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Carcinoma, Non-Small-Cell LungPhase 2BaliseNCT01897480

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

A Phase 2 study testing LY2875358 and Erlotinib in people with Carcinoma, Non-Small-Cell Lung, run by Eli Lilly and Company at 45 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
LY2875358 and Erlotinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
168 participants
Where
45 sitesin 9 countries
Study dates
28 Aug 2013to 8 Jan 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

45 sites in 9 countries.

45 sites in 9 countries

South Korea7 sites

  • Chungbuk National University Hospital

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

  • Gachon University Gil Medical Center

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

  • Seoul National University Bundang Hospital

    Seongnam, Kyǒnggi-do, 13620

  • Severance Hospital, Yonsei University Health System

    Seoul, Korea, 03722

  • Asan Medical Center

    Seoul, Seoul-teukbyeolsi [Seoul], 05505

  • Samsung Medical Center

    Seoul, Seoul-teukbyeolsi [Seoul], 06351

  • Ulsan University Hospital

    Ulsan, Ulsan-Kwangyǒkshi, 44033

Other trials in South Korea

France6 sites

  • CHU de Caen Hopital Cote de Nacre

    Caen, 14033

  • Chu Gabriel Montpied

    Clermont-Ferrand, 63000

  • CHU De Grenoble Hopital Albert Michallon

    Grenoble, 38043

  • HCL-Hôpital Louis Pradel

    Lyon (Bron) Cedex, 69677

  • Hôpital Arnaud de Villeneuve - CHU Montpellier

    Montpellier, 34295

  • CHU la Miletrie

    Poitiers, 86021

Other trials in France

Germany6 sites

  • Helios Klinikum Emil von Behring Berlin-Zehlendorf

    Berlin, 14165

  • Klinikum Köln-Merheim

    Cologne, North Rhine-Westphalia, 51109

  • Klinik Schillerhöhe

    Gerlingen, Baden-Wurttemberg, 70839

  • Thoraxklinik-Heidelberg gGmbH

    Heidelberg, Baden-Wurttemberg, 69126

  • Universitätsklinikum Schleswig-Holstein

    Lübeck, Schleswig-Holstein, 23538

  • Universitätsklinikum Ulm

    Ulm, Baden-Wurttemberg, 89075

Other trials in Germany

Italy5 sites

  • Istituto Tumori ""Giovanni Paolo II

    Bari, 70124

  • Istituti Ospedalieri di Cremona

    Cremona, 26100

  • Azienda Ospedaliera Universitaria Careggi

    Florence, Florence, 50134

  • Azienda Sanitaria Ospedaliera S Luigi Gonzaga

    Orbassano, Torino, 10043

  • Istituto Oncologico Veneto IRCCS

    Padova, Veneto, 35128

Other trials in Italy

Spain5 sites

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Puerta De Hierro

    Majadahonda, Madrid, 28222

  • Clinica Universitaria De Navarra

    Pamplona, Navarre, 31008

  • Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcón, Madrid, 28223

  • Corporacion Sanitaria Parc Tauli

    Sabadell, Barcelona, 08208

Other trials in Spain

United Kingdom5 sites

  • Charing Cross Hospital

    Chelsea, London, W6 8RF

  • Gartnavel General Hospital

    Glasgow, Glasgow City, G12OYN

  • Churchill Hospital

    Oxford, OX3 7LJ

  • New Cross Hospital

    Wolverhampton, West Midlands, WV10 0QP

  • Wythenshawe Hospital

    Wythenshawe, Manchester, M23 9LT

Other trials in United Kingdom

Netherlands4 sites

  • Jeroen Bosch Hospital

    's-Hertogenbosch, North Brabant, 5223 GZ

  • Ziekenhuis Rijnstate

    Arnhem, 6815 AD

  • Ziekenhuis St. Jansdal

    Harderwijk, 3844 DG

  • St. Antonius Ziekenhuis, locatie Nieuwegein

    Nieuwegein, 3435 CM

Other trials in Netherlands

Taiwan4 sites

  • China Medical University Hospital

    Taichung, 40447

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Taiwan University Hospital

    Taipei, 10002

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

Denmark3 sites

  • Rigshospitalet

    Copenhagen, Copenhagen, 2100

  • Herlev and Gentofte Hospital

    Herlev, Capital Region, 2730

  • Odense Universitetshospital

    Odense C, Syd, 5000

Other trials in Denmark

About this study

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

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.

Being tested
LY2875358, Erlotinib
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY2875358Biological

    Administered IV

  • ErlotinibDrug

    Administered Orally

Study groups in NCT01897480
Study groupRoleWhat they receive
LY2875358 plus ErlotinibExperimentalLead 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.
Receives: Biological: LY2875358; Drug: Erlotinib
ErlotinibActive comparatorLead 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.
Receives: Drug: Erlotinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS)

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

Secondary outcomes (9)

  1. Change in Tumor Size (CTS)

    Measured: Baseline to Measurement with Smallest Tumor Size (Estimated 3 Years)

  2. Proportion of Participants Exhibiting a Confirmed Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])

    Measured: Baseline to Objective Disease Progression or Start of New Anticancer Therapy (Estimated 3 Years)

  3. Duration of Response (DoR)

    Measured: Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Estimated 3 Years)

  4. Time to Progressive Disease (TTPD)

    Measured: Randomization to Objective Disease Progression (Estimated 3 Years)

  5. Proportion of Participants Exhibiting a Stable Disease (SD) or a confirmed CR or PR (Disease Control Rate [DCR])

    Measured: Baseline to Objective Disease Progression or Participant Stops Study (Estimated 3 Years)

  6. Overall Survival (OS)

    Measured: Randomization to Death Due to Any Cause (Estimated 5 Years)

  7. 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)

    Measured: Baseline, Objective Disease Progression or Participants Stops Study (Estimated 3 Years)

  8. Pharmacokinetics (PK): Area Under the Concentration Time Curve During a Dosing Interval (AUCtau) of LY2875358 and Erlotinib

    Measured: Baseline through Cycle 4 (28 Day Cycle)

  9. Proportion of Participants with Anti-LY2875358 Antibody Response

    Measured: Baseline through 30 Day Follow Up (Estimated 3 Years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2013 (estimated)
  2. Study start28 Aug 2013
  3. Primary completion14 Mar 2016
  4. Study completion8 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
168 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01897480
Sponsor's protocol ID
14209
Other IDs
I4C-MC-JTBB, 2024-514268-18-00
Acronym
Balise
Status last verified
Jan 2026
First submitted
9 Jul 2013
Last updated
26 Jan 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LY2875358 and Erlotinib in people with Carcinoma, Non-Small-Cell Lung, run by Eli Lilly and Company at 45 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in South Korea, France, Germany, Italy, Spain and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: Randomization to Objective Disease Progression or Death Due to Any Cause (Estimated 3 Years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01897480.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.

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