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New drug cocktail shows promise in slowing EGFR lung cancer

NCT ID NCT02411448

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Phase 3 trial tests whether adding ramucirumab (a drug that blocks blood vessel growth) to the standard targeted therapy erlotinib can help people with a specific type of advanced lung cancer (EGFR-mutated NSCLC) live longer without their cancer getting worse. About 545 people who have not had prior treatment are randomly assigned to receive either the combination or erlotinib alone. The study also explores other drug combinations in certain patient groups. The main goal is to see if the combo delays cancer progression and is safe.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ramucirumab (a blood vessel growth blocker) combined with erlotinib (a targeted cancer pill)
What this could lead to
If successful, this combination could become a new first-line treatment option for people with EGFR-mutated lung cancer, potentially delaying cancer growth longer than erlotinib alone.
What could go wrong
This is a Phase 3 trial, but results are not yet final. Adding ramucirumab may increase side effects like high blood pressure or bleeding without significantly improving outcomes. The benefit may also vary by specific EGFR mutation type.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

545 people

The number who actually took part.

Started

May 2015

Expected to finish

Dec 2026

An estimate. End dates often move.

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: * Cytologically or histologically confirmed diagnosis of Stage IV NSCLC as defined by the American Joint Committee on Cancer Staging Criteria for Lung Cancer (AJCC 7th edition 2009). * Eligible for first-line treatment with erlotinib based on documented evidence of tumor harboring an activating EGFR mutation \[exon 19 deletion or exon 21 (L858R) substitution mutation\]. * Mandatory provision of adequate archived stage IV NSCLC tissue samples or tissue samples other than stage IV NSCLC may be acceptable (optional for part C). * At least one measurable lesion. * Life expectancy of at least 3 months. Exclusion Criteria: * Known T790M EGFR mutation (not applicable for Part C Period 2). * Known leptomeningeal carcinomatosis, uncontrolled/unstable spinal cord compression, or brain metastases. * Serious illness or medical condition. * Ongoing treatment with CYP3A4 inducers or strong inhibitors. * Ongoing therapy with nonsteroidal anti-inflammatory drugs for more than 2 months. * History of gross hemoptysis. * Significant bleeding disorders. * Radiologically documented evidence of major blood vessel invasion or encasement by cancer. * Radiographic evidence of intratumor cavitation. * History of gastrointestinal perforation within last 6 months. * History of bowel obstruction, inflammatory enteropathy or extensive intestinal resection. * History of any arterial thrombotic event within 6 months prior to enrollment. * The participant has any known significant ophthalmologic abnormalities of the surface of the eye.

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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.

Metastatic non-small cell lung cancer

Contacts and locations

Locations

  • AHN Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212, United States

  • Aichi Cancer Center Hospital

    Nagoya, Aichi-ken, 464-8681, Japan

  • Ajou University Hospital

    Suwon, Kyǒnggi-do, 16499, South Korea

  • Asan Medical Center

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

  • Azienda Sanitaria Ospedaliera S Luigi Gonzaga

    Orbassano, Torino, 10043, Italy

  • Baskent University Dr. Turgut Noyan Research and Training Center

    Adana, 1250, Turkey (Türkiye)

  • Cancer Center of Kansas

    Wichita, Kansas, 67214, United States

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers, Vienne, 86021, France

  • Chang Gung Memorial Hospital at Kaohsiung

    Kaohsiung Niao Sung Dist, Kaohsiung, 83301, Taiwan

  • Charing Cross Hospital

    Chelsea, London, W6 8RF, United Kingdom

  • Chiba University Hospital

    Chiba, 260-8677, Japan

  • China Medical University Hospital

    Taichung, 40447, Taiwan

  • Chu Grenoble Alpes

    La Tronche, Isère, 38700, France

  • Chungbuk National University Hospital

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

  • City Hospital, Nottingham University Hospitals

    Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

  • Clinica Universitaria De Navarra

    Pamplona, Navarre, 31008, Spain

  • Cro-Irccs

    Aviano, Friuli Venezia Giulia, 33081, Italy

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2, Canada

  • E-DA Hospital

    Kaohsiung City, 82445, Taiwan

  • Ege Universitesi Hastanesi

    Bornova, İzmir, 35100, Turkey (Türkiye)

  • Ehime University Hospital

    Tōon, Ehime, 791-0295, Japan

  • Foundation for Biomedical Research and innovation

    Kobe, Hyōgo, 650-0047, Japan

  • Gyeongsang National University Hospital

    Jinju, Kyǒngsangnam-do, 52727, South Korea

  • Helios Klinikum Emil von Behring Berlin-Zehlendorf

    Berlin, 14165, Germany

  • Himeji Medical Center

    Himeji, Hyōgo, 670-8520, Japan

  • Hopital Claude Huriez - CHU de Lille

    Lille, Nord, 59037, France

  • Hospital Son Llatzer

    Palma, Illes Balears [Islas Baleares], 07198, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [Barcelona], 08035, Spain

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, Comunidad de, 28041, Spain

  • Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcón, Madrid, 28223, Spain

  • Hospital Universitario Virgen de Valme

    Seville, 41014, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, 41013, Spain

  • Hyogo Cancer Center

    Akashi, Hyōgo, 673-8558, Japan

  • Hyogo Prefectual Amagasaki General Medical Center

    Amagashiki, Hyōgo, 660-8550, Japan

  • Hôpital Arnaud de Villeneuve - CHU Montpellier

    Montpellier, Hérault, 34090, France

  • Hôpital Européen Georges Pompidou

    Paris, 75015, France

  • IRCCS - AOU di Bologna

    Bologna, 40138, Italy

  • Instituto Catalan de Oncologia - Hospital Duran i Reynals

    Hospitalet, Barcelona [Barcelona], 08908, Spain

  • Instituto Tumori Giovanni Paolo II

    Bari, Apulia, 70124, Italy

  • Institutul Oncologic

    Bucharest, Bucharest, 022328, Romania

  • Istituto Oncologico Veneto IRCCS

    Padova, 35128, Italy

  • Japanese Foundation for Cancer Research

    Koto, Tokyo, 135-8550, Japan

  • Juntendo University Hospital

    Tokyo, 113-8431, Japan

  • Kanagawa Cancer Center

    Yokohama, Kanagawa, 241-8515, Japan

  • Kanagawa Cardiovascular and Respiratory Center

    Yokohama, Kanagawa, 236-0051, Japan

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken, 920-8641, Japan

  • Kansai Medical University Hospital

    Hirakata, Osaka, 573-1191, Japan

  • Kindai University Hospital- Osakasayama Campus

    Ōsaka-sayama, Osaka, 589-8511, Japan

  • Kishiwada City Hospital

    Kishiwada, Osaka, 596-8501, Japan

  • Klinikum Chemnitz GmbH

    Chemnitz, Saxony, 09113, Germany

  • Klinikum Köln-Merheim

    Cologne, North Rhine-Westphalia, 51109, Germany

  • Kobe City Medical Center General Hospital

    Kobe, Hyōgo, 650-0047, Japan

  • Korea University Guro Hospital

    Seoul, Seoul-teukbyeolsi [Seoul], 08308, South Korea

  • Kurume University Hospital

    Kurume, Fukuoka, 830-0011, Japan

  • Kyoto University Hospital

    Kyoto, 606-8507, Japan

  • Kyushu University Hospital

    Fukuoka, 812-8582, Japan

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204, United States

  • LungenClinic Grosshansdorf

    Großhansdorf, Schleswig-Holstein, 22927, Germany

  • MacKay Memorial Hospital

    Taipei, 10449, Taiwan

  • Nagasaki University Hospital

    Nagasaki, 852-8501, Japan

  • National Cancer Center Hospital

    Chuo-Ku, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277 8577, Japan

  • National Cheng-Kung University Hospital

    Tainan, 704, Taiwan

  • National Hospital Organization Asahikawa Medical Center

    Asahikawa, Hokkaido, 070-8644, Japan

  • National Hospital Organization Kinki-Chuo Chest Medical Center

    Sakai, Osaka, 5918555, Japan

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1395, Japan

  • National Hospital Organization Kyushu Medical Center

    Fukuoka, 810-8563, Japan

  • National Hospital Organization Yamaguchi Ube Medical Center

    Ube, Yamaguchi, 755-0241, Japan

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • Niigata Cancer Center Hospital

    Niigata, Niigata, 951-8566, Japan

  • Niigata University Medical & Dental Hospital

    Niigata, 951-8520, Japan

  • Nippon Medical School Hospital

    Tokyo, 113-8603, Japan

  • Okayama University Hospital

    Okayama, 700-8558, Japan

  • Osaka City General Hospital

    Osaka, 534-0021, Japan

  • Osaka City University Hospital

    Osaka, 545-8586, Japan

  • Osaka Habikino Medical Center

    Habikino, Osaka, 583-8588, Japan

  • Osaka Medical Center for Cancer and Cardiovascular Diseases

    Osaka, 537-8511, Japan

  • Ospedale San Raffaele

    Milan, 20132, Italy

  • Queen Elizabeth Hospital

    Yau Ma Tei, 999077, Hong Kong

  • Queen Mary Hospital

    Hong Kong, Hong Kong

  • Queens Medical Associates

    Fresh Meadows, New York, 11366, United States

  • Robert-Bosch-Krankenhaus

    Gerlingen, Baden-Wurttemberg, 70839, Germany

  • Royal Marsden Hospital (Chelsea)

    London, Kensington and Chelsea, SW3 6JJ, United Kingdom

  • S.C. MedisProf SRL

    Cluj-Napoca, Cluj, 400058, Romania

  • Saitama Prefectural Cancer Center

    Ina-machi, Saitama, 362-0806, Japan

  • Samsung Medical Center

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

  • Sendai Kousei Hospital

    Sendai, Miyagi, 9800873, Japan

  • Seoul National University Bundang Hospital

    Seongnam, Kyǒnggi-do, 10408, South Korea

  • Shizuoka Cancer Center

    Nakatogari, Shizuoka, 411-8777, Japan

  • Sotiria Thoracic Diseases Hospital of Athens

    Athens, Attikí, 11527, Greece

  • St. Charles Health System

    Denver, Colorado, 80203, United States

  • St. Lukes International Hospital

    Tokyo, 104-8560, Japan

  • Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH

    Halle, Saxony-Anhalt, 06120, Germany

  • Taichung Veterans General Hospital

    Taichung, 40705, Taiwan

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • The Catholic Univ. of Korea Seoul St. Mary's Hospital

    Seoul, Seoul-teukbyeolsi [Seoul], 06591, South Korea

  • The Catholic University Of Korea St. Vincent's Hospital

    Suwon, Kyǒnggi-do, 16247, South Korea

  • The Gastroenterology Group, P.C.

    Honolulu, Hawaii, 96813, United States

  • Thoraxklinik Heidelberg gGmbH

    Heidelberg, Baden-Wurttemberg, 69126, Germany

  • Tokyo Met Cancer & Infectious Diseases Center Komagome Hp

    Bunkyo-ku, Tokyo, 113-8677, Japan

  • Trakya University

    Edirne, 22030, Turkey (Türkiye)

  • UCLA Hematology/Oncology - Santa Monica

    Los Angeles, California, 90404, United States

  • Ulsan University Hospital

    Ulsan, Ulsan-Kwangyǒkshi, 44033, South Korea

  • Wakayama MedicaL University Hospital

    Wakayama, 641-0012, Japan

  • İnönü Üniversitesi Turgut Özal Tıp Merkezi Eğitim ve Araştırma Hastanesi

    Malatya, 44280, Turkey (Türkiye)

More trials for these conditions

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