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

Carcinoma, Non-Small-Cell Lung Clinical Trial

— Balise  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01897480
• Other study ID #: 14209
• Secondary ID: I4C-MC-JTBB2012-
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: August 28, 2013
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: December 31, 2024
• Est. primary completion date: March 14, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Biological:
• LY2875358
Administered IV

Drug:
• Erlotinib
Administered Orally

Locations

Country	Name	City	State
Denmark	Herlev and Gentofte Hospital	Herlev	Hovedstaden
Denmark	Rigshospitalet	Kobenhavn	Copenhagen
Denmark	Odense Universitetshospital	Odense C	Syd
France	CHU de Caen Hopital Cote de Nacre	Caen
France	Chu Gabriel Montpied	Clermont-Ferrand
France	CHU De Grenoble Hopital Albert Michallon	Grenoble Cedex 09
France	HCL-Hôpital Louis Pradel	Lyon (Bron) Cedex
France	Hôpital Arnaud de Villeneuve - CHU Montpellier	Montpellier Cedex 5
France	CHU la Miletrie	Poitiers
Germany	Helios Klinikum Emil von Behring Berlin-Zehlendorf	Berlin
Germany	Klinik Schillerhöhe	Gerlingen	Baden-Württemberg
Germany	Thoraxklinik-Heidelberg gGmbH	Heidelberg	Baden-Württemberg
Germany	Klinikum Köln-Merheim	Köln	Nordrhein-Westfalen
Germany	Universitätsklinikum Schleswig-Holstein	Lübeck	Schleswig-Holstein
Germany	Universitätsklinikum Ulm	Ulm	Baden-Württemberg
Italy	Istituto Tumori ""Giovanni Paolo II	Bari
Italy	Istituti Ospedalieri di Cremona	Cremona
Italy	Azienda Ospedaliera Universitaria Careggi	Firenze	Florence
Italy	Azienda Sanitaria Ospedaliera S Luigi Gonzaga	Orbassano	Torino
Italy	Istituto Oncologico Veneto IRCCS	Padova	Veneto
Korea, Republic of	Chungbuk National University Hospital	Cheongju-si	Chungcheongbuk-do [Chungbuk]
Korea, Republic of	Gachon University Gil Medical Center	Namdong-gu	Incheon-gwangyeoksi [Incheon]
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Kyonggi-do
Korea, Republic of	Asan Medical Center	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Samsung Medical Center	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul	Korea
Korea, Republic of	Ulsan University Hospital	Ulsan	Ulsan-Kwangyokshi
Netherlands	Ziekenhuis Rijnstate	Arnhem
Netherlands	Jeroen Bosch Hospital	Den Bosch	Noord-Brabant
Netherlands	Ziekenhuis St. Jansdal	Harderwijk
Netherlands	St. Antonius Ziekenhuis, locatie Nieuwegein	Nieuwegein
Spain	Hospital del Mar	Barcelona
Spain	Hospital Puerta De Hierro	Majadahonda	Madrid
Spain	Clinica Universitaria De Navarra	Pamplona	Navarra
Spain	Hospital Universitario Quironsalud Madrid	Pozuelo de Alarcon	Madrid
Spain	Corporacion Sanitaria Parc Tauli	Sabadell	Barcelona
Taiwan	China Medical University Hospital	Taichung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
United Kingdom	Charing Cross Hospital	Chelsea	London
United Kingdom	Gartnavel General Hospital	Glasgow	Glasgow City
United Kingdom	Churchill Hospital	Oxford
United Kingdom	New Cross Hospital	Wolverhampton	West Midlands
United Kingdom	Wythenshawe Hospital	Wythenshawe	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

Denmark,  France,  Germany,  Italy,  Korea, Republic of,  Netherlands,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS)		Randomization to Objective Disease Progression or Death Due to Any Cause (Estimated 3 Years)
Secondary	Change in Tumor Size (CTS)		Baseline to Measurement with Smallest Tumor Size (Estimated 3 Years)
Secondary	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)
Secondary	Duration of Response (DoR)		Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Estimated 3 Years)
Secondary	Time to Progressive Disease (TTPD)		Randomization to Objective Disease Progression (Estimated 3 Years)
Secondary	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)
Secondary	Overall Survival (OS)		Randomization to Death Due to Any Cause (Estimated 5 Years)
Secondary	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)
Secondary	Pharmacokinetics (PK): Area Under the Concentration Time Curve During a Dosing Interval (AUCtau) of LY2875358 and Erlotinib		Baseline through Cycle 4 (28 Day Cycle)
Secondary	Proportion of Participants with Anti-LY2875358 Antibody Response		Baseline through 30 Day Follow Up (Estimated 3 Years)