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Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in 1L Non-Small Cell Lung Cancer (TROPION-Lung07)

StatusActive, Not Recruiting
PhasePhase 3
Started2023-01-11
View on ClinicalTrials.gov ↗

Amendment history

2026-06-22
Study Status, Contacts/Locations v27
Trial sites expanded: 254 → 260 locations
Completion pushed: 2029-05-11 → 2031-05-11
2026-03-24
Study Identification, Study Status v26
Re-verified, no change to tracked fields
2026-02-17
Study Identification, Study Status, Study Description, Outcome Measures, Eligibility v25
Primary completion date2027-08-01→2029-05-11
Completion date2027-08-01→2029-05-11
Eligibility criteria+26 characters
[...] PD-L1 IHC 22C3 pharmDx assay by central testing (minimum of six6 slides). PD-L1 expression results available at the same cen [...] I TROP2-targeted therapy Any anti-PD-1, anti-PD-L1, or anti-programmed death-ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or c [...] ICIs Subjects who received adjuvant or neoadjuvant therapy OTHERother than those listed above are eligible if the adjuvant/neoadj [...]
Secondary endpoints10 to 11 entries
Objective Response Rate by Blinded Independent Central Review in All Randomized Participants Objective Response Rate by Blinded Independent Central Review in All Randomized Participants Withwho Advancedare orTROP2 MetastaticNMR Non Small Cell Lung Cancer (NSCLC)positive Progression-free Survival by Investigator in Both All Randomized Participants Withand AdvancedRandomized orParticipants Metastaticwho Nonare SmallTROP2 CellNMR Lung Cancer (NSCLC)positive Objective Response Rate by Investigator in Both All Randomized Participants Withand AdvancedRandomized orParticipants Metastaticwho Nonare Sm [...] [...]
Primary endpoints2 to 4 entries
Overall Survival in All Randomized Participants Overall Survival in All Randomized Participants Withwho Advancedare orTROP2 MetastaticNMR Non Small Cell Lung Cancer (NSCLC)positive Progression-free Survival Based on Blinded Independent Central Review in All Randomized Participants Progression-free Survival Based on Blinded Independent Central Review in All Randomized Participants Withwho Advancedare orTROP2 MetastaticNMR Non Small Cell Lung Cancer (NSCLC)positive
Study description+100 characters
[...] or metastatic NSCLC without actionable genomic alternations, as well as participants who are TROP2 NMR+ at baseline. TROP2 NMR will be retrospectively assessed. Eligible participants will be randomized in a 1:1:1 ratio to [...]
2026-01-09
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v24
Trial statusRecruiting→Active, Not Recruiting
Study sites252→254
2025-09-09
Study Status, Contacts/Locations v23
Study sites247→252
Show 22 earlier versions
2025-06-25
Study Status, Contacts/Locations v22
Study sites240→247
2025-04-18
Study Status, Contacts/Locations v21
Study sites241→240
2025-04-17
Study Status, Contacts/Locations v20
Study sites216→241
2025-03-04
Study Status, Contacts/Locations v19
Study sites210→216
2024-11-11
Study Status, Contacts/Locations v18
Study sites211→210
2024-11-05
Study Identification, Study Status, Study Design, Arms and Interventions, Eligibility, Contacts/Locations v17
Primary completion date2027-08→2027-08-01
Completion date2027-08→2027-08-01
Enrollment target975→1170
Study sites206→211
Eligibility criteria+1,629 characters
Key Inclusion Criteria: Sign and date the Main Informed Consent Form (ICF), prior to the start of any study- specific qualification procedures. Is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions. Adults ≥18 at the time the Main ICF is signed. (Follow local regulatory requirements if the legal age of adult voluntary consent for study participation is >18 years old). Has tumor with PD-L1 TPS <50% as determined by PD-L1 IHC 22C3 pharmDx assay by central testing (minimum of six slides). PD-L1 expression re [...] [...]
2024-08-29
Study Status, Contacts/Locations v16
Study sites201→206
2024-07-11
Study Status, Contacts/Locations v15
Study sites192→201
2024-05-30
Study Status, Contacts/Locations v14
Study sites191→192
2024-05-17
Study Status, Contacts/Locations v13
Study sites140→191
2024-04-10
Study Status, Contacts/Locations v12
Study sites99→140
2023-12-01
Study Status, Contacts/Locations v11
Study sites101→99
2023-11-29
Study Status, Contacts/Locations v10
Study sites99→101
2023-11-14
Study Status, Contacts/Locations v9
Study sites57→99
2023-08-11
Study Status, Eligibility, Contacts/Locations v8
Study sites48→57
Eligibility criteria+12 characters
[...] any of the following, including in the adjuvant/neoadjuvant (for NSCLC) setting: Any agent, including an antibody-drug conjugate, co [...]
2023-06-26
Study Status, Contacts/Locations v7
Study sites44→48
2023-05-06
Study Status, Contacts/Locations v6
Study sites30→44
2023-04-20
Study Identification, Study Status v5
Re-verified, no change to tracked fields
2023-04-10
Study Status, Contacts/Locations v4
Study sites18→30
2023-03-01
Study Status, Contacts/Locations v3
Study sites12→18
2023-02-03
Study Status, Contacts/Locations v2
Study sites4→12
2023-01-13
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-11→confirmed 2023-01-11
Study sites0→4
2022-09-22
Original filing
This study is designed to assess the efficacy and safety of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab versus pembrolizumab in combination with pemetrexed and platinum chemotherapy in participants with no prior therapy for advanced or metastatic non-squamous non-small cell lung cancer (NSCLC).
Trial Details
NCT Number NCT05555732
Lead Sponsor Daiichi Sankyo
Collaborators: AstraZeneca, Merck Sharp & Dohme LLC
Conditions Metastatic Non Small Cell Lung Cancer
Enrollment 1,170 participants
Start Date 2023-01-11
Primary Completion 2029-05-11 (estimated)
Study Completion 2031-05-11 (estimated)
Updated on ClinicalTrials.gov 2026-06-23