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New combo shows promise for lung cancer patients

NCT ID NCT01897480

Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether adding a new drug (LY2875358) to the standard treatment erlotinib helps people with advanced non-small cell lung cancer that has a specific gene mutation. All 168 participants first took erlotinib alone for 8 weeks. Those whose cancer did not worsen were then randomly assigned to continue erlotinib alone or add the new drug. The goal was to see if the combination delayed cancer growth longer than erlotinib alone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

168 people

The number who actually took part.

Started

Aug 2013

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Carcinoma, non-small-cell lung

Contacts and locations

Locations

  • Asan Medical Center

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

  • Azienda Ospedaliera Universitaria Careggi

    Florence, Florence, 50134, Italy

  • Azienda Sanitaria Ospedaliera S Luigi Gonzaga

    Orbassano, Torino, 10043, Italy

  • CHU De Grenoble Hopital Albert Michallon

    Grenoble, 38043, France

  • CHU de Caen Hopital Cote de Nacre

    Caen, 14033, France

  • CHU la Miletrie

    Poitiers, 86021, France

  • Charing Cross Hospital

    Chelsea, London, W6 8RF, United Kingdom

  • China Medical University Hospital

    Taichung, 40447, Taiwan

  • Chu Gabriel Montpied

    Clermont-Ferrand, 63000, France

  • Chungbuk National University Hospital

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

  • Churchill Hospital

    Oxford, OX3 7LJ, United Kingdom

  • Clinica Universitaria De Navarra

    Pamplona, Navarre, 31008, Spain

  • Corporacion Sanitaria Parc Tauli

    Sabadell, Barcelona, 08208, Spain

  • Gachon University Gil Medical Center

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

  • Gartnavel General Hospital

    Glasgow, Glasgow City, G12OYN, United Kingdom

  • HCL-Hôpital Louis Pradel

    Lyon (Bron) Cedex, 69677, France

  • Helios Klinikum Emil von Behring Berlin-Zehlendorf

    Berlin, 14165, Germany

  • Herlev and Gentofte Hospital

    Herlev, Capital Region, 2730, Denmark

  • Hospital Puerta De Hierro

    Majadahonda, Madrid, 28222, Spain

  • Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcón, Madrid, 28223, Spain

  • Hospital del Mar

    Barcelona, 08003, Spain

  • Hôpital Arnaud de Villeneuve - CHU Montpellier

    Montpellier, 34295, France

  • Istituti Ospedalieri di Cremona

    Cremona, 26100, Italy

  • Istituto Oncologico Veneto IRCCS

    Padova, Veneto, 35128, Italy

  • Istituto Tumori ""Giovanni Paolo II

    Bari, 70124, Italy

  • Jeroen Bosch Hospital

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

  • Klinik Schillerhöhe

    Gerlingen, Baden-Wurttemberg, 70839, Germany

  • Klinikum Köln-Merheim

    Cologne, North Rhine-Westphalia, 51109, Germany

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • New Cross Hospital

    Wolverhampton, West Midlands, WV10 0QP, United Kingdom

  • Odense Universitetshospital

    Odense C, Syd, 5000, Denmark

  • Rigshospitalet

    Copenhagen, Copenhagen, 2100, Denmark

  • Samsung Medical Center

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

  • Seoul National University Bundang Hospital

    Seongnam, Kyǒnggi-do, 13620, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, Korea, 03722, South Korea

  • St. Antonius Ziekenhuis, locatie Nieuwegein

    Nieuwegein, 3435 CM, Netherlands

  • Taichung Veterans General Hospital

    Taichung, 40705, Taiwan

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • Thoraxklinik-Heidelberg gGmbH

    Heidelberg, Baden-Wurttemberg, 69126, Germany

  • Ulsan University Hospital

    Ulsan, Ulsan-Kwangyǒkshi, 44033, South Korea

  • Universitätsklinikum Schleswig-Holstein

    Lübeck, Schleswig-Holstein, 23538, Germany

  • Universitätsklinikum Ulm

    Ulm, Baden-Wurttemberg, 89075, Germany

  • Wythenshawe Hospital

    Wythenshawe, Manchester, M23 9LT, United Kingdom

  • Ziekenhuis Rijnstate

    Arnhem, 6815 AD, Netherlands

  • Ziekenhuis St. Jansdal

    Harderwijk, 3844 DG, Netherlands

More trials for these conditions

Other studies related to the condition(s) this trial covers.