New hope for lung cancer: drug duo takes on standard therapy

NCT ID NCT06357533

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 13, 2026 · Updated 4 times

Summary

This Phase 3 trial is testing whether a combination of two drugs, datopotamab deruxtecan (Dato-DXd) and rilvegostomig, works better than the current standard treatment pembrolizumab for people with advanced non-squamous lung cancer that has high PD-L1 levels. About 675 participants will be randomly assigned to one of three groups. The study aims to see if the new combination can delay cancer growth and improve survival.

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) and rilvegostomig
What this could lead to: If successful, this could offer a new first-line treatment option for people with advanced non-squamous lung cancer that has high PD-L1 levels, potentially improving how long they live without their cancer growing.
What could go wrong: This is a large Phase 3 trial, but it is still experimental. The new drug combination may not work better than the current standard treatment, and it could have unexpected side effects. Results may not apply to all lung cancer patients.

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 675 people

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

Started

Apr 2024

Expected to finish

Dec 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: * Histologically or cytologically documented non-squamous NSCLC. * Stage IIIB or IIIC or Stage IV metastatic NSCLC (according to Edition 8 of the AJCC staging manual) not amenable to curative surgery or definitive chemoradiation. * Absence of sensitising EGFR mutations, and ALK and ROS1 rearrangements, and absence of documented local test result for any other known genomic alteration for which there are locally approved and available targeted first-line therapies. * Must provide tumor sample to determine PD-L1 status, TROP2 status and other biomarkers. * Known tumour PD-L1 expression status defined as TC ≥ 50% * At least one lesion, not previously irradiated that qualifies as a RECIST 1.1 target lesion at baseline * ECOG performance status of 0 or 1 * Adequate bone marrow reserve and organ function Exclusion Criteria: * Prior systemic therapy for advanced/metastatic NSCLC. * Squamous cell histology, or predominantly squamous cell histology NSCLC; mixed small cell lung cancer; NSCLC histology, sarcomatoid variant. * History of another primary malignancy within 3 years * Active or prior documented autoimmune or inflammatory disorders (with exceptions) * Any evidence of severe or uncontrolled disease that makes it undesirable for the participant to participate in the study or that would jeopardies compliance with the protocol. * Has clinically significant third-space fluid retention (for example pleural effusion) and is not amenable for repeated drainage. * History of any ILD/pneumonitis, including radiation pneumonitis (apart from radiation pneumonitis that did not require steroids), or drug-induced ILD/pneumonitis, has current or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening. * Has significant pulmonary function compromise, as determined by the investigator * Spinal cord compression, or brain metastases unless participant treated and no longer symptomatic, radiologically stable, and who require no treatment with corticosteroids or anticonvulsants. * History of leptomeningeal carcinomatosis * Known clinically significant corneal disease * Active infection with TB, HBV, HCV, Hepatitis A, or known HIV infection that is not well controlled * History of active primary immunodeficiency

Get updates

Get notified about this study

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

The places running it

255 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

Research Site
RECRUITING

Anchorage, Alaska, 99508, United States
Research Site
RECRUITING

Tucson, Arizona, 85719, United States
Research Site
RECRUITING

Little Rock, Arkansas, 72205, United States
Research Site
RECRUITING

Springdale, Arkansas, 72762, United States
Research Site
RECRUITING

Anaheim, California, 92801, United States
Research Site
RECRUITING

Beverly Hills, California, 90211, United States
Research Site
RECRUITING

Fountain Valley, California, 92708, United States
Research Site
SUSPENDED

Newport Beach, California, 92663, United States
Research Site
RECRUITING

Clermont, Florida, 34711, United States
Research Site
RECRUITING

Gainesville, Florida, 32608, United States
Research Site
RECRUITING

Miami Beach, Florida, 33140, United States
Research Site
RECRUITING

Orange City, Florida, 32763, United States
Research Site
RECRUITING

Orlando, Florida, 32806, United States
Research Site
WITHDRAWN

Orlando, Florida, 32827, United States
Research Site
RECRUITING

West Palm Beach, Florida, 33401, United States
Research Site
SUSPENDED

Atlanta, Georgia, 30303, United States
Research Site
RECRUITING

Atlanta, Georgia, 30318, United States
Research Site
RECRUITING

Atlanta, Georgia, 30322, United States
Research Site
WITHDRAWN

Atlanta, Georgia, 30342, United States
Research Site
RECRUITING

Hinsdale, Illinois, 60521, United States
Research Site
RECRUITING

Noblesville, Indiana, 46062, United States
Research Site
RECRUITING

Paducah, Kentucky, 42003, United States
Research Site
RECRUITING

Annapolis, Maryland, 21401, United States
Research Site
RECRUITING

Boston, Massachusetts, 02114, United States
Research Site
RECRUITING

Boston, Massachusetts, 02215, United States
Research Site
RECRUITING

Dearborn, Michigan, 48126, United States
Research Site
RECRUITING

Farmington Hills, Michigan, 48334, United States
Research Site
RECRUITING

Grand Rapids, Michigan, 49503, United States
Research Site
WITHDRAWN

Traverse City, Michigan, 49684, United States
Research Site
RECRUITING

Hattiesburg, Mississippi, 39401, United States
Research Site
RECRUITING

Kansas City, Missouri, 64132, United States
Research Site
WITHDRAWN

Bozeman, Montana, 59715, United States
Research Site
RECRUITING

Grand Island, Nebraska, 68803, United States
Research Site
RECRUITING

Omaha, Nebraska, 68130, United States
Research Site
RECRUITING

Las Vegas, Nevada, 89102, United States
Research Site
WITHDRAWN

Reno, Nevada, 89502, United States
Research Site
SUSPENDED

Voorhees Township, New Jersey, 08043, United States
Research Site
RECRUITING

Stony Brook, New York, 11794, United States
Research Site
RECRUITING

Greenville, North Carolina, 27834, United States
Research Site
RECRUITING

Salisbury, North Carolina, 28144, United States
Research Site
RECRUITING

Cincinnati, Ohio, 45219, United States
Research Site
WITHDRAWN

Columbus, Ohio, 43210, United States
Research Site
RECRUITING

Maumee, Ohio, 43537, United States
Research Site
RECRUITING

Toledo, Ohio, 43623, United States
Research Site
WITHDRAWN

Portland, Oregon, 97213, United States
Research Site
RECRUITING

Greenville, South Carolina, 29607, United States
Research Site
RECRUITING

Sioux Falls, South Dakota, 57105, United States
Research Site
WITHDRAWN

Chattanooga, Tennessee, 37404, United States
Research Site
WITHDRAWN

Knoxville, Tennessee, 37920, United States
Research Site
RECRUITING

Fort Worth, Texas, 76104, United States
Research Site
RECRUITING

Houston, Texas, 77030, United States
Research Site
WITHDRAWN

Houston, Texas, 77030, United States
Research Site
SUSPENDED

Houston, Texas, 77090, United States
Research Site
RECRUITING

Kingwood, Texas, 77339, United States
Research Site
RECRUITING

Odessa, Texas, 79761, United States
Research Site
RECRUITING

Fort Belvoir, Virginia, 22060, United States
Research Site
RECRUITING

Leesburg, Virginia, 20176, United States
Research Site
RECRUITING

Midlothian, Virginia, 23114, United States
Research Site
RECRUITING

Richmond, Virginia, 23230, United States
Research Site
RECRUITING

Tacoma, Washington, 98405, United States
Research Site
RECRUITING

Vancouver, Washington, 98684, United States
Research Site
RECRUITING

Wenatchee, Washington, 98801, United States
Research Site
RECRUITING

Appleton, Wisconsin, 54911, United States
Research Site
RECRUITING

Birtinya, 4575, Australia
Research Site
WITHDRAWN

Blacktown, 2148, Australia
Research Site
RECRUITING

Clayton, 3168, Australia
Research Site
RECRUITING

Gosford, 2250, Australia
Research Site
WITHDRAWN

Melbourne, 3000, Australia
Research Site
RECRUITING

South Brisbane, QL 4101, Australia
Research Site
RECRUITING

Wodonga, 3690, Australia
Research Site
RECRUITING

Innsbruck, 6020, Austria
Research Site
RECRUITING

Krems, 3500, Austria
Research Site
RECRUITING

Linz, 4020, Austria
Research Site
RECRUITING

Rankweil, 6830, Austria
Research Site
RECRUITING

Vienna, 1140, Austria
Research Site
RECRUITING

Vienna, 1210, Austria
Research Site
RECRUITING

Wels, 4600, Austria
Research Site
WITHDRAWN

Anderlecht, 1070, Belgium
Research Site
RECRUITING

Bruges, 8000, Belgium
Research Site
RECRUITING

Hasselt, 3500, Belgium
Research Site
RECRUITING

La Louvière, 7100, Belgium
Research Site
RECRUITING

Liège, 4000, Belgium
Research Site
RECRUITING

Barretos, 14784-400, Brazil
Research Site
RECRUITING

Curitiba, 80730-150, Brazil
Research Site
RECRUITING

Florianópolis, 88034-000, Brazil
Research Site
RECRUITING

Ipatinga, 35162-189, Brazil
Research Site
RECRUITING

Natal, 59075-740, Brazil
Research Site
RECRUITING

Porto Alegre, 91350-200, Brazil
Research Site
RECRUITING

Rio de Janeiro, 22211-230, Brazil
Research Site
RECRUITING

Santa Maria, 97015-450, Brazil
Research Site
RECRUITING

São Paulo, 01221-020, Brazil
Research Site
RECRUITING

Taubaté, 12030-200, Brazil
Research Site
RECRUITING

Vancouver, British Columbia, VSZ 4E6, Canada
Research Site
WITHDRAWN

Winnipeg, Manitoba, R3E 0V9, Canada
Research Site
RECRUITING

St. John's, Newfoundland and Labrador, A1B 3V6, Canada
Research Site
RECRUITING

London, Ontario, N6A 4L6, Canada
Research Site
WITHDRAWN

Newmarket, Ontario, L3Y 2P9, Canada
Research Site
RECRUITING

Oshawa, Ontario, L1G 2B9, Canada
Research Site
WITHDRAWN

Toronto, Ontario, M4N 3M5, Canada
Research Site
RECRUITING

Lévis, Quebec, G6V 0B8, Canada
Research Site
RECRUITING

Montreal, Quebec, H3T 1E2, Canada
Research Site
RECRUITING

Montreal, Quebec, H3T 1M5, Canada
Research Site
RECRUITING

Montreal, Quebec, H4J 1C5, Canada
Research Site
RECRUITING

Rimouski, Quebec, G5L 5T1, Canada
Research Site
RECRUITING

Trois-Rivières, Quebec, G8Z 3R9, Canada
Research Site
RECRUITING

Saskatoon, Saskatchewan, S7N 4H4, Canada
Research Site
RECRUITING

Chicoutimi, G7H 5H6, Canada
Research Site
RECRUITING

Beijing, 100142, China
Research Site
RECRUITING

Beijing, 101149, China
Research Site
NOT_YET_RECRUITING

Changchun, 130000, China
Research Site
RECRUITING

Changsha, 410013, China
Research Site
RECRUITING

Chengdu, 610000, China
Research Site
RECRUITING

Chengdu, 610041, China
Research Site
RECRUITING

Chongqing, 400030, China
Research Site
RECRUITING

Fuzhou, 350014, China
Research Site
RECRUITING

Guangzhou, 510080, China
Research Site
RECRUITING

Hangzhou, 310006, China
Research Site
RECRUITING

Hangzhou, 310016, China
Research Site
RECRUITING

Hangzhou, 310022, China
Research Site
RECRUITING

Harbin, 150049, China
Research Site
WITHDRAWN

Hefei, 230031, China
Research Site
RECRUITING

Hefei, 230601, China
Research Site
RECRUITING

Jinan, 250117, China
Research Site
WITHDRAWN

Jining, 272011, China
Research Site
RECRUITING

Kunming, 650118, China
Research Site
RECRUITING

Lanzhou, 730000, China
Research Site
RECRUITING

Linhai, 317000, China
Research Site
RECRUITING

Linyi, 276001, China
Research Site
RECRUITING

Nanjing, 210009, China
Research Site
RECRUITING

Nanning, 530000, China
Research Site
RECRUITING

Nanning, 530021, China
Research Site
RECRUITING

Shanghai, 200030, China
Research Site
RECRUITING

Shanghai, 200032, China
Research Site
RECRUITING

Shanghai, 200433, China
Research Site
RECRUITING

Shenyang, 110022, China
Research Site
RECRUITING

Taiyuan, 030000, China
Research Site
RECRUITING

Tianjin, 300060, China
Research Site
RECRUITING

Wenzhou, 325000, China
Research Site
RECRUITING

Wuhan, 430000, China
Research Site
RECRUITING

Wuhan, 430010, China
Research Site
RECRUITING

Wuhan, 430022, China
Research Site
RECRUITING

Wuhan, 430030, China
Research Site
RECRUITING

Xi'an, 710061, China
Research Site
RECRUITING

Yangzhou, 225001, China
Research Site
RECRUITING

Zhengzhou, 450000, China
Research Site
RECRUITING

Zhengzhou, 450008, China
Research Site
NOT_YET_RECRUITING

Berlin, 10249, Germany
Research Site
RECRUITING

Bonn, 53113, Germany
Research Site
RECRUITING

Cologne, 50677, Germany
Research Site
WITHDRAWN

Düsseldorf, 40489, Germany
Research Site
RECRUITING

Essen, 45136, Germany
Research Site
RECRUITING

Freiburg im Breisgau, 79106, Germany
Research Site
RECRUITING

Gauting, 82131, Germany
Research Site
WITHDRAWN

Georgsmarienhütte, 49124, Germany
Research Site
WITHDRAWN

Gera, 07548, Germany
Research Site
WITHDRAWN

Gütersloh, 33332, Germany
Research Site
RECRUITING

Hamburg, 20251, Germany
Research Site
RECRUITING

Hamburg, 22087, Germany
Research Site
RECRUITING

Heidelberg, 69126, Germany
Research Site
RECRUITING

Kempten, 87439, Germany
Research Site
NOT_YET_RECRUITING

Kiel, 24116, Germany
Research Site
SUSPENDED

Koblenz, 56068, Germany
Research Site
WITHDRAWN

Ludwigsburg, 71640, Germany
Research Site
RECRUITING

München, 81925, Germany
Research Site
RECRUITING

Nuremberg, 90419, Germany
Research Site
RECRUITING

Potsdam, 14467, Germany
Research Site
RECRUITING

Ravensburg, 88212, Germany
Research Site
RECRUITING

Budapest, 1121, Hungary
Research Site
WITHDRAWN

Gyöngyös, 3200, Hungary
Research Site
RECRUITING

Gyöngyös - Mátraháza, 3200, Hungary
Research Site
RECRUITING

Győr, 9024, Hungary
Research Site
NOT_YET_RECRUITING

Gyula, 5700, Hungary
Research Site
RECRUITING

Kecskemét, 6000, Hungary
Research Site
WITHDRAWN

Salgótarján, 3100, Hungary
Research Site
RECRUITING

Szekszárd, 7100, Hungary
Research Site
RECRUITING

Székesfehérvár, 8000, Hungary
Research Site
NOT_YET_RECRUITING

Szolnok, 5000, Hungary
Research Site
RECRUITING

Törökbálint, 2045, Hungary
Research Site
RECRUITING

Chennai, 600031, India
Research Site
RECRUITING

Dwārka, 110075, India
Research Site
RECRUITING

Jaipur, 302004, India
Research Site
RECRUITING

Kolkata, 700099, India
Research Site
WITHDRAWN

Marg Jaipur, 302004, India
Research Site
RECRUITING

Nagpur, 440001, India
Research Site
RECRUITING

Nashik, 422011, India
Research Site
RECRUITING

New Delhi, 110085, India
Research Site
RECRUITING

New Delhi, 11029, India
Research Site
RECRUITING

Surat, 395002, India
Research Site
WITHDRAWN

Thiruvananthapuram, 695011, India
Research Site
RECRUITING

Bergamo, 24125, Italy
Research Site
RECRUITING

Genoa, 16132, Italy
Research Site
RECRUITING

Milan, 20141, Italy
Research Site
RECRUITING

Milan, 20162, Italy
Research Site
RECRUITING

Monza, 20052, Italy
Research Site
RECRUITING

Padova, 35128, Italy
Research Site
RECRUITING

Pavia, 27100, Italy
Research Site
RECRUITING

Ravenna, 48100, Italy
Research Site
RECRUITING

Roma, 00128, Italy
Research Site
RECRUITING

Rozzano, 20089, Italy
Research Site
RECRUITING

Bunkyō City, 113-8431, Japan
Research Site
RECRUITING

Bunkyō City, 160-0023, Japan
Research Site
RECRUITING

Fukuoka, 812-8582, Japan
Research Site
RECRUITING

Fukuoka, 814-0180, Japan
Research Site
RECRUITING

Hakodate-shi, 040-8611, Japan
Research Site
RECRUITING

Hidaka-shi, 350-1298, Japan
Research Site
RECRUITING

Hirakata-shi, 573-1191, Japan
Research Site
RECRUITING

Hirosaki-shi, 036-8563, Japan
Research Site
RECRUITING

Hiroshima, 730-8518, Japan
Research Site
RECRUITING

Kanazawa, 920-8641, Japan
Research Site
RECRUITING

Kashiwa, 227-8577, Japan
Research Site
RECRUITING

Kawasaki-shi, 216-8511, Japan
Research Site
RECRUITING

Kumamoto, 860-8556, Japan
Research Site
RECRUITING

Matsusaka-shi, 515-8544, Japan
Research Site
NOT_YET_RECRUITING

Matsuyama, 790-0024, Japan
Research Site
RECRUITING

Nagoya, 460-0001, Japan
Research Site
RECRUITING

Niigata, 951-8566, Japan
Research Site
RECRUITING

Okayama, 700-8558, Japan
Research Site
RECRUITING

Osaka, 545-8586, Japan
Research Site
RECRUITING

Osakasayama-shi, 589-8511, Japan
Research Site
RECRUITING

Sagamihara-shi, 252-0375, Japan
Research Site
RECRUITING

Sapporo, 003-0804, Japan
Research Site
RECRUITING

Takaoka-shi, 933-8555, Japan
Research Site
RECRUITING

Takatsuki-shi, 569-8686, Japan
Research Site
RECRUITING

Tokushima, 770-8503, Japan
Research Site
RECRUITING

Tokyo, 104-0045, Japan
Research Site
RECRUITING

Utsunomiya, 320-0834, Japan
Research Site
RECRUITING

Yokohama, 221-0855, Japan
Research Site
RECRUITING

Olsztyn, 10-357, Poland
Research Site
RECRUITING

Poznan, 60-569, Poland
Research Site
RECRUITING

Przemyśl, 37-700, Poland
Research Site
RECRUITING

Warsaw, 01-138, Poland
Research Site
RECRUITING

Warsaw, 02-781, Poland
Research Site
RECRUITING

San Juan, 00909, Puerto Rico
Research Site
RECRUITING

Changwon, 51353, South Korea
Research Site
RECRUITING

Incheon, 21565, South Korea
Research Site
RECRUITING

Seongnam-si, 13496, South Korea
Research Site
RECRUITING

Seoul, 03080, South Korea
Research Site
RECRUITING

Seoul, 03722, South Korea
Research Site
NOT_YET_RECRUITING

Seoul, 06973, South Korea
Research Site
RECRUITING

Suwon, 16247, South Korea
Research Site
RECRUITING

Suwon, 16499, South Korea
Research Site
RECRUITING

Alicante, 03010, Spain
Research Site
RECRUITING

Barcelona, 08003, Spain
Research Site
RECRUITING

Barcelona, 08036, Spain
Research Site
NOT_YET_RECRUITING

Barcelona, 08041, Spain
Research Site
RECRUITING

Jerez de la Frontera, 11407, Spain
Research Site
RECRUITING

Reus, 43204, Spain
Research Site
WITHDRAWN

Salamanca, 37007, Spain
Research Site
RECRUITING

Kaohsiung City, 80756, Taiwan
Research Site
RECRUITING

New Taipei City, 220, Taiwan
Research Site
RECRUITING

Taichung, 40447, Taiwan
Research Site
RECRUITING

Taichung, 40705, Taiwan
Research Site
RECRUITING

Tainan, 704, Taiwan
Research Site
RECRUITING

Taipei, 0116, Taiwan
Research Site
RECRUITING

Taipei, 10002, Taiwan
Research Site
RECRUITING

Taipei, 112, Taiwan
Research Site
RECRUITING

Taipei, TAIWAN, Taiwan
Research Site
RECRUITING

Taoyuan, 333, Taiwan
Research Site
RECRUITING

Bangkok, 10400, Thailand
Research Site
NOT_YET_RECRUITING

Bangkok, 10700, Thailand
Research Site
RECRUITING

Hat Yai, 90110, Thailand
Research Site
RECRUITING

Muang, 22000, Thailand
Research Site
RECRUITING

Mueang, 20000, Thailand
Research Site
RECRUITING

Mueang, 32000, Thailand
Research Site
RECRUITING

Adapazarı, 54100, Turkey (Türkiye)
Research Site
RECRUITING

Ankara, 06560, Turkey (Türkiye)
Research Site
RECRUITING

Ankara, 6200, Turkey (Türkiye)
Research Site
RECRUITING

Antalya, 07070, Turkey (Türkiye)
Research Site
RECRUITING

Diyarbakır, 21280, Turkey (Türkiye)
Research Site
RECRUITING

Istanbul, 34030, Turkey (Türkiye)
Research Site
RECRUITING

Istanbul, 34890, Turkey (Türkiye)
Research Site
SUSPENDED

Cheltenham, GL53 7AN, United Kingdom
Research Site
SUSPENDED

Inverness, IV2 3UJ, United Kingdom
Research Site
WITHDRAWN

London, SE1 9RT, United Kingdom
Research Site
RECRUITING

London, SW10 9NH, United Kingdom
Research Site
RECRUITING

London, SW17 0QT, United Kingdom
Research Site
NOT_YET_RECRUITING

Norwich, NR4 7UY, United Kingdom
Research Site
RECRUITING

Preston, PR2 9HT, United Kingdom
Research Site
RECRUITING

Truro, TR1 3LJ, United Kingdom
Research Site
RECRUITING

Da Nang, 550000, Vietnam
Research Site
RECRUITING

Hanoi, 100000, Vietnam
Research Site
RECRUITING

Hà Nội, 100000, Vietnam
Research Site
RECRUITING

Ho Chi Minh City, 700000, Vietnam
Research Site
WITHDRAWN

Ho Chi Minh City, 700000, Vietnam
Research Site
WITHDRAWN

Huế, 530000, Vietnam
Research Site
WITHDRAWN

Vinh, 460000, Vietnam
Research Site
RECRUITING

Vĩnh Yên, 280000, Vietnam

More trials for these conditions

Other studies related to the condition(s) this trial covers.