New hope for lung cancer patients: targeted drug Dato-DXd faces off against chemo

NCT ID NCT07291037

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Sep 04, 2026 · Updated 5 times

Summary

This phase 3 trial compares a new targeted drug, datopotamab deruxtecan (Dato-DXd), against the standard chemotherapy docetaxel in 400 people with advanced or metastatic non-squamous non-small cell lung cancer that lacks certain gene mutations. The goal is to see if Dato-DXd can slow cancer growth and improve survival. Participants must have TROP2-positive tumors and have received prior treatment.

What this could mean

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

Active substance: datopotamab deruxtecan (Dato-DXd)
What this could lead to: If it works, this could offer a more effective treatment option for people with advanced lung cancer who have limited choices.
What could go wrong: This is an early-stage comparison; the new drug may not prove better than the standard chemo and could have unexpected side effects.

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 400 people

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

Started

Oct 2025

Expected to finish

Jan 2029

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: \- Pathologically documented Stage IIIB, IIIC, or Stage IV non-squamous non-small cell lung cancer (NSCLC) without actionable genomic alterations (AGA) at the time of randomisation and meets the criteria for NSCLC: * Participants must have documented negative test results for EGFR (eg, exon 19 deletion or exon 21 L858R, exon 21 L861Q, exon 18 G719X, or exon 20 S768I mutation), ALK, and ROS1 genomic alterations. Note: If test results for EGFR, ALK, and ROS1 are not available, participants are required to undergo prospective testing performed centrally for these genomic alterations in a Sponsor-designated central laboratory. * Has no known tumour genomic alterations in NTRK, BRAF V600, RET, MET exon 14 skipping, KRAS G12C, or HER2. Additionally, participants must not have known tumour genomic alteration of any other actionable driver oncogenes for which there are locally approved targeted first-line therapies. Note: Participants whose tumours harbour BRAF (exception V600) or KRAS (exception G12C) mutations are eligible for the study. * Prospectively assessed TROP2 NMR positive based on results from an appropriately validated investigational TROP2 RxDx device in a Sponsor- designated, regulatory compliant central laboratory. * Documentation of radiographic disease progression while on or after receiving the most recent treatment regimen for advanced or metastatic NSCLC. * Participants must have received platinum based chemotherapy (PBC) in combination with anti-programmed death-protein 1 (anti-PD-1)/anti-programmed death-ligand 1 (anti-PD-L1) monoclonal antibody (mAb) as the only prior line of therapy or received PBC and anti-PD-1/anti-PD-L1 monoclonal antibody (in either order) sequentially as the only 2 prior lines of therapy. * Provision of acceptable formalin fixed and paraffin embedded (FFPE) tumour sample for assessment of TROP2. * At least one lesion not previously irradiated that qualifies as a Response Evaluation Criteria in Solid Tumours, Version 1.1 (RECIST 1.1) target lesion (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 computed tomography (CT) or magnetic resonance imaging (MRI) and is suitable for accurate repeated measurements. * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1. * Adequate bone marrow reserve and organ function within 7 days before randomisation. Exclusion Criteria: * Squamous, mixed NSCLC, or small cell lung cancer (SCLC) histology. * NSCLC disease that is eligible for definitive local therapy alone. * History of another primary malignancy other than NSCLC, except for malignancy treated with curative intent with no known active disease within 3 years before randomisation and of low potential risk for recurrence. * Spinal cord compression or brain metastases, unless asymptomatic, stable, and not requiring treatment with corticosteroids or anticonvulsants for at least 7 days prior to randomisation. * Clinically significant corneal disease. * Has active or uncontrolled hepatitis B or C virus infection. * Known human immunodeficiency virus (HIV) infection that is not well controlled. * Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals. * History of ILD/pneumonitis, 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. Examples of suspected ILD/pneumonitis by imaging include the presence of lung parenchymal fibrosis, such as combined pulmonary fibrosis and emphysema (CPFE), and any radiographic features consistent with interstitial lung abnormalities, including but not limited to, extensive ground glass opacities, reticular opacities, traction bronchiectasis, and honeycombing. * Has severe pulmonary function compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli within 3 months of the study enrolment, severe asthma, severe COPD, restrictive lung disease, symptomatic pleural effusion, etc).

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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 (NSCLC)

How to take part

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

The places running it

197 sites in 21 countries. The list below names each one and where it is.
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 ↗
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

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Chandler, Arizona, 85224, United States
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Gilbert, Arizona, 85234, United States
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Goodyear, Arizona, 85338, United States
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Duarte, California, 91010, United States
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Irvine, California, 92618, United States
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La Jolla, California, 92093, United States
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Loma Linda, California, 92350, United States
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Los Angeles, California, 90095, United States
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San Diego, California, 92123, United States
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Grand Junction, Colorado, 81501, United States
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Wheat Ridge, Colorado, 80033, United States
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Newark, Delaware, 19713, United States
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Washington D.C., District of Columbia, 20037, United States
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Fort Myers, Florida, 33901, United States
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Jacksonville, Florida, 32224, United States
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St. Petersburg, Florida, 33709, United States
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Tampa, Florida, 33612, United States
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West Palm Beach, Florida, 33401, United States
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Marietta, Georgia, 30060, United States
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Newnan, Georgia, 30265, United States
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Chicago, Illinois, 60612, United States
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Chicago, Illinois, 60637, United States
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Hinsdale, Illinois, 60521, United States
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Niles, Illinois, 60714, United States
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Zion, Illinois, 60099, United States
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Louisville, Kentucky, 40207, United States
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South Portland, Maine, 04106, United States
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Baltimore, Maryland, 21201, United States
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Brandywine, Maryland, 20613, United States
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Boston, Massachusetts, 02215, United States
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Detroit, Michigan, 48202, United States
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Rochester, Minnesota, 55905, United States
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Bridgeton, Missouri, 63044, United States
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Columbia, Missouri, 65212, United States
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Lincoln, Nebraska, 68516, United States
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Albuquerque, New Mexico, 87109, United States
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East Syracuse, New York, 13057, United States
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Portland, Oregon, 97239, United States
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Hershey, Pennsylvania, 17033, United States
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Lancaster, Pennsylvania, 17601, United States
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Greenville, South Carolina, 29607, United States
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Memphis, Tennessee, 38120, United States
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Austin, Texas, 78745, United States
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Denton, Texas, 76201, United States
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Plano, Texas, 75075, United States
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Charlottesville, Virginia, 22908, United States
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Fairfax, Virginia, 22031, United States
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Williamsburg, Virginia, 23188, United States
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Tacoma, Washington, 98405, United States
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Morgantown, West Virginia, 26506, United States
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Eau Claire, Wisconsin, 54703, United States
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Gosford, 2250, Australia
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Kogarah, 2217, Australia
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South Brisbane, 4101, Australia
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St Albans, 3021, Australia
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Wollongong, 2500, Australia
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Graz, 8036, Austria
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Linz, 4021, Austria
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Rankweil, 6830, Austria
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Vienna, 1140, Austria
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Vienna, 1210, Austria
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Hasselt, 3500, Belgium
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La Louvière, 7100, Belgium
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Libramont-Chevigny, 6800, Belgium
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Sint-Niklaas, 9100, Belgium
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Yvoir, 5530, Belgium
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Porto Alegre, 90610-000, Brazil
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Porto Alegre, 91350-200, Brazil
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Salvador, 40170-110, Brazil
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São Paulo, 01246-000, Brazil
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São Paulo, 01327-001, Brazil
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São Paulo, 05652-900, Brazil
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Vancouver, British Columbia, VSZ 4E6, Canada
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Moncton, New Brunswick, E1C 6Z8, Canada
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Halifax, Nova Scotia, B3H 2Y9, Canada
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Brampton, Ontario, L6R 3J7, Canada
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Hamilton, Ontario, L8V 1C3, Canada
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Toronto, Ontario, M5G 1X6, Canada
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Beijing, 100034, China
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Beijing, 100142, China
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Beijing, 101149, China
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Changchun, 130000, China
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Changsha, 410013, China
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Chengdu, 610041, China
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Chengdu, 610072, China
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Chongqing, 400030, China
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Fuzhou, 350011, China
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Guangzhou, 510080, China
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Hangzhou, 310022, China
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Harbin, 150081, China
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Hefei, 230610, China
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Jiamusi, 154007, China
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Jinan, 250117, China
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Nanchang, 330006, China
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Nanjing, 2100008, China
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Shanghai, 200030, China
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Shanghai, 200032, China
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Shanghai, 200433, China
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Shantou, 515041, China
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Shenyang, 110004, China
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Tianjin, 300050, China
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Wuhan, 430030, China
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Wuhan, 430060, China
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Xuzhou, 221009, China
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Zhengzhou, 450008, China
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Zhengzhou, 450052, China
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Boulogne-Billancourt, 92104, France
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Lyon, 69008, France
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Marseille, 13915, France
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Saint-Herblain, 44800, France
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Toulouse, 31400, France
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Bad Saarow, 15526, Germany
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Bielefeld, 33611, Germany
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Bonn, 53127, Germany
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Cologne, 51109, Germany
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Essen, 45147, Germany
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Frankfurt, 60488, Germany
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Freiburg im Breisgau, 79106, Germany
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Gauting, 82131, Germany
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Hamburg, 20251, Germany
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Heidelberg, 69126, Germany
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Krefeld, 47805, Germany
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Minden, 32429, Germany
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Oldenburg, 26121, Germany
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Stuttgart, 70174, Germany
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Troisdorf, 53840, Germany
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Velbert, 42551, Germany
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Budapest, 1083, Hungary
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Budapest, 1121, Hungary
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Budapest, 1122, Hungary
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Budapest, 1145, Hungary
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Debrecen, 4032, Hungary
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Gyöngyös - Mátraháza, 3200, Hungary
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Győr, 9024, Hungary
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Gyula, 5700, Hungary
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Kecskemét, 6000, Hungary
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Szolnok, 5000, Hungary
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Törökbálint, 2045, Hungary
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Bangalore, 560027, India
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Kolkata, 700016, India
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Mumbai, 400012, India
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Nashik, 422011, India
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New Delhi, 11029, India
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Milan, 20141, Italy
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Milan, 20162, Italy
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Monza, 20052, Italy
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Orbassano, 10043, Italy
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Padova, 35128, Italy
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Rozzano, 20089, Italy
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Chūōku, 104-0045, Japan
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Fukuoka, 812-8582, Japan
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Hiroshima, 734-8551, Japan
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Iwakuni-shi, 740-8510, Japan
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Kashiwa, 277-8577, Japan
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Kawasaki-shi, 216-8511, Japan
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Kyoto, 612-8555, Japan
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Matsuyama, 791-0280, Japan
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Nagoya, 464-8681, Japan
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Niigata, 951-8566, Japan
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Osaka, 541-8567, Japan
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Osakasayama-shi, 589-8511, Japan
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Sendai, 981-0914, Japan
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Sunto-gun, 411-8777, Japan
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Yokohama, 241-8515, Japan
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Lodz, 93-338, Poland
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Olsztyn, 10-357, Poland
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Poznan, 60-569, Poland
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Warsaw, 02-781, Poland
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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, 06351, South Korea
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Seoul, 5505, South Korea
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Suwon, 16247, South Korea
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A Coruña, 15009, Spain
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Barcelona, 8035, Spain
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L'Hospitalet de Llobregat, 08908, Spain
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Madrid, 28041, Spain
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Málaga, 29010, Spain
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Seville, 41009, Spain
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Zaragoza, 50009, Spain
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Kaohsiung City, 80756, Taiwan
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Taichung, 40705, Taiwan
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Tainan, 73657, Taiwan
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Taipei, 10002, Taiwan
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Taipei, 11217, Taiwan
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Taipei, 11490, Taiwan
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Taoyuan, 333, Taiwan
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Bangkok, 10210, Thailand
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Bangkok, 10300, Thailand
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Bangkok, 10700, Thailand
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Hat Yai, 90110, Thailand
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Muang, 50200, Thailand
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Ankara, 06530, Turkey (Türkiye)
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Istanbul, 32098, Turkey (Türkiye)
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Huddersfield, HD3 3EA, United Kingdom
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London, SE1 9RT, United Kingdom
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London, SW10 9NH, United Kingdom
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London, SW170QT, United Kingdom
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Maidstone, ME16 9QQ, United Kingdom
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Norwich, NR4 7UY, United Kingdom
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Stoke-on-Trent, ST4 6QG, United Kingdom
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Hanoi, 100000, Vietnam
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Ho Chi Minh City, 70 449, Vietnam
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Ho Chi Minh City, 700000, Vietnam
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Vinh, 460000, Vietnam

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