AzTrials
AzTrials

NSCLCPhase 3AVANZARNCT05687266

Phase III, Open-label, First-line Study of Dato-DXd in Combination With Durvalumab and Carboplatin for Advanced NSCLC Without Actionable Genomic Alterations

A Phase 3 study testing Datopotamab deruxtecan, Durvalumab and Carboplatin in people with NSCLC, run by AstraZeneca at 254 sites in 23 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This is a Phase III, randomized, open-label, multicenter, global study to compare the efficacy and safety of Datopotamab Deruxtecan (Dato-DXd) in combination with durvalumab and carboplatin compared with pembrolizumab in combination with histology-specific platinum-based chemotherapy as first-line treatment of adults… Read more about this study

Who is it for?
Ages 18 to 130 years
Conditions the study is for
NSCLC
What is being tested?
Datopotamab deruxtecan, Durvalumab and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,350 participants
Where
254 sitesin 23 countries
Study dates
29 Dec 2022to 1 Nov 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 130 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants ≥ 18 years at screening
  • Histologically or cytologically documented NSCLC that at the time of randomisation is Stage IIIB or IIIC disease not amenable to surgical resection or definitive chemoradiation or Stage IV metastatic disease
  • Lacks sensitising EGFR tumour tissue mutation and ALK and ROS1 rearrangements and has no documented tumour genomic alterations in NTRK, BRAF, RET, MET or other actionable driver oncogenes with approved and available therapies (actionable genomic alterations).
  • Testing is not required for tumors with squamous histology, with exceptions.
  • ECOG PS of 0 or 1
  • Archival tumour tissue
  • Has adequate bone marrow reserve and organ function within 7 days before randomization

Who cannot join

  • Mixed small-cell lung cancer and NSCLC histology; sarcomatoid variant of NSCLC
  • History of another primary malignancy with exceptions
  • Persistent toxicities caused by previous anti-cancer therapy not yet improved to Grade ≤ 1 or baseline, with exceptions.
  • Spinal cord compression or clinically or radiologically active brain metastases
  • History of leptomeningeal carcinomatosis.
  • Known active or uncontrolled hepatitis B or C virus infection.
Show all 9Show fewer
  • Uncontrolled or suspected infection requiring IV antibiotics, antivirals, or antifungals.
  • Clinically significant corneal disease
  • History of non-infectious ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.

Trial locations and contacts

254 sites in 23 countries.

254 sites in 23 countries

United States52 sites

  • Research Site

    Appleton, Wisconsin, 54911

  • Research Site

    Asheville, North Carolina, 28806

  • Research Site

    Baton Rouge, Louisiana, 70808

  • Research Site

    Bettendorf, Iowa, 52722

  • Research Site

    Boulder, Colorado, 80303

  • Research Site

    Canton, Ohio, 44710

  • Research Site

    Clifton Park, New York, 12065

  • Research Site

    Columbus, Ohio, 43219

  • Research Site

    Covington, Louisiana, 70433

  • Research Site

    Dallas, Texas, 75246

  • Research Site

    Duluth, Minnesota, 55805

  • Research Site

    Fairfax, Virginia, 22031

  • Research Site

    Fort Myers, Florida, 33901

  • Research Site

    Fort Wayne, Indiana, 46845

  • Research Site

    Fort Worth, Texas, 76104

  • Research Site

    Fountain Valley, California, 92708

  • Research Site

    Hannibal, Missouri, 63401

  • Research Site

    Henrico, Virginia, 23229

  • Research Site

    Hinsdale, Illinois, 60521

  • Research Site

    Hot Springs, Arkansas, 71913

  • Research Site

    Houston, Texas, 77030

  • Research Site

    Houston, Texas, 77090

  • Research Site

    Iowa City, Iowa, 52242

  • Research Site

    Irving, Texas, 75063

  • Research Site

    Jacksonville, Florida, 32224

  • Research Site

    La Crosse, Wisconsin, 54601

  • Research Site

    Lincoln, Nebraska, 68506

  • Research Site

    Lincoln, Nebraska, 68516

  • Research Site

    Little Rock, Arkansas, 72205

  • Research Site

    Los Angeles, California, 90017

  • Research Site

    Maumee, Ohio, 43537

  • Research Site

    Memphis, Tennessee, 38120

  • Research Site

    Norfolk, Virginia, 23502

  • Research Site

    Orange, California, 92868

  • Research Site

    Philadelphia, Pennsylvania, 19104

  • Research Site

    Philadelphia, Pennsylvania, 19107

  • Research Site

    Philadelphia, Pennsylvania, 19111

  • Research Site

    Phoenix, Arizona, 85054

  • Research Site

    Portland, Oregon, 97239

  • Research Site

    Renton, Washington, 98055

  • Research Site

    Rochester, Minnesota, 55905

  • Research Site

    Salem, Oregon, 97301

  • Research Site

    Spokane, Washington, 99202

  • Research Site

    Springdale, Arkansas, 72762

  • Research Site

    St. Petersburg, Florida, 33705

  • Research Site

    Tacoma, Washington, 98405

  • Research Site

    Tucson, Arizona, 85704

  • Research Site

    Tulsa, Oklahoma, 74134

  • Research Site

    Watertown, South Dakota, 57201

  • Research Site

    Waukee, Iowa, 50263

  • Research Site

    West Palm Beach, Florida, 33401

  • Research Site

    York, Pennsylvania, 17403

Other trials in United States

China33 sites

  • Research Site

    Beijing, 100010

  • Research Site

    Beijing, 100029

  • Research Site

    Beijing, 100037

  • Research Site

    Beijing, 100039

  • Research Site

    Beijing, 100853

  • Research Site

    Beijing, CN-100730

  • Research Site

    Changsha, 410008

  • Research Site

    Changsha, 410013

  • Research Site

    Chengdu, 610041

  • Research Site

    Chengdu, 610072

  • Research Site

    Chongqing, 400037

  • Research Site

    Guangzhou, 510000

  • Research Site

    Guangzhou, 510100

  • Research Site

    Hefei, 230601

  • Research Site

    Jinan, 250021

  • Research Site

    Kunming, 650101

  • Research Site

    Lanzhou, 730000

  • Research Site

    Liuzhou, 545006

  • Research Site

    Shandong

  • Research Site

    Shanghai, 200030

  • Research Site

    Shanghai, 200032

  • Research Site

    Shanghai, 200080

  • Research Site

    Shantou, 515041

  • Research Site

    Shenyang, 110004

  • Research Site

    Shenzhen, 517108

  • Research Site

    Taiyuan, 030000

  • Research Site

    Tianjin, 300060

  • Research Site

    Wenzhou, 325000

  • Research Site

    Wuhan, 430030

  • Research Site

    Wuhan, 430060

  • Research Site

    Xiamen, 361004

  • Research Site

    Yangzhou, 225131

  • Research Site

    Zhengzhou, 450052

Other trials in China

Japan18 sites

  • Research Site

    Bunkyō City, 113-8603

  • Research Site

    Chūōku, 104-0045

  • Research Site

    Hamamatsu, 431-3192

  • Research Site

    Hamamatsu, 432-8580

  • Research Site

    Hidaka-shi, 350-1298

  • Research Site

    Hirosaki-shi, 036-8563

  • Research Site

    Hiroshima, 730-8518

  • Research Site

    Kumamoto, 860-8556

  • Research Site

    Nagoya, 464-8681

  • Research Site

    Nagoya, 466-8560

  • Research Site

    Okayama, 700-8558

  • Research Site

    Osaka, 545-8586

  • Research Site

    Sakai, 590-0197

  • Research Site

    Sapporo, 060-8638

  • Research Site

    Sunto-gun, 411-8777

  • Research Site

    Wakayama, 641-8510

  • Research Site

    Yokohama, 221-0855

  • Research Site

    Yokohama, 241-8515

Other trials in Japan

France13 sites

  • Research Site

    Brest, 29200

  • Research Site

    Créteil, 94010

  • Research Site

    Gleizé, 69400

  • Research Site

    Montpellier, 34070

  • Research Site

    Nîmes, 30029

  • Research Site

    Paris, 75018

  • Research Site

    Paris, 75674

  • Research Site

    Rouen, 76031

  • Research Site

    Saint-Quentin, 02321

  • Research Site

    Strasbourg, 67091

  • Research Site

    Toulon, 83800

  • Research Site

    Toulouse, 31059

  • Research Site

    Tours, 37000

Other trials in France

Germany13 sites

  • Research Site

    Bad Berka, 99437

  • Research Site

    Berlin, 14109

  • Research Site

    Frankfurt A. Main, 60590

  • Research Site

    Gauting, 82131

  • Research Site

    Gütersloh, 33332

  • Research Site

    Hamburg, 20251

  • Research Site

    Kassel, 34125

  • Research Site

    Kiel, 24116

  • Research Site

    Koblenz, 56073

  • Research Site

    Minden, 32429

  • Research Site

    Rosenheim, 83022

  • Research Site

    Velbert, 42551

  • Research Site

    Würzburg, 97074

Other trials in Germany

Brazil11 sites

  • Research Site

    Blumenau, 89010-340

  • Research Site

    Florianópolis, 88034-000

  • Research Site

    Fortaleza, 60336-045

  • Research Site

    Londrina, 86015-520

  • Research Site

    Porto Alegre, 90035-903

  • Research Site

    São Paulo, 01246-000

  • Research Site

    São Paulo, 01327-001

  • Research Site

    São Paulo, 01509-900

  • Research Site

    São Paulo, 09323-900

  • Research Site

    Taubaté, 12030-200

  • Research Site

    Vitória, 29043-260

Other trials in Brazil

Poland11 sites

  • Research Site

    Bydgoszcz, 85-796

  • Research Site

    Bystra, 43-360

  • Research Site

    Grudziądz, 86-300

  • Research Site

    Kielce, 25-734

  • Research Site

    Koszalin, 75-581

  • Research Site

    Olsztyn, 10-357

  • Research Site

    Poznan, 60-569

  • Research Site

    Przemyśl, 37-700

  • Research Site

    Racibórz, 47-400

  • Research Site

    Radom, 26-600

  • Research Site

    Siedlce, 08-110

Other trials in Poland

United Kingdom11 sites

  • Research Site

    Aberdeen, AB25 2ZN

  • Research Site

    Cambridge, CB2 0QQ

  • Research Site

    Cardiff, CF14 2TL

  • Research Site

    Cheltenham, GL53 7AN

  • Research Site

    Edinburgh, EH4 2XU

  • Research Site

    London, SE1 9RT

  • Research Site

    London, W6 8RF

  • Research Site

    Manchester, M20 4BX

  • Research Site

    Middlesbrough, TS4 3BW

  • Research Site

    Newcastle upon Tyne, NE7 7DN

  • Research Site

    Taunton, TA1 5DA

Other trials in United Kingdom

Canada10 sites

  • Research Site

    Brampton, Ontario, L6R 3J7

  • Research Site

    Greater Sudbury, Ontario, P3E 5J1

  • Research Site

    Kitchener, Ontario, N2G 1G3

  • Research Site

    Montreal, Quebec, H1T 2M4

  • Research Site

    Montreal, Quebec, H4A 3J1

  • Research Site

    Montreal, Quebec, H4J 1C5

  • Research Site

    Newmarket, Ontario, L3Y 2P9

  • Research Site

    Saint John, New Brunswick, E2L 4L2

  • Research Site

    Saint-Jérôme, Quebec, J7Z 5T3

  • Research Site

    Saskatoon, Saskatchewan, S7N 4H4

Other trials in Canada

South Korea10 sites

  • Research Site

    Busan, 48108

  • Research Site

    Cheongju-si, 28644

  • Research Site

    Jinju, 52727

  • Research Site

    Seoul, 03080

  • Research Site

    Seoul, 03722

  • Research Site

    Seoul, 05505

  • Research Site

    Seoul, 06351

  • Research Site

    Seoul, 07061

  • Research Site

    Suwon, 16247

  • Research Site

    Suwon, 16499

Other trials in South Korea

Italy9 sites

  • Research Site

    Florence, 50134

  • Research Site

    Lecco, 23900

  • Research Site

    Messina, 98158

  • Research Site

    Naples, 80131

  • Research Site

    Orbassano, 10043

  • Research Site

    Padova, 35128

  • Research Site

    Parma, 43126

  • Research Site

    Peschiera del Garda, 37019

  • Research Site

    Rozzano, 20089

Other trials in Italy

Hungary8 sites

  • Research Site

    Budapest, 1121

  • Research Site

    Budapest, 1122

  • Research Site

    Gyöngyös - Mátraháza, 3200

  • Research Site

    Kaposvár, 7400

  • Research Site

    Pécs, 7624

  • Research Site

    Szekszárd, 7100

  • Research Site

    Szolnok, 5000

  • Research Site

    Törökbálint, 2045

Other trials in Hungary

India7 sites

  • Research Site

    Calicut, 673601

  • Research Site

    Delhi, 110029

  • Research Site

    Delhi, 110085

  • Research Site

    Jaipur, 302017

  • Research Site

    Kolkata, 700160

  • Research Site

    Madurai, 625107

  • Research Site

    Puducherry, 605006

Other trials in India

Spain7 sites

  • Research Site

    Las Palmas de Gran Canaria, 35016

  • Research Site

    Lugo, 27003

  • Research Site

    Madrid, 28041

  • Research Site

    Santander, 39008

  • Research Site

    Seville, 41013

  • Research Site

    Valencia, 46010

  • Research Site

    Zaragoza, 50009

Other trials in Spain

Greece6 sites

  • Research Site

    Athens, 11526

  • Research Site

    Athens, 11527

  • Research Site

    Athens, 155 62

  • Research Site

    Piraeus, 185 47

  • Research Site

    Thessaloniki, 55236

  • Research Site

    Thessaloniki, 57001

Other trials in Greece

Peru6 sites

  • Research Site

    Arequipa, 04002

  • Research Site

    Concepción, 12125

  • Research Site

    Lima, 15036

  • Research Site

    Lima, 34

  • Research Site

    Lima, LIMA 27

  • Research Site

    Lima, LIMA 29

Other trials in Peru

Taiwan6 sites

  • Research Site

    Hsinchu, 300

  • Research Site

    New Taipei City, 235

  • Research Site

    Taichung, 40705

  • Research Site

    Tainan, 73657

  • Research Site

    Taipei, 11217

  • Research Site

    Taoyuan, 333

Other trials in Taiwan

Sweden5 sites

  • Research Site

    Gävle, 801 88

  • Research Site

    Linköping, 581 85

  • Research Site

    Lund, 221 85

  • Research Site

    Stockholm, 17176

  • Research Site

    Uppsala, 751 85

Other trials in Sweden

Turkey (Türkiye)5 sites

  • Research Site

    Adana, 01060

  • Research Site

    Ankara, 06800

  • Research Site

    Edirne, 22030

  • Research Site

    Istanbul, 34098

  • Research Site

    Izmir, 35110

Other trials in Turkey (Türkiye)

Austria4 sites

  • Research Site

    Graz, 8036

  • Research Site

    Rankweil, 6830

  • Research Site

    Vienna, 1090

  • Research Site

    Vienna, 1210

Other trials in Austria

Mexico4 sites

  • Research Site

    Del. Cuauhtemoc, 06700

  • Research Site

    México, 14080

  • Research Site

    Mexico City, 03810

  • Research Site

    San Luis Potosí City, 78209

Other trials in Mexico

Bulgaria3 sites

  • Research Site

    Sofia, 1113

  • Research Site

    Sofia, 1330

  • Research Site

    Varna, 9010

Other trials in Bulgaria

Vietnam2 sites

  • Research Site

    Hanoi, 100000

  • Research Site

    Ho Chi Minh City, 700000

Other trials in Vietnam

About this study

Official title: A Phase III, Randomised, Open-label, Multicentre, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Durvalumab and Carboplatin Versus Pembrolizumab in Combination With Platinum-based Chemotherapy for the First-line Treatment of Patients With Locally Advanced or Metastatic NSCLC Without Actionable Genomic Alterations (D926NC00001; AVANZAR)

This is a Phase III, randomized, open-label, multicenter, global study to compare the efficacy and safety of Datopotamab Deruxtecan (Dato-DXd) in combination with durvalumab and carboplatin compared with pembrolizumab in combination with histology-specific platinum-based chemotherapy as first-line treatment of adults with stage IIIB, IIIC, or IV NSCLC without actionable genomic alterations (including sensitizing EGFR mutations, and ALK and ROS1 rearrangements).

Read the detailed description

Participants with locally advanced or metastatic NSCLC without actionable tumor tissue genomic alterations and confirmed to meet all eligibility criteria will be randomized in a 1:1 ratio to Dato-DXd in combination with durvalumab and carboplatin versus pembrolizumab in combination with histology-specific platinum-based chemotherapy as first-line treatment.

The primary objectives of the study are to demonstrate superiority of Dato-DXd in combination with durvalumab and carboplatin relative to pembrolizumab in combination with platinum-based chemotherapy by assessment of the following:

  1. PFS by BICR in first-line treatment of participants with non-squamous TROP2 biomarker positive locally-advanced or metastatic NSCLC
  2. OS in first-line treatment of participants with non-squamous TROP2 biomarker positive locally-advanced or metastatic NSCLC
  3. PFS by BICR in first-line treatment of participants with non-squamous locally-advanced or metastatic NSCLC
  4. OS in first-line treatment of participants with non-squamous locally-advanced or metastatic NSCLC
Conditions
NSCLC
Being tested
Datopotamab deruxtecan, Durvalumab, Carboplatin, Pembrolizumab, Cisplatin
Keywords
Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC), Datopotamab deruxtecan (Dato-DXd, Datroway), Durvalumab (Imfinzi), Carboplatin, Chemotherapy, Antibody-Drug Conjugate (ADC), Trophoblast cell surface protein 2 (TROP2)
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Datopotamab deruxtecanDrug

    Also called Dato-DXd, Datroway

    Intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.

  • DurvalumabDrug

    Also called MEDI4736, Imfinzi

    Intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.

  • CarboplatinDrug

    Intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles.

  • PembrolizumabDrug

    Intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle for a maximum of 35 cycles or 2 years (whichever occurs first).

  • CisplatinDrug

    Intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles.

  • PemetrexedDrug

    Intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.

  • PaclitaxelDrug

    Intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles.

Study groups in NCT05687266
Study groupRoleWhat they receive
Dato-DXd + Durvalumab + CarboplatinExperimentalParticipants will be randomized to receive 6.0mg/kg Dato-DXd plus 1120 mg durvalumab plus carboplatin area under the curve [AUC] 5 mg/mL/minute.
Receives: Drug: Datopotamab deruxtecan; Drug: Durvalumab; Drug: Carboplatin
Histologic-specific therapyActive comparatorNon-squamous NSCLC participants will be randomized to receive 200 mg pembrolizumab plus 500 mg/m2 pemetrexed plus either AUC 5 mg/mL/minute carboplatin or 75 mg/m2 cisplatin. Squamous NSCLC participants will be randomized to receive 200 mg of pembrolizumab plus 200 mg/m2 paclitaxel plus AUC 5 or 6 mg/mL/minute carboplatin.
Receives: Drug: Carboplatin; Drug: Pembrolizumab; Drug: Cisplatin; Drug: Pemetrexed; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (PFS) by blinded independent central review (BICR) in the non-squamous TROP2 biomarker positive population

    PFS is defined as time from randomisation until progression per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) as assessed by BICR, or death due to any cause.

    Measured: Approximately 3 years

  2. Overall Survival (OS) in the non-squamous TROP2 biomarker positive population

    OS is defined as the time from randomisation until the date of death due to any cause.

    Measured: Approximately 5 years

  3. PFS by BICR in the non-squamous population

    PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause.

    Measured: Approximately 3 years

  4. OS in the non-squamous population

    OS is defined as the time from randomisation until the date of death due to any cause.

    Measured: Approximately 5 years

Secondary outcomes (9)

  1. PFS by BICR in ITT and TROP2 biomarker-defined populations

    PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause.

    Measured: Approximately 3 years

  2. OS in ITT and TROP2 biomarker-defined populations

    OS is defined as the time from randomisation until the date of death due to any cause.

    Measured: Approximately 5 years

  3. Objective Response Rate (ORR) in ITT, non-squamous and TROP2 biomarker-defined populations

    ORR is defined as the proportion of participants who have a confirmed Complete Response (CR) or confirmed Partial Response (PR), as determined by BICR per RECIST 1.1.

    Measured: Approximately 5 years

  4. Duration of Response (DoR) in ITT, non-squamous and TROP2 biomarker-defined populations

    DoR is defined as the time from the date of first documented confirmed response until date of documented progression per RECIST 1.1, as assessed by BICR and investigator clinical assessment or death due to any cause.

    Measured: Approximately 5 years

  5. PFS by investigator in ITT, non-squamous and TROP2 biomarker-defined populations

    PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by investigator clinical assessment, or death due to any cause.

    Measured: Approximately 3 years

  6. Pharmacokinetics of Dato-DXd when combined with durvalumab and carboplatin.

    Concentration of Dato-DXd, total anti-TROP2 antibody, and DXd (payload deruxtecan) in plasma and pharmacokinetic (PK) parameters (such as peak and trough concentrations, as data allow; sparse sampling).

    Measured: Approximately 5 years

  7. Anti-Drug Antibody (ADA) for Dato-DXd

    The immunogenicity of Dato-DXd when combined with durvalumab and carboplatin.

    Measured: Approximately 5 years

  8. Time to Second Progression or Death (PFS2) in ITT, non-squamous and TROP2 biomarker-defined populations

    PFS2 is defined as the time from randomisation to the earliest of the progression events (following the initial progression), subsequent to first subsequent therapy, or death.

    Measured: Approximately 5 years

  9. Clinical Outcome Assessments in ITT, non-squamous and TROP2 biomarker-defined populations

    Clinical Outcome Assessments, such as TTD in pulmonary symptoms (dyspnoea, cough and chest pain) as measured by the NSCLC-SAQ, and TTD in physical functioning as measured by PROMIS Physical Function short form 8c

    Measured: Approximately 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2023
  2. Study start29 Dec 2022
  3. Primary completion1 Nov 2027 (estimated)
  4. Study completion1 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,350 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05687266
Sponsor's protocol ID
D926NC00001
Other IDs
2021-004606-21
Acronym
AVANZAR
Status last verified
Oct 2026
First submitted
28 Dec 2022
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Datopotamab deruxtecan, Durvalumab and Carboplatin in people with NSCLC, run by AstraZeneca at 254 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 254 sites in United States, China, Japan, France, Germany and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) by blinded independent central review (BICR) in the non-squamous TROP2 biomarker positive population (time frame: Approximately 3 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05687266.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.

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