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New combo aims to outsmart lung cancer resistance

NCT ID NCT06350097

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Updated 2 times

Summary

This phase 3 trial tests whether adding the antibody-drug conjugate datopotamab deruxtecan (Dato-DXd) to the standard pill osimertinib can better control advanced EGFR-mutated non-small cell lung cancer compared to osimertinib alone. About 582 adults with stage IIIB/IV or recurrent disease will receive either the combination or monotherapy. The main goal is to see if the combo delays cancer growth or death.

What this could mean

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

Active substance
osimertinib (Tagrisso) and datopotamab deruxtecan (Dato-DXd)
What this could lead to
If successful, this combination could delay cancer progression and improve survival for people with EGFR-mutated lung cancer, offering a new first-line option.
What could go wrong
This is an early-phase 3 trial with a long duration (up to 8 years). The combination may cause more side effects than osimertinib alone, and it is not yet known if it will meaningfully extend life.

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

About 582 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

Aug 2031

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: Age 1. Participant must be ≥ 18 years. Type of Participant and Disease Characteristics 2. Histologically or cytologically documented nonsquamous NSCLC. NSCLC of mixed histology is allowed if adenocarcinoma is the predominant histology. Mixed small-cell lung cancer and NSCLC histology, and sarcomatoid variant of NSCLC is ineligible. 3. Stage IIIB or IIIC or Stage IV metastatic NSCLC or recurrent NSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative surgery or definitive chemoradiation at the time of randomisation. 4. Participants must not have received prior EGFR TKIs or other systemic therapy for Stage IIIB, IIIC or IV NSCLC. 5. The tumour harbors at least 1 of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del or L858R), either alone or in combination with other genomic alterations, which may include EGFR T790M, assessed by a CLIA-certified (US sites) or an accredited (outside of the US) local laboratory or by central prospective tissue testing. 6. For participants enrolled in randomisation period, mandatory provision of an unstained, archival tumour tissue sample in a quantity sufficient to allow for central confirmation of the EGFR mutation status. 7. WHO performance status of 0 or 1. 8. At least one lesion not previously irradiated that qualifies as a RECIST 1.1 TL at baseline and can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes, which must have short axis ≥15 mm) with CT or MRI and is suitable for accurate repeated measurements. 9. Adequate bone marrow reserve and organ function before the first dose of study intervention. Exclusion Criteria: 1. As judged by the investigator, any evidence of diseases (such as severe or uncontrolled systemic diseases, including active bleeding diseases, history of allogenic organ transplant which, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardise compliance with the protocol. 2. Refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption, distribution, metabolism, or excretion of osimertinib. 3. History of another primary malignancy. 4. Spinal cord compression and/or unstable brain metastases. 5. Clinically significant corneal disease. 6. Has active or uncontrolled hepatitis B or C virus infection, as defined by Protocol. 7. Past medical history of ILD/penumonitis, including radiation pneumonitis (apart from radiation pneumonitis that did not require steroids), or drug-induced ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening. 8. Has clinically severe pulmonary function compromise resulting from intercurrent pulmonary illnesses.

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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.

Non-small cell lung cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    134 sites in 16 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Research Site

    SUSPENDED

    Fountain Valley, California, 92708, United States

  • Research Site

    RECRUITING

    Los Alamitos, California, 90720, United States

  • Research Site

    RECRUITING

    Los Angeles, California, 90017, United States

  • Research Site

    RECRUITING

    Los Angeles, California, 90033, United States

  • Research Site

    RECRUITING

    Orange, California, 92868, United States

  • Research Site

    RECRUITING

    San Diego, California, 92123, United States

  • Research Site

    RECRUITING

    Santa Monica, California, 90404, United States

  • Research Site

    RECRUITING

    Walnut Creek, California, 94598, United States

  • Research Site

    RECRUITING

    New Haven, Connecticut, 06510, United States

  • Research Site

    WITHDRAWN

    Washington D.C., District of Columbia, 20037, United States

  • Research Site

    RECRUITING

    Jacksonville, Florida, 32256, United States

  • Research Site

    RECRUITING

    Ocala, Florida, 34474, United States

  • Research Site

    RECRUITING

    Orange City, Florida, 32763, United States

  • Research Site

    WITHDRAWN

    Honolulu, Hawaii, 96819, United States

  • Research Site

    WITHDRAWN

    Chicago, Illinois, 60611, United States

  • Research Site

    RECRUITING

    Hinsdale, Illinois, 60521, United States

  • Research Site

    RECRUITING

    North Chicago, Illinois, 60064, United States

  • Research Site

    RECRUITING

    Fort Wayne, Indiana, 46845, United States

  • Research Site

    RECRUITING

    Bethesda, Maryland, 20817, United States

  • Research Site

    RECRUITING

    Detroit, Michigan, 48201, United States

  • Research Site

    RECRUITING

    Saint Paul, Minnesota, 55102, United States

  • Research Site

    WITHDRAWN

    Bridgeton, Missouri, 63044, United States

  • Research Site

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Research Site

    RECRUITING

    Las Vegas, Nevada, 89169, United States

  • Research Site

    RECRUITING

    Brooklyn, New York, 11212, United States

  • Research Site

    RECRUITING

    New York, New York, 10065, United States

  • Research Site

    WITHDRAWN

    Dallas, Texas, 75390, United States

  • Research Site

    RECRUITING

    Houston, Texas, 77030, United States

  • Research Site

    WITHDRAWN

    Houston, Texas, 77090, United States

  • Research Site

    RECRUITING

    Webster, Texas, 77598, United States

  • Research Site

    RECRUITING

    Woodway, Texas, 76712, United States

  • Research Site

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Research Site

    RECRUITING

    Fort Belvoir, Virginia, 22060, United States

  • Research Site

    RECRUITING

    Midlothian, Virginia, 23114, United States

  • Research Site

    WITHDRAWN

    Seattle, Washington, 98104, United States

  • Research Site

    RECRUITING

    Tacoma, Washington, 98405, United States

  • Research Site

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Research Site

    RECRUITING

    Camperdown, 2050, Australia

  • Research Site

    RECRUITING

    Clayton, 3168, Australia

  • Research Site

    RECRUITING

    Kogarah, 2217, Australia

  • Research Site

    RECRUITING

    South Brisbane, 4101, Australia

  • Research Site

    RECRUITING

    Westmead, 2145, Australia

  • Research Site

    RECRUITING

    Barretos, 14784-400, Brazil

  • Research Site

    RECRUITING

    Natal, 59075-740, Brazil

  • Research Site

    RECRUITING

    Porto Alegre, 91350-200, Brazil

  • Research Site

    RECRUITING

    Salvador, 41253-190, Brazil

  • Research Site

    RECRUITING

    São Paulo, 01246-000, Brazil

  • Research Site

    RECRUITING

    Edmonton, Alberta, T6G 1Z2, Canada

  • Research Site

    RECRUITING

    Montreal, Quebec, H4A 3J1, Canada

  • Research Site

    RECRUITING

    Beijing, 100029, China

  • Research Site

    RECRUITING

    Beijing, 100034, China

  • Research Site

    RECRUITING

    Beijing, 100142, China

  • Research Site

    RECRUITING

    Changchun, 130000, China

  • Research Site

    RECRUITING

    Changsha, 410013, China

  • Research Site

    RECRUITING

    Chengdu, 610000, China

  • Research Site

    RECRUITING

    Chengdu, 610042, China

  • Research Site

    RECRUITING

    Chengdu, 610072, China

  • Research Site

    RECRUITING

    Chongqing, 400030, China

  • Research Site

    RECRUITING

    Chongqing, 402260, China

  • Research Site

    RECRUITING

    Guangzhou, 510100, China

  • Research Site

    RECRUITING

    Hangzhou, 310006, China

  • Research Site

    RECRUITING

    Hangzhou, 31000, China

  • Research Site

    RECRUITING

    Hangzhou, 310022, China

  • Research Site

    RECRUITING

    Harbin, 150049, China

  • Research Site

    RECRUITING

    Hefei, 230031, China

  • Research Site

    RECRUITING

    Hefei, 230601, China

  • Research Site

    RECRUITING

    Jinan, 250021, China

  • Research Site

    RECRUITING

    Jinan, 250117, China

  • Research Site

    RECRUITING

    Kunming, 650118, China

  • Research Site

    RECRUITING

    Linhai, 317000, China

  • Research Site

    RECRUITING

    Ningbo, 315010, China

  • Research Site

    RECRUITING

    Shanghai, 200030, China

  • Research Site

    RECRUITING

    Shanghai, 200433, China

  • Research Site

    RECRUITING

    Shenyang, 110004, China

  • Research Site

    RECRUITING

    Wenzhou, 325000, China

  • Research Site

    RECRUITING

    Wuhan, 430022, China

  • Research Site

    RECRUITING

    Wuhan, 430030, China

  • Research Site

    RECRUITING

    Xi'an, 710061, China

  • Research Site

    RECRUITING

    Xuzhou, 221000, China

  • Research Site

    RECRUITING

    Yangzhou, 225001, China

  • Research Site

    RECRUITING

    Zhengzhou, 450000, China

  • Research Site

    RECRUITING

    Zhengzhou, 450008, China

  • Research Site

    RECRUITING

    Angers, 49055, France

  • Research Site

    RECRUITING

    Marseille, 13915, France

  • Research Site

    RECRUITING

    Paris, 75005, France

  • Research Site

    RECRUITING

    Strasbourg, 67091, Cedex, France

  • Research Site

    RECRUITING

    Berlin, 13125, Germany

  • Research Site

    RECRUITING

    Cologne, 51109, Germany

  • Research Site

    RECRUITING

    Erfurt, 99089, Germany

  • Research Site

    RECRUITING

    Frankfurt, 60488, Germany

  • Research Site

    WITHDRAWN

    Göttingen, 37075, Germany

  • Research Site

    RECRUITING

    Immenhausen, 34376, Germany

  • Research Site

    RECRUITING

    Kiel, 24105, Germany

  • Research Site

    RECRUITING

    Mainz, 55131, Germany

  • Research Site

    RECRUITING

    München, 81925, Germany

  • Research Site

    RECRUITING

    Hong Kong, 999077, Hong Kong

  • Research Site

    RECRUITING

    Hong Kong, Hong Kong

  • Research Site

    RECRUITING

    Jordan, 999077, Hong Kong

  • Research Site

    RECRUITING

    Lai Chi Kok, Hong Kong

  • Research Site

    RECRUITING

    Bangalore, 560027, India

  • Research Site

    WITHDRAWN

    Delhi, 110085, India

  • Research Site

    RECRUITING

    Hyderabad, 500032, India

  • Research Site

    WITHDRAWN

    Kolkata, 700054, India

  • Research Site

    WITHDRAWN

    Mysuru, 570017, India

  • Research Site

    WITHDRAWN

    Nagpur, 440001, India

  • Research Site

    RECRUITING

    Nashik, 422011, India

  • Research Site

    WITHDRAWN

    New Delhi, 100049, India

  • Research Site

    RECRUITING

    New Delhi, 11029, India

  • Research Site

    RECRUITING

    Vadodara, 391760, India

  • Research Site

    WITHDRAWN

    Varanasi, 221005, India

  • Research Site

    RECRUITING

    Milan, 20141, Italy

  • Research Site

    RECRUITING

    Monza, 20900, Italy

  • Research Site

    RECRUITING

    Orbassano, 10043, Italy

  • Research Site

    RECRUITING

    Padova, 35128, Italy

  • Research Site

    RECRUITING

    Parma, 43100, Italy

  • Research Site

    RECRUITING

    Chūōku, 104-0045, Japan

  • Research Site

    RECRUITING

    Fukuoka, 812-8582, Japan

  • Research Site

    RECRUITING

    Kashiwa, 277-8577, Japan

  • Research Site

    RECRUITING

    Kōtoku, 135-8550, Japan

  • Research Site

    RECRUITING

    Niigata, 951-8566, Japan

  • Research Site

    RECRUITING

    Osaka, 541-8567, Japan

  • Research Site

    RECRUITING

    Sakai, 590-0197, Japan

  • Research Site

    RECRUITING

    Sapporo, 003-0804, Japan

  • Research Site

    RECRUITING

    Sendai, 981-0914, Japan

  • Research Site

    RECRUITING

    Wakayama, 641-8510, Japan

  • Research Site

    RECRUITING

    Yokohama, 241-8515, Japan

  • Research Site

    RECRUITING

    Bystra, 43-360, Poland

  • Research Site

    RECRUITING

    Olsztyn, 10-357, Poland

  • Research Site

    RECRUITING

    Poznan, 60-569, Poland

  • Research Site

    RECRUITING

    Warsaw, 02-781, Poland

  • Research Site

    RECRUITING

    Rio Piedras, 00935, Puerto Rico

  • Research Site

    RECRUITING

    San Juan, 00918, Puerto Rico

  • Research Site

    ACTIVE_NOT_RECRUITING

    Goyang-si, 410-769, South Korea

  • Research Site

    ACTIVE_NOT_RECRUITING

    Namdong-gu, 21565, South Korea

  • Research Site

    ACTIVE_NOT_RECRUITING

    Seoul, 03080, South Korea

  • Research Site

    ACTIVE_NOT_RECRUITING

    Seoul, 06351, South Korea

  • Research Site

    ACTIVE_NOT_RECRUITING

    Seoul, 120-752, South Korea

  • Research Site

    ACTIVE_NOT_RECRUITING

    Suwon, 16247, South Korea

  • Research Site

    RECRUITING

    A Coruña, 15006, Spain

  • Research Site

    RECRUITING

    Barcelona, 8036, Spain

  • Research Site

    RECRUITING

    Granada, 18007, Spain

  • Research Site

    RECRUITING

    Madrid, 28040, Spain

  • Research Site

    RECRUITING

    Majadahonda, 28222, Spain

  • Research Site

    RECRUITING

    Valencia, 46009, Spain

  • Research Site

    RECRUITING

    Taichung, 40705, Taiwan

  • Research Site

    RECRUITING

    Tainan, 704, Taiwan

  • Research Site

    RECRUITING

    Taipei, 10002, Taiwan

  • Research Site

    RECRUITING

    Taipei, 106, Taiwan

  • Research Site

    RECRUITING

    Taipei, TAIWAN, Taiwan

  • Research Site

    RECRUITING

    Taoyuan, 333, Taiwan

  • Research Site

    ACTIVE_NOT_RECRUITING

    Bangkok, 10400, Thailand

  • Research Site

    ACTIVE_NOT_RECRUITING

    Bangkok, 10700, Thailand

  • Research Site

    ACTIVE_NOT_RECRUITING

    Dusit, 10300, Thailand

  • Research Site

    ACTIVE_NOT_RECRUITING

    Hat Yai, 90110, Thailand

  • Research Site

    ACTIVE_NOT_RECRUITING

    Udon Thani, 41000, Thailand

  • Research Site

    RECRUITING

    Adapazarı, 54100, Turkey (Türkiye)

  • Research Site

    RECRUITING

    Ankara, 06530, Turkey (Türkiye)

  • Research Site

    WITHDRAWN

    Goztepe Istanbul, Turkey (Türkiye)

  • Research Site

    WITHDRAWN

    Izmir, 35100, Turkey (Türkiye)

  • Research Site

    RECRUITING

    Küçükçekmece, 34295, Turkey (Türkiye)

  • Research Site

    RECRUITING

    Seyhan, 1060, Turkey (Türkiye)

  • Research Site

    ACTIVE_NOT_RECRUITING

    Hanoi, 100000, Vietnam

  • Research Site

    ACTIVE_NOT_RECRUITING

    Hà Nội, 100000, Vietnam

  • Research Site

    ACTIVE_NOT_RECRUITING

    Ho Chi Minh City, 700000, Vietnam

  • Research Site

    ACTIVE_NOT_RECRUITING

    Ho Chi Minh City, 70000, Vietnam

  • Research Site

    ACTIVE_NOT_RECRUITING

    Ho Chi Minh City, Vietnam

  • Research Site

    ACTIVE_NOT_RECRUITING

    Vinh, 460000, Vietnam

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