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

April 21, 2026 updated by: AstraZeneca

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

1350

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Research Site
      • Rankweil, Austria, 6830
        • Research Site
      • Vienna, Austria, 1090
        • Research Site
      • Vienna, Austria, 1210
        • Research Site
  • Brazil
      • Blumenau, Brazil, 89010-340
        • Research Site
      • Florianópolis, Brazil, 88034-000
        • Research Site
      • Fortaleza, Brazil, 60336-045
        • Research Site
      • Londrina, Brazil, 86015-520
        • Research Site
      • Porto Alegre, Brazil, 90035-903
        • Research Site
      • São Paulo, Brazil, 01246-000
        • Research Site
      • São Paulo, Brazil, 01509-900
        • Research Site
      • São Paulo, Brazil, 09323-900
        • Research Site
      • São Paulo, Brazil, 01327-001
        • Research Site
      • Taubaté, Brazil, 12030-200
        • Research Site
      • Vitória, Brazil, 29043-260
        • Research Site
  • Bulgaria
      • Sofia, Bulgaria, 1330
        • Research Site
      • Sofia, Bulgaria, 1113
        • Research Site
      • Varna, Bulgaria, 9010
        • Research Site
  • Canada
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L 4L2
        • Research Site
    • Ontario
      • Brampton, Ontario, Canada, L6R 3J7
        • Research Site
      • Greater Sudbury, Ontario, Canada, P3E 5J1
        • Research Site
      • Kitchener, Ontario, Canada, N2G 1G3
        • Research Site
      • Newmarket, Ontario, Canada, L3Y 2P9
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Research Site
      • Montreal, Quebec, Canada, H4J 1C5
        • Research Site
      • Montreal, Quebec, Canada, H1T 2M4
        • Research Site
      • Saint-Jérôme, Quebec, Canada, J7Z 5T3
        • Research Site
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Research Site
  • China
      • Beijing, China, 100853
        • Research Site
      • Beijing, China, 100037
        • Research Site
      • Beijing, China, 100029
        • Research Site
      • Beijing, China, 100039
        • Research Site
      • Beijing, China, CN-100730
        • Research Site
      • Beijing, China, 100010
        • Research Site
      • Changsha, China, 410013
        • Research Site
      • Changsha, China, 410008
        • Research Site
      • Chengdu, China, 610041
        • Research Site
      • Chengdu, China, 610072
        • Research Site
      • Chongqing, China, 400037
        • Research Site
      • Guangzhou, China, 510000
        • Research Site
      • Guangzhou, China, 510100
        • Research Site
      • Hefei, China, 230601
        • Research Site
      • Jinan, China, 250021
        • Research Site
      • Kunming, China, 650101
        • Research Site
      • Lanzhou, China, 730000
        • Research Site
      • Liuchow, China, 545006
        • Research Site
      • Shandong, China
        • Research Site
      • Shanghai, China, 200032
        • Research Site
      • Shanghai, China, 200080
        • Research Site
      • Shanghai, China, 200030
        • Research Site
      • Shantou, China, 515041
        • Research Site
      • Shenyang, China, 110004
        • Research Site
      • Shenzhen, China, 517108
        • Research Site
      • Taiyuan, China, 030000
        • Research Site
      • Tianjin, China, 300060
        • Research Site
      • Wenzhou, China, 325000
        • Research Site
      • Wuhan, China, 430030
        • Research Site
      • Wuhan, China, 430060
        • Research Site
      • Xiamen, China, 361004
        • Research Site
      • Yangzhou, China, 225001
        • Research Site
      • Zhengzhou, China, 450052
        • Research Site
  • France
      • Brest, France, 29200
        • Research Site
      • Créteil, France, 94010
        • Research Site
      • Gleizé, France, 69400
        • Research Site
      • Montpellier, France, 34070
        • Research Site
      • Nîmes, France, 30029
        • Research Site
      • Paris, France, 75018
        • Research Site
      • Paris, France, 75674
        • Research Site
      • Rouen, France, 76031
        • Research Site
      • Saint-Quentin, France, 02321
        • Research Site
      • Strasbourg, France, 67091
        • Research Site
      • Toulon, France, 83800
        • Research Site
      • Toulouse, France, 31059
        • Research Site
      • Tours, France, 37000
        • Research Site
  • Germany
      • Bad Berka, Germany, 99437
        • Research Site
      • Berlin, Germany, 14109
        • Research Site
      • Frankfurt A. Main, Germany, 60590
        • Research Site
      • Gauting, Germany, 82131
        • Research Site
      • Gütersloh, Germany, 33332
        • Research Site
      • Hamburg, Germany, 20251
        • Research Site
      • Kassel, Germany, 34125
        • Research Site
      • Kiel, Germany, 24116
        • Research Site
      • Koblenz, Germany, 56073
        • Research Site
      • Minden, Germany, 32429
        • Research Site
      • Rosenheim, Germany, 83022
        • Research Site
      • Velbert, Germany, 42551
        • Research Site
      • Würzburg, Germany, 97074
        • Research Site
  • Greece
      • Athens, Greece, 11527
        • Research Site
      • Athens, Greece, 11526
        • Research Site
      • Athens, Greece, 155 62
        • Research Site
      • Piraeus, Greece, 185 47
        • Research Site
      • Thessaloniki, Greece, 57001
        • Research Site
      • Thessaloniki, Greece, 55236
        • Research Site
  • Hungary
      • Budapest, Hungary, 1121
        • Research Site
      • Budapest, Hungary, 1122
        • Research Site
      • Gyöngyös - Mátraháza, Hungary, 3200
        • Research Site
      • Kaposvár, Hungary, 7400
        • Research Site
      • Pécs, Hungary, 7624
        • Research Site
      • Szekszárd, Hungary, 7100
        • Research Site
      • Szolnok, Hungary, 5000
        • Research Site
      • Törökbálint, Hungary, 2045
        • Research Site
  • India
      • Calicut, India, 673601
        • Research Site
      • Delhi, India, 110085
        • Research Site
      • Delhi, India, 110029
        • Research Site
      • Jaipur, India, 302017
        • Research Site
      • Kolkata, India, 700160
        • Research Site
      • Madurai, India, 625107
        • Research Site
      • Puducherry, India, 605006
        • Research Site
  • Italy
      • Florence, Italy, 50134
        • Research Site
      • Lecco, Italy, 23900
        • Research Site
      • Messina, Italy, 98158
        • Research Site
      • Naples, Italy, 80131
        • Research Site
      • Orbassano, Italy, 10043
        • Research Site
      • Padova, Italy, 35128
        • Research Site
      • Parma, Italy, 43126
        • Research Site
      • Peschiera del Garda, Italy, 37019
        • Research Site
      • Rozzano, Italy, 20089
        • Research Site
  • Japan
      • Bunkyō City, Japan, 113-8603
        • Research Site
      • Chūōku, Japan, 104-0045
        • Research Site
      • Hamamatsu, Japan, 431-3192
        • Research Site
      • Hamamatsu, Japan, 432-8580
        • Research Site
      • Hidaka-shi, Japan, 350-1298
        • Research Site
      • Hirosaki-shi, Japan, 036-8563
        • Research Site
      • Hiroshima, Japan, 730-8518
        • Research Site
      • Kumamoto, Japan, 860-8556
        • Research Site
      • Nagoya, Japan, 466-8560
        • Research Site
      • Nagoya, Japan, 464-8681
        • Research Site
      • Okayama, Japan, 700-8558
        • Research Site
      • Osaka, Japan, 545-8586
        • Research Site
      • Osakasayama-shi, Japan, 589-8511
        • Research Site
      • Sapporo, Japan, 060-8638
        • Research Site
      • Sunto-gun, Japan, 411-8777
        • Research Site
      • Wakayama, Japan, 641-8510
        • Research Site
      • Yokohama, Japan, 241-8515
        • Research Site
      • Yokohama, Japan, 221-0855
        • Research Site
  • Mexico
      • Del. Cuauhtemoc, Mexico, 06700
        • Research Site
      • Mexico City, Mexico, 03810
        • Research Site
      • México, Mexico, 14080
        • Research Site
      • San Luis Potosí City, Mexico, 78209
        • Research Site
  • Peru
      • Arequipa, Peru, 04002
        • Research Site
      • Concepción, Peru, 12125
        • Research Site
      • Lima, Peru, LIMA 27
        • Research Site
      • Lima, Peru, LIMA 29
        • Research Site
      • Lima, Peru, 15036
        • Research Site
      • Lima, Peru, 34
        • Research Site
  • Poland
      • Bydgoszcz, Poland, 85-796
        • Research Site
      • Bystra, Poland, 43-360
        • Research Site
      • Grudziądz, Poland, 86-300
        • Research Site
      • Kielce, Poland, 25-734
        • Research Site
      • Koszalin, Poland, 75-581
        • Research Site
      • Olsztyn, Poland, 10-357
        • Research Site
      • Poznan, Poland, 60-569
        • Research Site
      • Przemyśl, Poland, 37-700
        • Research Site
      • Racibórz, Poland, 47-400
        • Research Site
      • Radom, Poland, 26-600
        • Research Site
      • Siedlce, Poland, 08-110
        • Research Site
  • South Korea
      • Busan, South Korea, 48108
        • Research Site
      • Cheongju-si, South Korea, 28644
        • Research Site
      • Jinju, South Korea, 52727
        • Research Site
      • Seoul, South Korea, 03080
        • Research Site
      • Seoul, South Korea, 03722
        • Research Site
      • Seoul, South Korea, 05505
        • Research Site
      • Seoul, South Korea, 06351
        • Research Site
      • Seoul, South Korea, 07061
        • Research Site
      • Suwon, South Korea, 16499
        • Research Site
      • Suwon, South Korea, 16247
        • Research Site
  • Spain
      • Las Palmas de Gran Canaria, Spain, 35016
        • Research Site
      • Lugo, Spain, 27003
        • Research Site
      • Madrid, Spain, 28041
        • Research Site
      • Santander, Spain, 39008
        • Research Site
      • Seville, Spain, 41013
        • Research Site
      • Valencia, Spain, 46010
        • Research Site
      • Zaragoza, Spain, 50009
        • Research Site
  • Sweden
      • Gävle, Sweden, 801 88
        • Research Site
      • Linköping, Sweden, 581 85
        • Research Site
      • Lund, Sweden, 221 85
        • Research Site
      • Stockholm, Sweden, 17176
        • Research Site
      • Uppsala, Sweden, 751 85
        • Research Site
  • Taiwan
      • Hsinchu, Taiwan, 300
        • Research Site
      • New Taipei City, Taiwan, 235
        • Research Site
      • Taichung, Taiwan, 40705
        • Research Site
      • Tainan, Taiwan, 73657
        • Research Site
      • Taipei, Taiwan, 11217
        • Research Site
      • Taoyuan District, Taiwan, 333
        • Research Site
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 01060
        • Research Site
      • Ankara, Turkey (Türkiye), 06800
        • Research Site
      • Edirne, Turkey (Türkiye), 22030
        • Research Site
      • Istanbul, Turkey (Türkiye), 34098
        • Research Site
      • Izmir, Turkey (Türkiye), 35110
        • Research Site
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZN
        • Research Site
      • Cambridge, United Kingdom, CB2 0QQ
        • Research Site
      • Cardiff, United Kingdom, CF14 2TL
        • Research Site
      • Cheltenham, United Kingdom, GL53 7AN
        • Research Site
      • Edinburgh, United Kingdom, EH4 2XU
        • Research Site
      • London, United Kingdom, W6 8RF
        • Research Site
      • London, United Kingdom, SE1 9RT
        • Research Site
      • Manchester, United Kingdom, M20 4BX
        • Research Site
      • Middlesbrough, United Kingdom, TS4 3BW
        • Research Site
      • Newcastle upon Tyne, United Kingdom, NE7 7DN
        • Research Site
      • Taunton, United Kingdom, TA1 5DA
        • Research Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Research Site
      • Tucson, Arizona, United States, 85704
        • Research Site
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Research Site
      • Little Rock, Arkansas, United States, 72205
        • Research Site
      • Springdale, Arkansas, United States, 72762
        • Research Site
    • California
      • Fountain Valley, California, United States, 92708
        • Research Site
      • Los Angeles, California, United States, 90017
        • Research Site
      • Orange, California, United States, 92868
        • Research Site
    • Colorado
      • Boulder, Colorado, United States, 80303
        • Research Site
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Research Site
      • Jacksonville, Florida, United States, 32224
        • Research Site
      • St. Petersburg, Florida, United States, 33705
        • Research Site
      • West Palm Beach, Florida, United States, 33401
        • Research Site
    • Illinois
      • Hinsdale, Illinois, United States, 60521
        • Research Site
    • Indiana
      • Fort Wayne, Indiana, United States, 46845
        • Research Site
    • Iowa
      • Bettendorf, Iowa, United States, 52722
        • Research Site
      • Iowa City, Iowa, United States, 52242
        • Research Site
      • Waukee, Iowa, United States, 50263
        • Research Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Research Site
      • Covington, Louisiana, United States, 70433
        • Research Site
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • Research Site
      • Rochester, Minnesota, United States, 55905
        • Research Site
    • Missouri
      • Hannibal, Missouri, United States, 63401
        • Research Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68516
        • Research Site
      • Lincoln, Nebraska, United States, 68506
        • Research Site
    • New York
      • Clifton Park, New York, United States, 12065
        • Research Site
    • North Carolina
      • Asheville, North Carolina, United States, 28806
        • Research Site
    • Ohio
      • Canton, Ohio, United States, 44710
        • Research Site
      • Columbus, Ohio, United States, 43219
        • Research Site
      • Maumee, Ohio, United States, 43537
        • Research Site
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74134
        • Research Site
    • Oregon
      • Portland, Oregon, United States, 97239
        • Research Site
      • Salem, Oregon, United States, 97301
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Research Site
      • Philadelphia, Pennsylvania, United States, 19104
        • Research Site
      • Philadelphia, Pennsylvania, United States, 19111
        • Research Site
      • York, Pennsylvania, United States, 17403
        • Research Site
    • South Dakota
      • Watertown, South Dakota, United States, 57201
        • Research Site
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Research Site
    • Texas
      • Dallas, Texas, United States, 75246
        • Research Site
      • Fort Worth, Texas, United States, 76104
        • Research Site
      • Houston, Texas, United States, 77030
        • Research Site
      • Houston, Texas, United States, 77090
        • Research Site
      • Irving, Texas, United States, 75063
        • Research Site
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Research Site
      • Henrico, Virginia, United States, 23229
        • Research Site
      • Norfolk, Virginia, United States, 23502
        • Research Site
    • Washington
      • Renton, Washington, United States, 98055
        • Research Site
      • Spokane, Washington, United States, 99202
        • Research Site
      • Tacoma, Washington, United States, 98405
        • Research Site
    • Wisconsin
      • Appleton, Wisconsin, United States, 54911
        • Research Site
      • La Crosse, Wisconsin, United States, 54601
        • Research Site
  • Vietnam
      • Hanoi, Vietnam, 100000
        • Research Site
      • Ho Chi Minh City, Vietnam, 700000
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 130 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion:

  • 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

Exclusion:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dato-DXd + Durvalumab + Carboplatin
Participants 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.
Drug: Datopotamab deruxtecan
Intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Other Names:
  • Dato-DXd, Datroway
Drug: Durvalumab
Intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Other Names:
  • MEDI4736, Imfinzi
Drug: Carboplatin
Intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles.
Active Comparator: Histologic-specific therapy

Non-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.
Drug: Carboplatin
Intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles.
Drug: Pembrolizumab
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).
Other Names:
  • Keytruda
Drug: Cisplatin
Intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles.
Drug: Pemetrexed
Intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.
Other Names:
  • Alimta, Pemfexy
Drug: Paclitaxel
Intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles.
Other Names:
  • Taxol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS) by blinded independent central review (BICR) in the non-squamous TROP2 biomarker positive population
Time Frame: Approximately 3 years
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.
Approximately 3 years
PFS by BICR in the non-squamous population
Time Frame: Approximately 3 years
PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause.
Approximately 3 years
Overall Survival (OS) in the non-squamous TROP2 biomarker positive population
Time Frame: Approximately 5 years
OS is defined as the time from randomisation until the date of death due to any cause.
Approximately 5 years
OS in the non-squamous population
Time Frame: Approximately 5 years
OS is defined as the time from randomisation until the date of death due to any cause.
Approximately 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS by BICR in ITT and TROP2 biomarker-defined populations
Time Frame: Approximately 3 years
PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause.
Approximately 3 years
PFS by investigator in ITT, non-squamous and TROP2 biomarker-defined populations
Time Frame: Approximately 3 years
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.
Approximately 3 years
OS in ITT and TROP2 biomarker-defined populations
Time Frame: Approximately 5 years
OS is defined as the time from randomisation until the date of death due to any cause.
Approximately 5 years
Objective Response Rate (ORR) in ITT, non-squamous and TROP2 biomarker-defined populations
Time Frame: Approximately 5 years
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.
Approximately 5 years
Duration of Response (DoR) in ITT, non-squamous and TROP2 biomarker-defined populations
Time Frame: Approximately 5 years
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.
Approximately 5 years
Pharmacokinetics of Dato-DXd when combined with durvalumab and carboplatin.
Time Frame: Approximately 5 years
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).
Approximately 5 years
Anti-Drug Antibody (ADA) for Dato-DXd
Time Frame: Approximately 5 years
The immunogenicity of Dato-DXd when combined with durvalumab and carboplatin.
Approximately 5 years
Time to Second Progression or Death (PFS2) in ITT, non-squamous and TROP2 biomarker-defined populations
Time Frame: Approximately 5 years
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.
Approximately 5 years
Clinical Outcome Assessments in ITT, non-squamous and TROP2 biomarker-defined populations
Time Frame: Approximately 5 years
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
Approximately 5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of Dato-DXd in combination with durvalumab and carboplatin
Time Frame: Approximately 5 years
Safety and tolerability will be evaluated in terms of AEs (graded by CTCAE Version 5.0).
Approximately 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Chair: Charu Aggarwal, Perelman Center for Advanced Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 29, 2022

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

December 28, 2022

First Submitted That Met QC Criteria

January 17, 2023

First Posted (Actual)

January 18, 2023

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D926NC00001
  • 2021-004606-21 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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