Phase III, Open-label Study of First-line Osimertinib With or Without Datopotamab Deruxtecan for EGFRm Locally Advanced or Metastatic Non-small Cell Lung Cancer (TROPION-Lung14)

A Phase III, Open-label, Randomised Study of Osimertinib With or Without Datopotamab Deruxtecan (Dato-DXd), as First-line Treatment in Participants With Epidermal Growth Factor Receptor (EGFR) Mutation-positive, Locally Advanced or Metastatic Non-small Cell Lung Cancer

The purpose of this study is to evaluate efficacy and safety of osimertinib (tablet) in combination with Dato-DXd (i.v. infusion) compared with osimertinib (tablet) monotherapyas a first-line therapy in participants with locally advanced or metastatic EGFRm (Ex19del and/or L858R) NSCLC.

Study details include:

1. The study duration will be event-driven, with an estimated duration of approximately 8 years.
2. Participants may receive study treatment until disease progression, unacceptable toxicity, or other specific discontinuation criteria are met.
3. The visit frequency will be every 3 weeks during the treatment period.

Note: Participants on osimertinib treatment(osimertinib only arm or who have discontinued Dato-DXd while are still receiving osimertinib) are required to attend visits to perform assessments every 6 weeks from Cycle 7 until Cycle 17 and then visits every 12 weeks until disease progression or IP discontinuation. Participants who are receiving osimertinib + Dato-DXd are still required to attend visit to perform assessment every 3 weeks (q3w) per SoA.

Study Overview

• Status: Recruiting
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Osimertinib; Drug: Datopotamab Deruxtecan

Detailed Description

This is a global Phase III, open-label, randomised, multicentre study assessing the efficacy and safety of osimertinib in combination with Datopotamab Deruxtecan compared with osimertinib in participants with locally advanced or metastatic EGFRm (Ex19del and/or L858R) NSCLC who have not received any prior therapy for advanced disease.

• Study Type: Interventional
• Enrollment (Estimated): 582
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• Australia
  • Camperdown, Australia, 2050
    • Recruiting
    • Research Site
  • Clayton, Australia, 3168
    • Recruiting
    • Research Site
  • Kogarah, Australia, 2217
    • Recruiting
    • Research Site
  • South Brisbane, Australia, 4101
    • Recruiting
    • Research Site
  • Westmead, Australia, 2145
    • Recruiting
    • Research Site
• Brazil
  • Barretos, Brazil, 14784-400
    • Recruiting
    • Research Site
  • Natal, Brazil, 59075-740
    • Recruiting
    • Research Site
  • Porto Alegre, Brazil, 91350-200
    • Recruiting
    • Research Site
  • Salvador, Brazil, 41253-190
    • Recruiting
    • Research Site
  • São Paulo, Brazil, 01246-000
    • Recruiting
    • Research Site
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Recruiting
      • Research Site
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • Recruiting
      • Research Site
• China
  • Beijing, China, 100029
    • Recruiting
    • Research Site
  • Beijing, China, 100034
    • Recruiting
    • Research Site
  • Beijing, China, 100142
    • Recruiting
    • Research Site
  • Changchun, China, 130000
    • Recruiting
    • Research Site
  • Changsha, China, 410013
    • Recruiting
    • Research Site
  • Chengdu, China, 610000
    • Recruiting
    • Research Site
  • Chengdu, China, 610072
    • Recruiting
    • Research Site
  • Chengdu, China, 610042
    • Recruiting
    • Research Site
  • Chongqing, China, 400030
    • Recruiting
    • Research Site
  • Chongqing, China, 402260
    • Recruiting
    • Research Site
  • Guangzhou, China, 510100
    • Recruiting
    • Research Site
  • Hangzhou, China, 310006
    • Recruiting
    • Research Site
  • Hangzhou, China, 310022
    • Recruiting
    • Research Site
  • Hangzhou, China, 31000
    • Recruiting
    • Research Site
  • Harbin, China, 150049
    • Recruiting
    • Research Site
  • Hefei, China, 230601
    • Recruiting
    • Research Site
  • Hefei, China, 230031
    • Recruiting
    • Research Site
  • Jinan, China, 250117
    • Recruiting
    • Research Site
  • Jinan, China, 250021
    • Recruiting
    • Research Site
  • Kunming, China, 650118
    • Recruiting
    • Research Site
  • Linhai, China, 317000
    • Recruiting
    • Research Site
  • Ningbo, China, 315010
    • Recruiting
    • Research Site
  • Shanghai, China, 200030
    • Recruiting
    • Research Site
  • Shanghai, China, 200433
    • Recruiting
    • Research Site
  • Shenyang, China, 110004
    • Recruiting
    • Research Site
  • Wenzhou, China, 325000
    • Recruiting
    • Research Site
  • Wuhan, China, 430022
    • Recruiting
    • Research Site
  • Wuhan, China, 430030
    • Recruiting
    • Research Site
  • Xi'an, China, 710061
    • Recruiting
    • Research Site
  • Xuzhou, China, 221000
    • Recruiting
    • Research Site
  • Yangzhou, China, 225001
    • Recruiting
    • Research Site
  • Zhengzhou, China, 450000
    • Recruiting
    • Research Site
  • Zhengzhou, China, 450008
    • Recruiting
    • Research Site
• France
  • Angers, France, 49055
    • Recruiting
    • Research Site
  • Marseille, France, 13915
    • Recruiting
    • Research Site
  • Paris, France, 75005
    • Recruiting
    • Research Site
  • Strasbourg, France, 67091, Cedex
    • Recruiting
    • Research Site
• Germany
  • Berlin, Germany, 13125
    • Recruiting
    • Research Site
  • Cologne, Germany, 51109
    • Recruiting
    • Research Site
  • Erfurt, Germany, 99089
    • Recruiting
    • Research Site
  • Frankfurt, Germany, 60488
    • Recruiting
    • Research Site
  • Göttingen, Germany, 37075
    • Withdrawn
    • Research Site
  • Immenhausen, Germany, 34376
    • Recruiting
    • Research Site
  • Kiel, Germany, 24105
    • Recruiting
    • Research Site
  • Mainz, Germany, 55131
    • Recruiting
    • Research Site
  • München, Germany, 81925
    • Recruiting
    • Research Site
• Hong Kong
  • Hong Kong, Hong Kong
    • Not yet recruiting
    • Research Site
  • Hong Kong, Hong Kong, 999077
    • Recruiting
    • Research Site
  • Jordan, Hong Kong, 999077
    • Recruiting
    • Research Site
  • Lai Chi Kok, Hong Kong
    • Not yet recruiting
    • Research Site
• India
  • Bangalore, India, 560027
    • Recruiting
    • Research Site
  • Delhi, India, 110085
    • Withdrawn
    • Research Site
  • Hyderabad, India, 500032
    • Recruiting
    • Research Site
  • Kolkata, India, 700054
    • Withdrawn
    • Research Site
  • Mysuru, India, 570017
    • Suspended
    • Research Site
  • Nagpur, India, 440001
    • Withdrawn
    • Research Site
  • Nashik, India, 422011
    • Recruiting
    • Research Site
  • New Delhi, India, 11029
    • Recruiting
    • Research Site
  • New Delhi, India, 100049
    • Withdrawn
    • Research Site
  • Vadodara, India, 391760
    • Recruiting
    • Research Site
  • Varanasi, India, 221005
    • Withdrawn
    • Research Site
• Italy
  • Milan, Italy, 20141
    • Recruiting
    • Research Site
  • Monza, Italy, 20900
    • Recruiting
    • Research Site
  • Orbassano, Italy, 10043
    • Recruiting
    • Research Site
  • Padova, Italy, 35128
    • Recruiting
    • Research Site
  • Parma, Italy, 43100
    • Recruiting
    • Research Site
• Japan
  • Chūōku, Japan, 104-0045
    • Recruiting
    • Research Site
  • Fukuoka, Japan, 812-8582
    • Recruiting
    • Research Site
  • Kashiwa, Japan, 277-8577
    • Recruiting
    • Research Site
  • Kōtoku, Japan, 135-8550
    • Recruiting
    • Research Site
  • Niigata, Japan, 951-8566
    • Recruiting
    • Research Site
  • Osaka, Japan, 541-8567
    • Recruiting
    • Research Site
  • Sakai, Japan, 590-0197
    • Recruiting
    • Research Site
  • Sapporo, Japan, 003-0804
    • Recruiting
    • Research Site
  • Sendai, Japan, 981-0914
    • Recruiting
    • Research Site
  • Wakayama, Japan, 641-8510
    • Recruiting
    • Research Site
  • Yokohama, Japan, 241-8515
    • Recruiting
    • Research Site
• Poland
  • Bystra, Poland, 43-360
    • Recruiting
    • Research Site
  • Olsztyn, Poland, 10-357
    • Recruiting
    • Research Site
  • Poznan, Poland, 60-569
    • Recruiting
    • Research Site
  • Warsaw, Poland, 02-781
    • Recruiting
    • Research Site
• Puerto Rico
  • Rio Piedras, Puerto Rico, 00935
    • Recruiting
    • Research Site
  • San Juan, Puerto Rico, 00918
    • Recruiting
    • Research Site
• South Korea
  • Goyang-si, South Korea, 410-769
    • Recruiting
    • Research Site
  • Namdong-gu, South Korea, 21565
    • Recruiting
    • Research Site
  • Seoul, South Korea, 03080
    • Recruiting
    • Research Site
  • Seoul, South Korea, 06351
    • Recruiting
    • Research Site
  • Seoul, South Korea, 120-752
    • Recruiting
    • Research Site
  • Suwon, South Korea, 16247
    • Recruiting
    • Research Site
• Spain
  • A Coruña, Spain, 15006
    • Recruiting
    • Research Site
  • Barcelona, Spain, 8036
    • Recruiting
    • Research Site
  • Granada, Spain, 18007
    • Recruiting
    • Research Site
  • Madrid, Spain, 28040
    • Recruiting
    • Research Site
  • Majadahonda, Spain, 28222
    • Recruiting
    • Research Site
  • Valencia, Spain, 46009
    • Recruiting
    • Research Site
• Taiwan
  • Taichung, Taiwan, 40705
    • Recruiting
    • Research Site
  • Tainan, Taiwan, 704
    • Recruiting
    • Research Site
  • Taipei, Taiwan, TAIWAN
    • Recruiting
    • Research Site
  • Taipei, Taiwan, 10002
    • Recruiting
    • Research Site
  • Taipei, Taiwan, 106
    • Recruiting
    • Research Site
  • Taoyuan, Taiwan, 333
    • Recruiting
    • Research Site
• Thailand
  • Bangkok, Thailand, 10400
    • Active, not recruiting
    • Research Site
  • Bangkok, Thailand, 10700
    • Active, not recruiting
    • Research Site
  • Dusit, Thailand, 10300
    • Active, not recruiting
    • Research Site
  • Hat Yai, Thailand, 90110
    • Recruiting
    • Research Site
  • Udon Thani, Thailand, 41000
    • Active, not recruiting
    • Research Site
• Turkey (Türkiye)
  • Adapazarı, Turkey (Türkiye), 54100
    • Recruiting
    • Research Site
  • Ankara, Turkey (Türkiye), 06530
    • Recruiting
    • Research Site
  • Goztepe Istanbul, Turkey (Türkiye)
    • Withdrawn
    • Research Site
  • Izmir, Turkey (Türkiye), 35100
    • Withdrawn
    • Research Site
  • Küçükçekmece, Turkey (Türkiye), 34295
    • Recruiting
    • Research Site
  • Seyhan, Turkey (Türkiye), 1060
    • Recruiting
    • Research Site
• United States
  • California
    • Fountain Valley, California, United States, 92708
      • Suspended
      • Research Site
    • Los Alamitos, California, United States, 90720
      • Recruiting
      • Research Site
    • Los Angeles, California, United States, 90017
      • Recruiting
      • Research Site
    • Los Angeles, California, United States, 90033
      • Recruiting
      • Research Site
    • Orange, California, United States, 92868
      • Not yet recruiting
      • Research Site
    • San Diego, California, United States, 92123
      • Recruiting
      • Research Site
    • Santa Monica, California, United States, 90404
      • Recruiting
      • Research Site
    • Walnut Creek, California, United States, 94598
      • Recruiting
      • Research Site
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Recruiting
      • Research Site
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20037
      • Withdrawn
      • Research Site
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Recruiting
      • Research Site
    • Ocala, Florida, United States, 34474
      • Recruiting
      • Research Site
    • Orange City, Florida, United States, 32763
      • Recruiting
      • Research Site
  • Hawaii
    • Honolulu, Hawaii, United States, 96819
      • Withdrawn
      • Research Site
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Withdrawn
      • Research Site
    • Hinsdale, Illinois, United States, 60521
      • Recruiting
      • Research Site
    • North Chicago, Illinois, United States, 60064
      • Recruiting
      • Research Site
  • Indiana
    • Fort Wayne, Indiana, United States, 46845
      • Recruiting
      • Research Site
  • Maryland
    • Bethesda, Maryland, United States, 20817
      • Recruiting
      • Research Site
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Recruiting
      • Research Site
  • Minnesota
    • Saint Paul, Minnesota, United States, 55102
      • Recruiting
      • Research Site
  • Missouri
    • Bridgeton, Missouri, United States, 63044
      • Withdrawn
      • Research Site
    • St Louis, Missouri, United States, 63110
      • Recruiting
      • Research Site
  • Nevada
    • Las Vegas, Nevada, United States, 89169
      • Recruiting
      • Research Site
  • New York
    • Brooklyn, New York, United States, 11212
      • Not yet recruiting
      • Research Site
    • New York, New York, United States, 10065
      • Recruiting
      • Research Site
  • Texas
    • Dallas, Texas, United States, 75390
      • Withdrawn
      • Research Site
    • Houston, Texas, United States, 77030
      • Recruiting
      • Research Site
    • Houston, Texas, United States, 77090
      • Withdrawn
      • Research Site
    • Webster, Texas, United States, 77598
      • Recruiting
      • Research Site
    • Woodway, Texas, United States, 76712
      • Recruiting
      • Research Site
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Recruiting
      • Research Site
    • Fort Belvoir, Virginia, United States, 22060
      • Recruiting
      • Research Site
    • Midlothian, Virginia, United States, 23114
      • Recruiting
      • Research Site
  • Washington
    • Seattle, Washington, United States, 98104
      • Withdrawn
      • Research Site
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Recruiting
      • Research Site
• Vietnam
  • Hanoi, Vietnam, 100000
    • Active, not recruiting
    • Research Site
  • Ho Chi Minh City, Vietnam, 700000
    • Active, not recruiting
    • Research Site
  • Ho Chi Minh City, Vietnam, 70000
    • Active, not recruiting
    • Research Site
  • Ho Chi Minh City, Vietnam
    • Active, not recruiting
    • Research Site
  • Hà Nội, Vietnam, 100000
    • Active, not recruiting
    • Research Site
  • Vinh, Vietnam, 460000
    • Active, not recruiting
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Age

1. Participant must be ≥ 18 years.

   Type of Participant and Disease Characteristics

2. Histologically or cytologically documented nonsquamous NSCLC. NSCLC of mixed histology is allowed if adenocarcinoma is the predominant histology. Mixed small-cell lung cancer and NSCLC histology, and sarcomatoid variant of NSCLC is ineligible.
3. Stage IIIB or IIIC or Stage IV metastatic NSCLC or recurrent NSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative surgery or definitive chemoradiation at the time of randomisation.
4. Participants must not have received prior EGFR TKIs or other systemic therapy for Stage IIIB, IIIC or IV NSCLC.
5. The tumour harbors at least 1 of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del or L858R), either alone or in combination with other genomic alterations, which may include EGFR T790M, assessed by a CLIA-certified (US sites) or an accredited (outside of the US) local laboratory or by central prospective tissue testing.
6. For participants enrolled in randomisation period, mandatory provision of an unstained, archival tumour tissue sample in a quantity sufficient to allow for central confirmation of the EGFR mutation status.
7. WHO performance status of 0 or 1.
8. At least one lesion not previously irradiated that qualifies as a RECIST 1.1 TL at baseline and can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes, which must have short axis ≥15 mm) with CT or MRI and is suitable for accurate repeated measurements.
9. Adequate bone marrow reserve and organ function before the first dose of study intervention.

Exclusion Criteria:

1. As judged by the investigator, any evidence of diseases (such as severe or uncontrolled systemic diseases, including active bleeding diseases, history of allogenic organ transplant which, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardise compliance with the protocol.
2. Refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption, distribution, metabolism, or excretion of osimertinib.
3. History of another primary malignancy.
4. Spinal cord compression and/or unstable brain metastases, as defined by Protocol.
5. Clinically significant corneal disease.
6. Has active or uncontrolled hepatitis B or C virus infection, as defined by Protocol.
7. Past medical history of ILD/penumonitis, including radiation pneumonitis (apart from radiation pneumonitis that did not require steroids), or drug-induced ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
8. Pulmonary embolism within 3 months of the study enrolment or has severe pulmonary function compromise.
9. Has clinically severe pulmonary function compromise resulting from intercurrent pulmonary illnesses.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: Osimertinib in combination with Datopotamab Deruxtecan; Participants in this group will receive osimertinib 80 mg QD as oral tablet with Datopotamab Deruxtecan 6mg/kg as i.v. infusion q3w of Day 1 of every 21-day cycle.	Drug: Osimertinib; Osimertinib 80 mg administered orally once daily (QD).; Other Names: Osimertinib: Tagrisso, AZD9291; Drug: Datopotamab Deruxtecan; Datopotamab Deruxtecan 6 mg/kg administered as an intravenous (i.v.) infusion every 3 weeks (q3w).; Other Names: Dato-DXd, DS-1062a
Active Comparator: Arm 2: Osimertinib monotherapy; Participants in this group will receive osimertinib 80 mg QD as oral tablet.	Drug: Osimertinib; Osimertinib 80 mg administered orally once daily (QD).; Other Names: Osimertinib: Tagrisso, AZD9291

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To demonstrate the superiority of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib by assessment of Progression Free Survival (PFS) by BICR in all randomised participants.	PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause (in the absence of progression).	It is anticipated that it will be performed approximately 3 years after the first participant is randomised.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To demonstrate the effectiveness of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib by assessment of PFS by investigator in all randomised participants.	PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by investigator, or death due to any cause (in the absence of progression).	It is anticipated that it will be performed approximately 3 years after the first participant is randomised.
To demonstrate the effectiveness of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib on the prevention of CNS metastases	Neuro-radiologist assessments according to CNS RECIST 1.1 to determine the presence/absence of CNS lesions at progression in participants without CNS metastases at baseline.	It is anticipated that it will be performed approximately 3 years after the first participant is randomised.
To compare the local EGFR mutation test result used for patient selection with the retrospective central cobas® EGFR Mutation Test v2 results from baseline tumour samples	Concordance of EGFR mutation status between the local EGFR mutation test and the central cobas® EGFR Mutation Test v2 results from tumour samples with evaluable results.	It is anticipated that it will be performed approximately 3 years after the first participant is randomised.
To demonstrate the superiority of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib by assessment of Overall Survival (OS) in all randomised participants.	OS defined as the time from randomisation until the date of death due to any cause.	It is anticipated that it will be performed approximately 7 years after the first participant has been randomised.
To demonstrate the effectiveness of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib by assessment of PFS on Central nervous system (CNS) metastases in participants with CNS metastases at baseline	Central nervous system progression-free survival (CNS PFS) is defined as the time from randomisation until the date of objective CNS progression assessed by CNS BICR or death (by any cause in absence of CNS progression).	It is anticipated that it will be performed approximately 3 years after the first participant is randomised.
To demonstrate the effectiveness of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib by assessment of Overall Response Rate (ORR) in all randomised participants with measurable disease at baseline.	ORR is defined as the proportion of participants who have a confirmed Complete Response (CR) or confirmed Partial Response (PR), as determined by BICR (and investigator) per RECIST 1.1.	It is anticipated that it will be performed approximately 3 years after the first participant is randomised.
To demonstrate the effectiveness of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib by assessment of Duration of Response (DoR) in all randomised participants with measurable disease at baseline.	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) assessment or death due to any cause. The measure of interest is the median of DoR.	It is anticipated that it will be performed approximately 3 years after the first participant is randomised.
To demonstrate the effectiveness of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib by assessment of PFS2 in all randomised participants	PFS2 will be defined as the time from randomisation to the earliest of the progression event (following the initial progression) subsequent to first subsequent anti-cancer therapy, or death.	It is anticipated that it will be analyzed by time of PFS primary which is about 3 years after the first participant has been randomised.
To investigate the immunogenicity of Datopotamab Deruxtecan	Presence of ADAs for Datopotamab Deruxtecan (confirmatory results: positive or negative, titres, and neutralizing antibodies).	It is anticipated that it will be performed approximately 3 years after the first participant has been randomised, together with PFS primary.
To demonstrate the effectiveness of osimertinib in combination with Datopotamab Deruxtecan vs. osimertinib monotherapy based on the cobas® EGFR Mutation Test v2 plasma screening test result for Ex19del or L858R EGFR mutations	PFS by Investigator by plasma EGFR mutation status PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by investigator, or death due to any cause (in the absence of progression).	It is anticipated that it will be performed approximately 3 years after the first participant has been randomised, together with PFS primary.
To assess the Pharmacokinetics (PK) of osimertinib and Datopotamab Deruxtecan	Concentration of osimertinib and its metabolite AZ5104, Datopotamab Deruxtecan, and DXd in plasma.	It is anticipated that it will be performed approximately 3 years after the first participant has been randomised.

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Daiichi Sankyo

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2024
• Primary Completion (Estimated): March 21, 2028
• Study Completion (Estimated): August 29, 2031

Study Registration Dates

• First Submitted: April 2, 2024
• First Submitted That Met QC Criteria: April 2, 2024
• First Posted (Actual): April 5, 2024

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Non-small Cell Lung Cancer, NSCLC, Epidermal Growth Factor Receptor (EGFR) Mutation-positive, Osimertinib, Dato-DXd, Datopotamab Deruxtecan, Tagrisso
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Tyrosine Kinase Inhibitors; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; osimertinib
• Other Study ID Numbers: D516NC00001; 2023-509883-89-00 (Other Identifier: EU CT 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.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

• 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 rerefer 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. 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