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New drug combo shows promise for Hard-to-Treat lung cancer

NCT ID NCT04538664

Disease control Sponsor: Janssen Research & Development, LLC 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 01, 2026 · Updated 4 times

Summary

This phase 3 study tests whether adding the targeted drug amivantamab to standard chemotherapy helps people with advanced non-small cell lung cancer that has a specific EGFR mutation (exon 20 insertion). About 308 participants will receive either the combination or chemotherapy alone. The main goal is to see if the combination delays cancer growth.

What this could mean

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

Active substance
Amivantamab (a targeted antibody) combined with chemotherapy (carboplatin and pemetrexed)
What this could lead to
If successful, this combination could become a new standard treatment for people with this specific type of lung cancer, potentially slowing disease progression better than chemotherapy alone.
What could go wrong
This is a phase 3 trial, but results are not yet final. The combination may cause more side effects than chemo alone, and not all patients may benefit. It is not a cure.

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

308 people

The number who actually took part.

Started

Oct 2020

Expected to finish

Aug 2027

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: * Participant must have histologically or cytologically confirmed, locally advanced or metastatic, nonsquamous non-small cell lung cancer (NSCLC) with documented primary epidermal growth factor receptor (EGFR) Exon 20ins activating mutation * Participant must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. * Participant must have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Participant must agree to genetic characterization of tumor status through the required pretreatment tumor biopsy (or submission of equivalent archival material), as well as baseline and periodic blood samples for analysis of tumor mutations in the bloodstream * A female participant of childbearing potential must have a negative serum or urine test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study Exclusion Criteria: * Participant has evidence of synchronous NSCLC disease (as suggested by genetic characterization or radiographic appearance) * Participant has untreated brain metastases (a participant with definitively, locally treated metastases who is clinically stable, asymptomatic, and off corticosteroid treatment for at least 2 weeks prior to randomization is eligible) * Participant has history of spinal cord compression that has not been treated definitively with surgery or radiation * Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD, or radiation pneumonitis * Participant has a contraindication to the use of carboplatin or pemetrexed (refer to local prescribing information for each agent). Participant has a history of hypersensitivity to, or cannot take, vitamin B12 or folic acid

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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

  • A O U Sant Orsola Malpighi

    Bologna, 40138, Italy

  • Adana City Hospital

    Adana, 01060, Turkey (Türkiye)

  • Aichi Cancer Center Hospital

    Nagoya, 464 8681, Japan

  • Algemeen Ziekenhuis Delta

    Roeselare, 8800, Belgium

  • Ankara Bilkent City Hospital

    Ankara, 6800, Turkey (Türkiye)

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Asklepios Klinik Gauting GmbH - Asklepios Fachkliniken Munchen-Gauting

    Gauting, 82131, Germany

  • Azienda Ospedaliero Univ. Policlinico Gaspare Rodolico

    Catania, 95123, Italy

  • Basavatarakam Indo-American Hospital

    Hyderabad, 500034, India

  • Bashkir State Medical University

    Ufa, 450083, Russia

  • Başkent University Medical Faculty Adana Application and Research Center

    Adana, 01250, Turkey (Türkiye)

  • Beijing Cancer Hospital

    Beijing, 100142, China

  • Beijing Cancer Hospital Chest Tumor Internal Medicine dept. II

    Beijing, 100142, China

  • Beijing Chest hospital, Capital medical university

    Beijing, 101199, China

  • Bethanien Krankenhaus

    Moers, 47441, Germany

  • Blue Ridge Cancer Care

    Salem, Virginia, 24153, United States

  • CHR Hôpital Calmette

    Lille, 59037, France

  • CHU Bordeaux

    Pessac, 33604, France

  • CHU Nantes - Hopital Nord Laënnec

    Nantes, 44093, France

  • CHU UCL Namur - Site Godinne

    Yvoir, 5530, Belgium

  • Cabrini Medical Centre

    Malvern, 3144, Australia

  • Cancer hospital Chinese Academy of Medical Sciences, Shenzhen Center

    Shenzhen, 518116, China

  • Centre Georges Francois Leclerc

    Dijon, 21000, France

  • Centre Hospitalier Le Mans

    Le Mans, 72037, France

  • Centro Hospitalar Universitario do Porto, EPE

    Porto, 4099-001, Portugal

  • Centro Hospitalar de Vila Nova de Gaia Espinho E P E

    Vila Nova de Gaia, 4434 502, Portugal

  • Centro Oncologico de Chihuahua

    Chihuahua City, 31217, Mexico

  • Centrum Onkologii im Prof F Lukaszczyka

    Bydgoszcz, 85 796, Poland

  • Cetus Oncologia

    Belo Horizonte, 30110-017, Brazil

  • Chang Gung Medical Foundation

    Kaohsiung City, 833, Taiwan

  • China Medical University Hospital

    Taichung, 40447, Taiwan

  • Chinese PLA General Hospital

    Beijing, 100853, China

  • Chongqing University Cancer Hospital

    Chongqing, 400030, China

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 58128, South Korea

  • Chris O'Brien Lifehouse

    Camperdown, 2050, Australia

  • Chung Shan Medical University Hospital

    Taichung, 402, Taiwan

  • City Clinical Hospital #1

    Nal'chik, 360000, Russia

  • City of Hope 2

    Duarte, California, 91010, United States

  • Clinica Univ. de Navarra

    Pamplona, 31008, Spain

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4

    Dnipro, 49102, Ukraine

  • Edinburgh Cancer Centre Western General

    Edinburgh, EH4 2XU, United Kingdom

  • Ehime University Hospital

    Toon-shi, 791-0295, Japan

  • Evangelische Lungenklinik Berlin

    Berlin, 13125, Germany

  • Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz

    Székesfehérvár, 8000, Hungary

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

    Milan, 20122, Italy

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133, Italy

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032, China

  • Fujian Medical University Union Hospital

    Fuzhou, 350001, China

  • Fundacao Antonio Prudente A C Camargo Cancer Center

    São Paulo, 01509 900, Brazil

  • Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo

    São Paulo, 01246 000, Brazil

  • Fundacao Pio XII

    Barretos, 14784-400, Brazil

  • Gazi University Hospital

    Ankara, 6560, Turkey (Türkiye)

  • Georgetown University Hospital

    Washington D.C., District of Columbia, 20007, United States

  • Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi

    Istanbul, 34722, Turkey (Türkiye)

  • GyeongSang National University Hospital

    Gyeongsangnam-do, 52727, South Korea

  • H. Lee Moffitt Cancer & Research Institute

    Tampa, Florida, 33612, United States

  • HCG Manavta Cancer Centre

    Nashik, 422002, India

  • HIA Begin

    Saint-Mandé, 94163, France

  • Hadassah Medical Center

    Jerusalem, 9112001, Israel

  • Harbin medical university cancer hospital

    Harbin, 150000, China

  • Health Pharma Professional Research

    México, 03100, Mexico

  • Henan Cancer Hospital

    Zhengzhou, 450008, China

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Hokkaido University Hospital

    Sapporo, 060-8648, Japan

  • Hosp Univ A Coruna

    A Coruña, 15006, Spain

  • Hosp Univ Vall D Hebron

    Barcelona, 08035, Spain

  • Hosp Virgen de La Victoria

    Málaga, 29010, Spain

  • Hosp. Clinico Univ. Lozano Blesa

    Zaragoza, 50009, Spain

  • Hosp. Cuf Descobertas

    Lisbon, 1998-018, Portugal

  • Hosp. Gral. Univ. Gregorio Maranon

    Madrid, 28007, Spain

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041, Spain

  • Hosp. Univ. La Paz

    Madrid, 28046, Spain

  • Hosp. Univ. Pta. de Hierro Majadahonda

    Majadahonda, 28222, Spain

  • Hosp. Univ. Quiron Dexeus

    Barcelona, 08028, Spain

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034, Spain

  • Hosp. Univ. de Burgos

    Burgos, 09003, Spain

  • Hosp. Virgen Del Rocio

    Seville, 41013, Spain

  • Hosp. de La Santa Creu I Sant Pau

    Barcelona, 08025, Spain

  • Hospices Civils de Lyon HCL

    Bron, 69500, France

  • Hospital Civil de Guadalajara Fray Antonio Alcalde

    Guadalajara, 44280, Mexico

  • Hospital Evangélico de Cachoeiro de Itapemirim

    Vitória, 29308-014, Brazil

  • Hospital Kuala Lumpur

    Kuala Lumpur, 50586, Malaysia

  • Hospital Pulau Pinang

    George Town, 10990, Malaysia

  • Hospital Sultan Ismail

    Johor Bahru, 81100, Malaysia

  • Hospital of Jiangnan University

    Wuxi, 214122, China

  • Hunan Cancer Hospital Chest Tumor Internal Medicine dept. II

    Changsha, 410013, China

  • Hunan Cancer hospital

    Changsha, 410013, China

  • IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado

    Sorocaba, 18030-075, Brazil

  • IRCCS Ospedale San Raffaele

    Milan, 20132, Italy

  • Inje University Haeundae Paik Hospital

    Busan, 48108, South Korea

  • Inst. Cat. D'Oncologia-Badalona

    Badalona, 08916, Spain

  • Institut Bergonie

    Bordeaux, 33000, France

  • Institut Curie

    Paris, 75005, France

  • Instituto D Or de Pesquisa e Ensino IDOR

    Rio de Janeiro, 22281 100, Brazil

  • Instituto Nacional de Cancerologia

    Mexico City, 14080, Mexico

  • Instituto Portugues de Oncologia

    Porto, 4200-072, Portugal

  • Irccs Gemelli

    Roma, 00168, Italy

  • Irkutsk Regional Oncology Dispensary

    Irkutsk, 664035, Russia

  • Irmandade Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, 90020-090, Brazil

  • Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali Medikal Onkoloji Bd

    Istanbul, 34098, Turkey (Türkiye)

  • Istituto Clinico Humanitas

    Rozzano, 20089, Italy

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

    Meldola, 47014, Italy

  • Iwate Medical University Hospital

    Shiwa-gun, 028-3695, Japan

  • Izmir Medical Park Hospital

    Izmir, 35580, Turkey (Türkiye)

  • Jilin cancer hospital

    Changchun, 130000, China

  • Juntendo University Hospital

    Bunkyō City, 113 8431, Japan

  • Kanazawa University Hospital

    Kanazawa, 920 8641, Japan

  • Kangbuk Samsung Hospital

    Seoul, 03181, South Korea

  • Kansai Medical University Hospital

    Hirakata, 573 1191, Japan

  • Kaohsiung Medical University Chung Ho Memorial Hospital

    Kaohsiung City, 807, Taiwan

  • Kindai University Hospital

    Osaka Sayama Shi, 589 8511, Japan

  • Kishiwada City Hospital

    Kishiwada, 596-8501, Japan

  • Kitasato University Hospital

    Sagamihara, 252-0375, Japan

  • Kliniken der Stadt Koeln gGmbH

    Cologne, 51109, Germany

  • Kobe City Medical Center General Hospital

    Kobe, 650-0047, Japan

  • Korea University Anam Hospital

    Seoul, 02841, South Korea

  • Krasnoyarsk Regional Oncology Dispensary

    Krasnoyarsk, 660133, Russia

  • Kurashiki Central Hospital

    Kurashiki, 710-8602, Japan

  • Kurume University Hospital

    Kurume, 830-0011, Japan

  • Langone Health at NYC University, NYU School of Medicine

    New York, New York, 10016, United States

  • Leningrad Regional Clinical Hospital

    Saint Petersburg, 194291, Russia

  • Leningrad Regional Oncology Dispensary

    Kuzmolovsky, 188663, Russia

  • Liga Norte Riograndense Contra O Cancer

    Natal, 59062 000, Brazil

  • MCK

    Moscow, 115533, Russia

  • Markusovszky Egyetemi Oktatokorhaz

    Szombathely, 9700, Hungary

  • Matsusaka Municipal Hospital

    Matsusaka, 515-8544, Japan

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1, Canada

  • Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies'

    Kyiv, 02091, Ukraine

  • Medipol Mega University Hospital

    Istanbul, 34214, Turkey (Türkiye)

  • Meir Medical Center

    Kfar Saba, 44281, Israel

  • Mexico Centre for Clinical Research, S.A. de C.V.

    Mexico City, 03100, Mexico

  • Ministerio da Saude Instituto Nacional do Cancer

    Rio de Janeiro, 20231 050, Brazil

  • Moscow City Oncology Hospital № 62

    Krasnogorsk, 143423, Russia

  • Mátrai Gyógyintézet-Bronchológia

    Gyöngyös, 3233, Hungary

  • Médica Sur

    Mexico City, 14050, Mexico

  • N.N. Petrov Research Institute Of Oncology

    Saint Petersburg, 197758, Russia

  • Nanjing Drum Tower Hospital

    Nanjing, 210031, China

  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

    Warsaw, 02-781, Poland

  • National Cancer Center 1

    Gyeonggi-do, 10408, South Korea

  • National Cancer Center Hospital East

    Kashiwa, 277 8577, Japan

  • National Cancer Institute

    Kyiv, 03022, Ukraine

  • National Hospital Organization Himeji Medical Center

    Himeji, 670-8520, Japan

  • National Hospital Organization Nagoya Medical Center

    Nagoya, 460-0001, Japan

  • National Hospital Organization Yamaguchi Ube Medical Center

    Yamaguchi, 755-0241, Japan

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • Niigata Cancer Center Hospital

    Niigata, 951-8566, Japan

  • Nizhny Novgorod Regional Oncological Dispensary

    Nizhny Novgorod, 603000, Russia

  • Noble Hospital Pvt Ltd

    Pune, 411013, India

  • Núcleo de Pesquisa São Camilo

    São Paulo, 04014-002, Brazil

  • Oncoclinicas Rio de Janeiro S A

    Rio de Janeiro, 22 250 905, Brazil

  • Oncologia Integral Satelite

    Naucalpan, 53100, Mexico

  • Oncologianova GmbH

    Recklinghausen, 45659, Germany

  • Oncology Medical Clinics AV Medical group

    Saint Petersburg, 196006, Russia

  • Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda

    Ijuí, 98700-000, Brazil

  • Onkologische Schwerpunktpraxis

    Heilbronn, 74072, Germany

  • Orszagos Koranyi Tbc es Pulmonologiai Intezet

    Budapest, H-1529, Hungary

  • Ospedale S. Maria Delle Croci

    Ravenna, 48121, Italy

  • Pan American Center for Oncology Trials LLC

    Rio Piedras, 00935, Puerto Rico

  • Peking University International Hospital

    Beijing, 102206, China

  • Phramongkutklao Hospital and Medical College

    Bangkok, 10400, Thailand

  • Pius-Hospital Oldenburg

    Oldenburg, 26121, Germany

  • Private Specialist Hospitals - MedPolonia

    Poznan, 60-693, Poland

  • Providence Portland Medical Center

    Portland, Oregon, 97213, United States

  • Rabin Medical Center

    Petah Tikva, 49100, Israel

  • Rajiv Gandhi Cancer Institute & Research Centre

    New Delhi, 110085, India

  • Regional Cancer Care Associates LLC

    East Brunswick, New Jersey, 08816, United States

  • Saitama Medical University International Medical Center

    Hidaka, 350-1298, Japan

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • San Gerardo Hospital

    Monza, 20052, Italy

  • Sanford Health

    Sioux Falls, South Dakota, 57104, United States

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620, South Korea

  • Severance Hospital Yonsei University Health System

    Seoul, 03722, South Korea

  • Shaare Zedek Medical Center

    Jerusalem, 91031, Israel

  • Shanghai Chest Hospital

    Shanghai, 200030, China

  • Shanghai East Hospital

    Shanghai, 200123, China

  • Shanghai Pulmonary Hospital

    Shanghai, 200433, China

  • Shengjing Hospital Of China Medical University

    Shenyang, 110004, China

  • Shizuoka Cancer Center

    Shizuoka, 411 8777, Japan

  • Sir Charles Gairdner Hospital

    Nedlands, 6009, Australia

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou, 310016, China

  • Siriraj Hospital

    Bangkok, 10700, Thailand

  • Songklanagarind Hospital, Prince of Songkla University

    Songkhla, 90110, Thailand

  • St George Hospital

    Kogarah, 2217, Australia

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5, Canada

  • Szpitale Pomorskie Sp z o o

    Gdynia, 81 519, Poland

  • Taipei Medical University Shuang Ho Hospital

    New Taipei City, 23561, Taiwan

  • Taizhou Hospital of Zhejiang Province

    Linhai, 317000, China

  • Tata Medical Center

    Kolkata, 700160, India

  • Tata Memorial Hospital

    Mumbai, 400012, India

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906, Israel

  • Texas Oncology Pa

    Tyler, Texas, 75702, United States

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135 8550, Japan

  • The Catholic University of Korea Seoul St Mary s Hospital

    Seoul, 06591, South Korea

  • The First Affiliated Hospital Sun Yat sen University

    Guangzhou, 510080, China

  • The First Affiliated Hospital Zhejiang University College of Medicine

    Hangzhou, 310003, China

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi'an, 710061, China

  • The First People's Hospital Of Changzhou

    Changzhou, 213003, China

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario, K1H 8L6, Canada

  • The Royal Marsden NHS Trust Chelsea

    London, SW3 6JJ, United Kingdom

  • The Royal Marsden NHS Trust Sutton

    Sutton, SM2 5PT, United Kingdom

  • The Second Affiliated Hospital of Zhejiang University College of Medicine

    Hangzhou, 310009, China

  • The Second Affiliated Hospital of Zhejiang University College of Medicine 1

    Hangzhou, 310009, China

  • Thoraxklinik am Universitatsklinikum Heidelberg

    Heidelberg, 69126, Germany

  • Tianjin Medical University General Hospital

    Tianjin, 300052, China

  • Tomsk Cancer Research Institute

    Tomsk, 634050, Russia

  • TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology

    Wuhan, 430030, China

  • Trakya University Medical Faculty

    Edirne, 22030, Turkey (Türkiye)

  • Tudogyogyintezet Torokbalint

    Törökbálint, 2045, Hungary

  • UCLA

    Santa Monica, California, 90404, United States

  • UPCO Unidade de Pesquisa Clinica em Oncologia

    Pelotas, 96020 080, Brazil

  • UZ Leuven

    Leuven, 3000, Belgium

  • Uls Sao Jose - Hosp. Sto Antonio Dos Capuchos

    Lisbon, G1R 2J6, Portugal

  • Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS

    Porto Alegre, 90610-000, Brazil

  • Universitaetsklinikum Koeln

    Cologne, 50937, Germany

  • University Cancer And Blood Center LLC

    Athens, Georgia, 30607, United States

  • University Malaya Medical Centre

    Kuala Lumpur, 59100, Malaysia

  • University of California Irvine

    Orange, California, 92868, United States

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80 214, Poland

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84106, United States

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031, United States

  • Wakayama Medical University Hospital

    Wakayama, 641 8510, Japan

  • Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie

    Olsztyn, 10-357, Poland

  • Washington University Medical Center

    St Louis, Missouri, 63110, United States

  • Weifang People's Hospital

    Weifang, 261000, China

  • West China Hospital Sichuan University

    Chengdu, 610041, China

  • Yantai Yuhuangding Hospital

    Yantai, 264000, China

  • Yaroslavl Regional Clinical Oncology Hospital

    Yaroslavl, 150054, Russia

  • Ynova Pesquisa Clinica

    Florianópolis, 88020-210, Brazil

  • Zentralklinik Bad Berka GmbH

    Bad Berka, 99437, Germany

  • Zhejiang Cancer Hospital

    Hangzhou, 310022, China

  • i Can Oncology Center

    Monterrey, 64710, Mexico

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