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New hope for lung cancer patients whose current drug stops working

NCT ID NCT05261399

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 07, 2026 · Updated 2 times

Summary

This study tests whether adding savolitinib to osimertinib works better than chemotherapy for people with a certain type of advanced lung cancer (EGFR-mutated, MET-positive) that has stopped responding to osimertinib. About 345 adults will be randomly assigned to receive either the drug combo or chemotherapy. The main goal is to see how long the cancer stays under control.

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

341 people

The number who actually took part.

Started

Aug 2022

Expected to finish

Nov 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 to 130 years

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: * Provision of signed and dated written ICF prior to any mandatory and non-mandatory study-specific procedures, sampling and analyses. * Participant must be ≥18 years (≥ 19 years of age in South Korea) at the time of signing the informed consent. All genders are permitted. * Histologically or cytologically confirmed locally advanced or metastatic NSCLC which is not amenable to curative therapy. * Must have at least one documented sensitising EGFR mutation: exon19 deletion, L858R mutation, and/or T790M. * Documented radiologic progression on first- or second-line treatment with osimertinib as the most recent anti-cancer therapy. * Mandatory provision of FFPE tumour tissue. * MET overexpression and/or amplification in tumour specimen collected following progression on prior osimertinib treatment. * Measurable disease as defined by RECIST 1.1. * Adequate haematological, liver, renal and cardiac functions, and coagulation parameters. * ECOG performance status of 0 or 1. Exclusion Criteria: * Predominant squamous NSCLC, and small cell lung cancer. * Prior or current treatment with a third-generation EGFR-TKI other than Osimertinib. * Prior or current treatment with savolitinib or another MET inhibitors. * Spinal cord compression or brain metastases, unless asymptomatic and are stable. * History or active leptomeningeal carcinomatosis. * Unresolved toxicities from any prior therapy greater than CTCAE Grade 1 and prior platinum-therapy related Grade 2 neuropathies with the exception of alopecia and haemoglobin ≥ 9.0 g/dL. * Active/unstable cardiac diseases currently or within the last 6 months, clinically significant ECG abnormalities, and/or factors/medications that may affect QTc intervals. * History of liver cirrhosis of any origin and clinical stage; or history of other serious liver disease or chronic disease with relevant liver involvement. * Known serious active infection including, but not limited to, tuberculosis, or HIV, HBV or HCV or gastrointestinal disease. * Receipt of live attenuated vaccine (including against COVID-19) within 30 days prior to the first dose of study intervention. * Past medical history of ILD, drug-induced ILD, radiation pneumonitis, which required steroid treatment, or any evidence of clinically active ILD. * Participants currently receiving medications or herbal supplements known to be strong inducers of cytochrome P450 (CYP)3A4 or strong inhibitors of CYP1A2.

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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

  • Research Site

    Orlando, Florida, 32804, United States

  • Research Site

    Honolulu, Hawaii, 96819, United States

  • Research Site

    New Brunswick, New Jersey, 08903, United States

  • Research Site

    New York, New York, 10032, United States

  • Research Site

    Nashville, Tennessee, 37232, United States

  • Research Site

    Buenos Aires, C1125ABD, Argentina

  • Research Site

    CABA, C1019ABS, Argentina

  • Research Site

    Florida, B1602DQD, Argentina

  • Research Site

    La Rioja, F5300COE, Argentina

  • Research Site

    Rosario, 2000, Argentina

  • Research Site

    Rosario, 2123, Argentina

  • Research Site

    San Miguel de Tucumán, 4000, Argentina

  • Research Site

    Viedma, R8500ACE, Argentina

  • Research Site

    Fremantle, 6160, Australia

  • Research Site

    Southport, 4215, Australia

  • Research Site

    Waratah NSW, 2298, Australia

  • Research Site

    Westmead, 2145, Australia

  • Research Site

    Brussels, 1000, Belgium

  • Research Site

    Ghent, 9000, Belgium

  • Research Site

    Roeselare, 8800, Belgium

  • Research Site

    Belo Horizonte, 30110-022, Brazil

  • Research Site

    Cachoeiro de Itapemirim, 29308-014, Brazil

  • Research Site

    Ijuí, 98700-000, Brazil

  • Research Site

    Porto Alegre, 90035-903, Brazil

  • Research Site

    Porto Alegre, 90050-170, Brazil

  • Research Site

    Salvador, 41253-190, Brazil

  • Research Site

    Salvador, 41950-610, Brazil

  • Research Site

    São Paulo, 04014-002, Brazil

  • Research Site

    São Paulo, 04538-132, Brazil

  • Research Site

    São Paulo, 04556-100, Brazil

  • Research Site

    Vitória, 29043-260, Brazil

  • Research Site

    Toronto, Ontario, M4N 3M5, Canada

  • Research Site

    Toronto, Ontario, M5G 2M9, Canada

  • Research Site

    Montreal, Quebec, H3T 1E2, Canada

  • Research Site

    Montreal, Quebec, H3T 1M5, Canada

  • Research Site

    Santiago, 7500713, Chile

  • Research Site

    Baoding, 71030, China

  • Research Site

    Beijing, 100036, China

  • Research Site

    Beijing, 101149, China

  • Research Site

    Bengbu, 233004, China

  • Research Site

    Changchun, 130012, China

  • Research Site

    Changsha, 410011, China

  • Research Site

    Changsha, 41003, China

  • Research Site

    Chengdu, 610041, China

  • Research Site

    Chongqing, 400016, China

  • Research Site

    Fuzhou, 350001, China

  • Research Site

    Fuzhou, 350011, China

  • Research Site

    Hangzhou, 310022, China

  • Research Site

    Harbin, 150040, China

  • Research Site

    Hefei, 230031, China

  • Research Site

    Jinan, 250022, China

  • Research Site

    Linyi, 276000, China

  • Research Site

    Nanchang, 330006, China

  • Research Site

    Qingdao, 266035, China

  • Research Site

    Shanghai, 200030, China

  • Research Site

    Shenyang, 110001, China

  • Research Site

    Shenzhen, 518020, China

  • Research Site

    Wuhan, 430022, China

  • Research Site

    Wuhan, 430079, China

  • Research Site

    Xi'an, 710061, China

  • Research Site

    Xi'an, 710100, China

  • Research Site

    Xiangfan, 441021, China

  • Research Site

    Yichang, 443003, China

  • Research Site

    Zhengzhou, 450008, China

  • Research Site

    Bobigny, 93000, France

  • Research Site

    Brest, 29200, France

  • Research Site

    Créteil, 94010, France

  • Research Site

    Dijon, 21079, France

  • Research Site

    Marseille, 13915, France

  • Research Site

    Paris, 75005, France

  • Research Site

    Poitiers, 86021, France

  • Research Site

    Rennes, 35033, France

  • Research Site

    Rouen, 76000, France

  • Research Site

    Saint-Herblain, 44800, France

  • Research Site

    Saint-Quentin, 02321, France

  • Research Site

    Strasbourg, 67091, France

  • Research Site

    Suresnes, 92151, France

  • Research Site

    Berlin, 14165, Germany

  • Research Site

    Chemnitz, 09113, Germany

  • Research Site

    Frankfurt A. Main, 60590, Germany

  • Research Site

    Gauting, 82131, Germany

  • Research Site

    Immenhausen, 34376, Germany

  • Research Site

    Löwenstein, 74245, Germany

  • Research Site

    München, 81925, Germany

  • Research Site

    Münster, 48149, Germany

  • Research Site

    Wangen, 88239, Germany

  • Research Site

    Athens, 115 27, Greece

  • Research Site

    Athens, 11527, Greece

  • Research Site

    Chaïdári, 124 62, Greece

  • Research Site

    Heraklion, 71110, Greece

  • Research Site

    Larissa, 41110, Greece

  • Research Site

    Rio, 265 04, Greece

  • Research Site

    Thessaloniki, 546 39, Greece

  • Research Site

    Thessaloniki, 54622, Greece

  • Research Site

    Hong Kong, 999077, Hong Kong

  • Research Site

    Kowloon, Hong Kong

  • Research Site

    Afula, 18341, Israel

  • Research Site

    Ashdod, 7747629, Israel

  • Research Site

    Be’er Ya‘aqov, 70300, Israel

  • Research Site

    Hadera, 38100, Israel

  • Research Site

    Jerusalem, 91031, Israel

  • Research Site

    Tel Aviv, 6423906, Israel

  • Research Site

    Avellino, 83100, Italy

  • Research Site

    Aviano, 33081, Italy

  • Research Site

    Catania, 95123, Italy

  • Research Site

    Meldola, 47014, Italy

  • Research Site

    Milan, 20133, Italy

  • Research Site

    Milan, 20141, Italy

  • Research Site

    Modena, 41124, Italy

  • Research Site

    Monserrato, 09042, Italy

  • Research Site

    Naples, 80138, Italy

  • Research Site

    Orbassano, 10043, Italy

  • Research Site

    Padova, 35128, Italy

  • Research Site

    Parma, 43126, Italy

  • Research Site

    Perugia, 6124, Italy

  • Research Site

    Peschiera del Garda, 37019, Italy

  • Research Site

    Roma, 00144, Italy

  • Research Site

    Roma, 00152, Italy

  • Research Site

    Treviso, 31100, Italy

  • Research Site

    Bunkyō City, 113-8603, Japan

  • Research Site

    Chūōku, 104-0045, Japan

  • Research Site

    Fukuoka, 812-8582, Japan

  • Research Site

    Hirosaki-shi, 036-8563, Japan

  • Research Site

    Hiroshima, 730-8518, Japan

  • Research Site

    Iwakuni-shi, 740-8510, Japan

  • Research Site

    Kanazawa, 920-8641, Japan

  • Research Site

    Kashiwa, 277-8577, Japan

  • Research Site

    Kobe, 650-0017, Japan

  • Research Site

    Kobe, 650-0046, Japan

  • Research Site

    Kumamoto, 860-8556, Japan

  • Research Site

    Kurume-shi, 830-0011, Japan

  • Research Site

    Nagasaki, 852-8501, Japan

  • Research Site

    Okayama, 700-8558, Japan

  • Research Site

    Osaka, 534-0021, Japan

  • Research Site

    Osakasayama-shi, 589-8511, Japan

  • Research Site

    Sakaishi, 591-8555, Japan

  • Research Site

    Sapporo, 003-0804, Japan

  • Research Site

    Sapporo, 060-8638, Japan

  • Research Site

    Sendai, 980-0873, Japan

  • Research Site

    Sunto-gun, 411-8777, Japan

  • Research Site

    Utsunomiya, 320-0834, Japan

  • Research Site

    Wakayama, 641-8510, Japan

  • Research Site

    Yokohama, 241-8515, Japan

  • Research Site

    Kota Bharu, 15586, Malaysia

  • Research Site

    Kuala Lumpur, 59100, Malaysia

  • Research Site

    Petaling Jaya, 47500, Malaysia

  • Research Site

    Pulau Pinang, 10990, Malaysia

  • Research Site

    Sabak Bernam, 88996, Malaysia

  • Research Site

    Bacolod, 6100, Philippines

  • Research Site

    Davao City, 8000, Philippines

  • Research Site

    Manila, 1000, Philippines

  • Research Site

    Quezon City, 1100, Philippines

  • Research Site

    Quezon City, 1112, Philippines

  • Research Site

    San Juan City, 1502, Philippines

  • Research Site

    Lodz, 93-338, Poland

  • Research Site

    Olsztyn, 10-357, Poland

  • Research Site

    Singapore, 169610, Singapore

  • Research Site

    Singapore, 308433, Singapore

  • Research Site

    Goyang-si, 10408, South Korea

  • Research Site

    Gyeonggi-do, 13620, South Korea

  • Research Site

    Jinju, 660-702, South Korea

  • Research Site

    Seoul, 06273, South Korea

  • Research Site

    Seoul, 06351, South Korea

  • Research Site

    Seoul, 08308, South Korea

  • Research Site

    Seoul, 138-736, South Korea

  • Research Site

    Seoul, 6591, South Korea

  • Research Site

    Suwon, 16247, South Korea

  • Research Site

    Badajoz, 6006, Spain

  • Research Site

    Badalona, 8916, Spain

  • Research Site

    Barcelona, 08036, Spain

  • Research Site

    Barcelona, 8035, Spain

  • Research Site

    Córdoba, 14004, Spain

  • Research Site

    Girona, 17007, Spain

  • Research Site

    Madrid, 28040, Spain

  • Research Site

    Madrid, 28041, Spain

  • Research Site

    Majadahonda, 28222, Spain

  • Research Site

    Málaga, 29010, Spain

  • Research Site

    Pontevedra, 36312, Spain

  • Research Site

    Sabadell, 08208, Spain

  • Research Site

    Seville, 41009, Spain

  • Research Site

    Valencia, 46026, Spain

  • Research Site

    Zaragoza, 50009, Spain

  • Research Site

    Baden, CH-5405, Switzerland

  • Research Site

    Zurich, 8063, Switzerland

  • Research Site

    Chiayi City, 62247, Taiwan

  • Research Site

    Hsinchu, 300, Taiwan

  • Research Site

    Kaohsiung City, 83301, Taiwan

  • Research Site

    Liuying, 736, Taiwan

  • Research Site

    Taichung, 404, Taiwan

  • Research Site

    Taichung, 40705, Taiwan

  • Research Site

    Taipei, 100, Taiwan

  • Research Site

    Taipei, 11259, Taiwan

  • Research Site

    Taipei, 112, Taiwan

  • Research Site

    Bangkok, 10210, Thailand

  • Research Site

    Bangkok, 10700, Thailand

  • Research Site

    Chanthaburi, 22000, Thailand

  • Research Site

    Chiang Mai, 50200, Thailand

  • Research Site

    Dusit, 10300, Thailand

  • Research Site

    Hat Yai, 90110, Thailand

  • Research Site

    Muang, 40002, Thailand

  • Research Site

    Adana, 1370, Turkey (Türkiye)

  • Research Site

    Ankara, 6800, Turkey (Türkiye)

  • Research Site

    Edirne, 22030, Turkey (Türkiye)

  • Research Site

    Istanbul, 34214, Turkey (Türkiye)

  • Research Site

    Istanbul, 34722, Turkey (Türkiye)

  • Research Site

    Izmir, 35100, Turkey (Türkiye)

  • Research Site

    London, SE1 9RT, United Kingdom

  • Research Site

    Manchester, M20 4BX, United Kingdom

  • Research Site

    Wolverhampton, WV10 0QP, United Kingdom

  • Research Site

    Can Tho, 900000, Vietnam

  • Research Site

    Hanoi, 100000, Vietnam

  • Research Site

    Hanoi, 10000, Vietnam

  • Research Site

    Ho Chi Minh City, 700000, Vietnam

  • Research Site

    Ho Chi Minh City, 70000, Vietnam

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