New hope for KRAS lung cancer: targeted pill tested in phase 3 trial
NCT ID NCT02152631
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 3 study tests whether the targeted drug abemaciclib can help people with stage IV lung cancer that has a KRAS mutation and has worsened after chemotherapy. About 450 participants received either abemaciclib or another targeted drug (erlotinib), both alongside best supportive care. The main goal is to see if abemaciclib helps people live longer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- abemaciclib (a targeted cancer pill)
- What this could lead to
- If it works, this could offer a new treatment option for people with a specific type of advanced lung cancer that has stopped responding to chemotherapy.
- What could go wrong
- This is a late-stage trial, but the drug may not improve survival compared to the current standard. Side effects from targeted therapies can be serious.
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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453 people
The number who actually took part.
- Started
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Oct 2014
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Have confirmed diagnosis of stage IV non-small cell lung cancer (NSCLC) according to the American Joint Committee on Cancer Staging Handbook. * Determined to have detectable mutations in codons 12 or 13 of the kirsten rat sarcoma (KRAS) oncogene by an investigational assay at the study central laboratory. A KRAS positive mutation result in codons 12 or 13 of the KRAS oncogene from tumor tissue per local laboratory will be permitted in no more than 10% of randomized participants. * Have progressed after platinum-based chemotherapy (with or without maintenance therapy) AND have received one additional therapy which may include an immune checkpoint inhibitor or other anti-cancer therapy for advanced and/or metastatic disease OR is judged by the physician as ineligible for further standard second-line chemotherapy. Participants who have progressed after platinum-based chemotherapy and an immune checkpoint inhibitor (immunotherapy) e.g. pembrolizumab or nivolumab alone or in combination with other agents are eligible. * Have measureable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). * Have a performance status (PS) of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) scale. * Have discontinued all previous therapies for cancer (including chemotherapy, radiotherapy, immunotherapy, and investigational therapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug. Exclusion Criteria: * Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively. * Have a personal history of any of the following conditions: presyncope or syncope of either unexplained or cardiovascular etiology, ventricular arrhythmia (including but not limited to ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest. * Have the presence of unstable central nervous system (CNS) metastasis. History of CNS metastasis or stable CNS metastases is allowed (no longer requiring active therapy such as steroid medications). Participants with a history of CNS metastases must have a brain scan (for example, magnetic resonance imaging \[MRI\]) within 28 days of randomization to document stability, even if there have been no changes in symptoms. * Have previously completed or withdrawn from this study or any other study investigating a cyclin-dependent kinase 4 (CDK4) and cyclin-dependent kinase 6 (CDK6) inhibitors, or have received treatment with a prior CDK4 and CDK6 inhibitors.
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Get notified about this study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Alegent Immanuel Cancer Center
Englewood, Colorado, 80112, United States
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Arkhangelsk Regional Clinical Oncology Dispensary
Arkhangelsk, 163045, Russia
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Associação Hospital de Caridade Ijuí
Ijuí, 98700 000, Brazil
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Billings Clinic Research Center
Billings, Montana, 59101, United States
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Boca Raton Regional Hospital
Boca Raton, Florida, 33486, United States
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Broome Oncology
Johnson City, New York, 13790, United States
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CBCC Global Research, Inc.
Los Angeles, California, 90024, United States
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Cancer Care Associates Medical Group
Los Angeles, California, 90095, United States
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Cancer Care Northwest
Valley, Washington, 99216, United States
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Cancer Center of Kansas, P.A.
Wichita, Kansas, 67214, United States
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Central Baptist Hospital
Lexington, Kentucky, 40503, United States
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Central Coast Medical Oncology Corporation
Los Angeles, California, 90024, United States
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Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, 37404, United States
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Chattanooga Oncology Hematology Associates
Nashville, Tennessee, 37203, United States
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City of Hope National Medical Center
Duarte, California, 91010, United States
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Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
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Dignity Health Care Institute
Sacramento, California, 95816, United States
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Berazategui, B1884BBF, Argentina
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Rosario, S2000DSV, Argentina
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Linz, 4020, Austria
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São Paulo, 01246000, Brazil
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Beijing, 100021, China
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Beijing, 100730, China
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Dijon, 21034, France
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Saint-Brieuc, 22027, France
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Ciudad Autonoma Buenos Aires, 1025, Argentina
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Ciudad Autonoma Buenos Aires, 1093, Argentina
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Ciudad Autonoma Buenos Aires, C1181AAX, Argentina
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Rosario, 2000, Argentina
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Viedma, 8500, Argentina
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Graz, 8036, Austria
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Linz, 4021, Austria
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Salzburg, 5020, Austria
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Porto Alegre, 90610-970, Brazil
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Rio de Janeiro, 20231-050, Brazil
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Salvador, 41253-190, Brazil
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Sao Jose Rio Preto, 15090-000, Brazil
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Beijing, 100071, China
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Changchun, 130012, China
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Changzhou, 213000, China
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Chengdu, 610041, China
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Haikou, 570311, China
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Hangzhou, 310022, China
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Hefei, 230001, China
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Nanning, 530021, China
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Shanghai, 200030, China
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Shenyang, 100042, China
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Bron, 69677, France
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Grenoble, 38043, France
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Lille, 59037, France
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Marseille, 13015, France
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Poitiers, 86021, France
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Rennes, 35033, France
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Saint-Priest-en-Jarez, 42270, France
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Toulouse, 31059, France
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Vantoux, 57070, France
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Berlin, 14165, Germany
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Gera, 07548, Germany
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Großhansdorf, 22927, Germany
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Hamburg, 21075, Germany
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Hanover, 30459, Germany
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Heidelberg, 69126, Germany
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Immenhausen, 34376, Germany
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Nuremberg, 90419, Germany
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Regensburg, 93053, Germany
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Rosenheim, 83022, Germany
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Tübingen, 72076, Germany
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Ulm, 89081, Germany
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Athens, 11522, Greece
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Athens, 11527, Greece
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Athens, 18537, Greece
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Heraklion, 71110, Greece
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Pátrai, 26504, Greece
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Holon, 5822012, Israel
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Petah Tikva, 4941492, Israel
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Catania, 95125, Italy
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Genova, 16132, Italy
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Livorno, 57124, Italy
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Parma, 43100, Italy
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Rome, 00152, Italy
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Amagasaki, 660-0892, Japan
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Asahikawa, 070-8644, Japan
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Bunkyō City, 113-8431, Japan
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Bunkyō City, 113-8677, Japan
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Fukuoka, 811-1395, Japan
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Habikino, 583-8588, Japan
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Hirakata, 573-1191, Japan
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Hiroshima, 734-8551, Japan
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Hyōgo, 6608550, Japan
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Kanazawa, 920-8641, Japan
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Kashiwa, 277 8577, Japan
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Kishiwada, 596-8501, Japan
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Kitaadachi-Gun, 362-0806, Japan
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Kobe, 650-0047, Japan
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Kōtoku, 135-8550, Japan
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Kurashiki, 710-8602, Japan
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Matsuyama, 791-0280, Japan
-
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Nagasaki, 852-8501, Japan
-
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Nagoya, 464-8681, Japan
-
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Nagoya, 466-8560, Japan
-
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Natori, 981-1293, Japan
-
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Okayama, 700-8558, Japan
-
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Osaka, 534-0021, Japan
-
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Osaka, 537-8511, Japan
-
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Osaka, 545-8586, Japan
-
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Sakai, 5918555, Japan
-
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Sayama, 589-8511, Japan
-
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Sendai, 980-0873, Japan
-
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Shinjuku-ku, 160-0023, Japan
-
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Sunto-Gun, 411-8777, Japan
-
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Ube, 755-0241, Japan
-
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Utsunomiya, 320-0834, Japan
-
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Wakayama, 641-8510, Japan
-
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Yokohama, 236-0004, Japan
-
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Yonago, 683-0826, Japan
-
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Yufu-shi, 8795593, Japan
-
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Gdansk, 80-219, Poland
-
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Lodz, 90-242, Poland
-
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Olsztyn, 10-357, Poland
-
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Radom, 26-617, Poland
-
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Szczecin, 70-891, Poland
-
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Baia Mare, 430031, Romania
-
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Bucharest, 022328, Romania
-
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Cluj-Napoca, 400015, Romania
-
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Cluj-Napoca, 400058, Romania
-
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Craiova, 200347, Romania
-
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Kursk, 305035, Russia
-
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Goyang-si, 10408, South Korea
-
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Incheon, 21565, South Korea
-
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Seoul, 03722, South Korea
-
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Seoul, 05505, South Korea
-
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Seoul, 06351, South Korea
-
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Seoul, 06591, South Korea
-
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Seowon-Gu, 28644, South Korea
-
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Suwon, 16247, South Korea
-
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Ulsan, 44033, South Korea
-
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A Coruña, 15006, Spain
-
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Barcelona, 08003, Spain
-
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L'Hospitalet de Llobregat, 08907, Spain
-
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Madrid, 28040, Spain
-
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Madrid, 28041, Spain
-
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Madrid, 28050, Spain
-
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Málaga, 29010, Spain
-
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Seville, 41013, Spain
-
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Valencia, 46026, Spain
-
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Chiayi City, 613, Taiwan
-
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Kaohsiung City, 82445, Taiwan
-
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Kaohsiung City, 83301, Taiwan
-
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Taichung, 40447, Taiwan
-
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Taichung, 404, Taiwan
-
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Tainan, 70403, Taiwan
-
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Taipei, 10002, Taiwan
-
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Taipei, 10449, Taiwan
-
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Taipei, 11217, Taiwan
-
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Zhonghe, 235, Taiwan
-
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Ankara, 06100, Turkey (Türkiye)
-
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Ankara, 06490, Turkey (Türkiye)
-
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Antalya, 07059, Turkey (Türkiye)
-
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Edirne, 22030, Turkey (Türkiye)
-
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Istanbul, 34020, Turkey (Türkiye)
-
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Istanbul, 34098, Turkey (Türkiye)
-
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Istanbul, 34890, Turkey (Türkiye)
-
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Izmir, 35100, Turkey (Türkiye)
-
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Dnipropetrovsk, 49102, Ukraine
-
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Kharkiv, 61070, Ukraine
-
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Kryvyi Rih, 50048, Ukraine
-
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Kyiv, 04107, Ukraine
-
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Lutsk, 63000, Ukraine
-
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Poltava, 36011, Ukraine
-
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Sumy, 40005, Ukraine
-
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Uzhhorod, 88000, Ukraine
-
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Vinnitsa, 21029, Ukraine
-
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
Calgary, T2N 4N2, Canada
-
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
Edmonton, T6G 1Z2, Canada
-
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
Montreal, H2L 4M1, Canada
-
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
Toronto, M4N 3M5, Canada
-
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
Vancouver, V5Z 4E6, Canada
-
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
Winnipeg, R3A 1M3, Canada
-
Fort Wayne Oncology & Hematology
Los Angeles, California, 90024, United States
-
Fundação Antonio Prudente - Hospital do Câncer A.C Camargo
São Paulo, 01509-010, Brazil
-
H Lee Moffitt Cancer Center
Tampa, Florida, 33612-9497, United States
-
Hadassah Medical Center - Ein Karem
Jerusalem, 9112001, Israel
-
Halifax Medical Center
Daytona Beach, Florida, 32114, United States
-
Highlands Oncology Group
Fayetteville, Arkansas, 72703, United States
-
Hospital Bruno Born
Lajeados, 95900-000, Brazil
-
Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
-
Ingalls Memorial Hospital
Harvey, Illinois, 60426, United States
-
Jewish Hospital
Englewood, Colorado, 80112, United States
-
Kadlec Clinical Hematology & Oncology
Kennewick, Washington, 99336, United States
-
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
-
Krasnodar regional clinical hospital # 1 n. a. S. V. Ochapovskogo
Krasnodar, 350086, Russia
-
Loma Linda University School of Medicine
Loma Linda, California, 92350, United States
-
Mary Crowley Cancer Research Center
Dallas, Texas, 75230, United States
-
Medical Oncology Hematology Consultants
Newark, Delaware, 19713, United States
-
Meir Medical Center
Kfar Saba, 4428164, Israel
-
Memorial Cancer Institute
Pembroke Pines, Florida, 33028, United States
-
Mercy Medical Research Institute
Springfield, Missouri, 65807, United States
-
Metro-West and Greater Boston CNS Research
Framingham, Massachusetts, 01701, United States
-
Oklahoma Cancer Specialists & Research Institute, LLC
Tulsa, Oklahoma, 74146, United States
-
Oncology Hematology Care Inc
Cincinnati, Ohio, 45242, United States
-
Oncology Hematology West
Englewood, Colorado, 80112, United States
-
Private clinic "Evimed"
Chelyabinsk, 454048, Russia
-
Providence Cancer Center Oncology Hematology Care
Portland, Oregon, 97213, United States
-
Republic clinical oncology dispensary of MoH of Bashkortostan Republic
Ufa, 450054, Russia
-
Roper St. Francis Healthcare
Charleston, South Carolina, 29401, United States
-
Russian oncological scientific centre n.a. N.N. Blokhin of RAMS
Moscow, 115478, Russia
-
SMO Catholic Health Initiatives
Englewood, Colorado, 80112, United States
-
SMO TRIO -Translational Research
Los Angeles, California, 90024, United States
-
Saint-Petersburg city clinical oncology dispensary
Saint Petersburg, 198255, Russia
-
Sheba Medical Center
Tel Litwinsky, 5265601, Israel
-
Soroka Medical Center
Beersheba, 8410101, Israel
-
St Joseph Cancer Center
Englewood, Colorado, 80112, United States
-
St-Petersburg scientifical practical center of specialized kinds of medical care (oncological)
Saint Petersburg, 197758, Russia
-
St. Bernards Medical Center
Jonesboro, Arkansas, 72401, United States
-
St. Francis Medical Center
Englewood, Colorado, 80112, United States
-
St. Joseph Heritage Medical Group
Los Angeles, California, 90024, United States
-
Swedish Medical Center
Seattle, Washington, 98104, United States
-
Tennessee Oncology PLLC
Nashville, Tennessee, 37203, United States
-
UCLA Department of Medicine-Hematology/Oncology
Los Angeles, California, 90024, United States
-
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15213, United States
-
University Cancer & Blood Center, LLC
Athens, Georgia, 30607, United States
-
University of California - San Diego
La Jolla, California, 92037, United States
-
University of Iowa
Iowa City, Iowa, 52242, United States
-
University of Louisville
Louisville, Kentucky, 40202, United States
-
University of Vermont Medical Center
Burlington, Vermont, 05401, United States
-
Utah Cancer Specialists
Salt Lake City, Utah, 84106, United States
-
VA Caribbean Healthcare System
San Juan, 00921-3201, Puerto Rico
-
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
-
Volgograd regional clinical oncology dispensary
Volzhskiy, 404130, Russia
-
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889, United States
-
Weill Cornell Medical College
New York, New York, 10065, United States
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