitaria Parc Tauli
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Puerta de Hierro
      • Pozuelo de Alarcon, Madrid, Spain, 28223
        • Hospital Universitario Quironsalud Madrid
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Clinica Universitaria de Navarra
  • Taiwan
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
  • United Kingdom
      • Oxford, United Kingdom, OX3 7LJ
        • Churchill Hospital
    • Glasgow City
      • Glasgow, Glasgow City, United Kingdom, G12OYN
        • Gartnavel General Hospital
    • London
      • Chelsea, London, United Kingdom, W6 8RF
        • Charing Cross Hospital
    • Manchester
      • Wythenshawe, Manchester, United Kingdom, M23 9LT
        • Wythenshawe Hospital
    • West Midlands
      • Wolverhampton, West Midlands, United Kingdom, WV10 0QP
        • New Cross Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LY2875358 plus 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.
Drug: Erlotinib
Administered Orally
Biological: LY2875358
Administered IV
Active Comparator: 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.
Drug: Erlotinib
Administered Orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival (PFS)
Time Frame: Randomization to Objective Disease Progression or Death Due to Any Cause (Estimated 3 Years)
Randomization to Objective Disease Progression or Death Due to Any Cause (Estimated 3 Years)

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Tumor Size (CTS)
Time Frame: Baseline to Measurement with Smallest Tumor Size (Estimated 3 Years)
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])
Time Frame: Baseline to Objective Disease Progression or Start of New Anticancer Therapy (Estimated 3 Years)
Baseline to Objective Disease Progression or Start of New Anticancer Therapy (Estimated 3 Years)
Duration of Response (DoR)
Time Frame: Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Estimated 3 Years)
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)
Time Frame: Randomization to Objective Disease Progression (Estimated 3 Years)
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])
Time Frame: Baseline to Objective Disease Progression or Participant Stops Study (Estimated 3 Years)
Baseline to Objective Disease Progression or Participant Stops Study (Estimated 3 Years)
Overall Survival (OS)
Time Frame: Randomization to Death Due to Any Cause (Estimated 5 Years)
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)
Time Frame: Baseline, Objective Disease Progression or Participants Stops Study (Estimated 3 Years)
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
Time Frame: Baseline through Cycle 4 (28 Day Cycle)
Baseline through Cycle 4 (28 Day Cycle)
Proportion of Participants with Anti-LY2875358 Antibody Response
Time Frame: Baseline through 30 Day Follow Up (Estimated 3 Years)
Baseline through 30 Day Follow Up (Estimated 3 Years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 28, 2013

Primary Completion (Actual)

March 14, 2016

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

July 9, 2013

First Submitted That Met QC Criteria

July 11, 2013

First Posted (Estimated)

July 12, 2013

Study Record Updates

Last Update Posted (Estimated)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14209
  • I4C-MC-JTBB (Other Identifier: Eli Lilly and Company)
  • 2012-005476-33 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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