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Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer With or Without Actionable Genomic Alterations (TROPION-LUNG01)

StatusActive, Not Recruiting
PhasePhase 3
Started2020-12-21
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 51 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

2026-08-21
2 amendments v49-v50
2 re-verifications since 2026-07-29, no change to tracked fields
2026-03-03
Study Status v48
Completion date2026-01-31→2027-02-15
2026-01-16
3 amendments v45-v47
3 re-verifications since 2025-08-25, no change to tracked fields
2025-08-01
Study Identification, Study Status, Eligibility v44
Eligibility criteria+29 characters
[...] ve disease. Participants who have been treated with a prior tyrosine kinase inhibitor (TKI ) must receive additional approved targeted therapy, if local [...]
2025-07-23
Study Status v43
Re-verified, no change to tracked fields
Show 42 earlier versions
2025-07-22
Study Status, Outcome Measures (Results) v42
Results first postednot stated→2025-07-23
2025-07-16
2 amendments v40-v41
2 re-verifications since 2025-06-26, no change to tracked fields
2025-05-29
Study Status, Outcome Measures, Outcome Measures (Results), Adverse Events v39
Secondary endpointsdetails revised at 1 of 3 entries
2025-05-07
Study Status, Study Design, Outcome Measures, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Information v38
Enrollment targetestimated 590→confirmed 605
Secondary endpoints11 to 3 entries
Disease Control Rate (DCR) As Assessed by Blinded Independent Central Review (BICR) and Investigator As Per RECIST v1.1 Following DS-1062a Versus Docetaxel Time to Response (TTR) As Assessed by Blinded Independent Central Review (BICR) and Investigator As Per RECIST v1.1 Following DS-1062a Versus Do [...]
2025-03-25
Study Status v37
Completion date2025-06-21→2026-01-31
2025-02-12
4 amendments v33-v36
4 re-verifications since 2024-10-31, no change to tracked fields
2024-07-16
Study Status, Contacts/Locations v32
Study sites205→209
2024-07-08
Study Status v31
Completion date2024-06-27→2025-06-21
2024-05-20
Study Status v30
Re-verified, no change to tracked fields
2024-04-09
Study Status v29
Primary completion date2024-05-01→2024-05-10
2024-04-02
Study Status v28
Primary completion date2024-02-29→2024-05-01
2024-01-16
Study Status v27
Primary completion date2024-01→2024-02-29
2023-12-13
2 amendments v25-v26
2 re-verifications since 2023-11-16, no change to tracked fields
2023-10-11
Study Status, Contacts/Locations v24
Study sitesdetails revised at 6 of 205 sites
2023-09-12
Study Status v23
Re-verified, no change to tracked fields
2023-09-01
Study Status v22
Primary completion date2023-09-29→2024-01
2023-08-08
Study Status, Contacts/Locations v21
Study sites204→205
2023-06-30
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v20
Trial statusRecruiting→Active, Not Recruiting
Study sites219→204
2023-02-10
Study Status, Contacts/Locations v19
Study sitesdetails revised at 1 of 219 sites
2023-02-07
Study Status, Contacts/Locations v18
Study sites217→219
2022-11-10
Study Status, Contacts/Locations v17
Study sitesdetails revised at 172 of 217 sites
2022-11-02
Study Status, Contacts/Locations v16
Study sites216→217
2022-10-05
Study Status, Contacts/Locations v15
Study sites212→216
2022-09-14
Study Status, Contacts/Locations v14
Study sites204→212
2022-06-09
Study Status, Contacts/Locations, IPDSharing v13
Study sites199→204
2022-06-01
Study Status v12
Primary completion date2022-10-27→2023-09-29
2022-02-15
Study Identification, Study Status, Study Description, Eligibility, Contacts/Locations v11
Eligibility criteria+1,841 characters
[...] ts) Life expectancy ≥3 months Has pathologically documented NSCLC that: Has stageStage IIIB, IIIC, or stage IV NSCLC disease with or without actionable genomic alterations (AGA) at the time of randomization (based on the American Joint Committee on Cancer, Eighth Edition) and meets following criteria for NSCLC: HasParticipants without AGA: Must have documented negative test results for epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK). HasMust have no known genomic alterations in ROS proto-oncogene 1 (ROS1) [...] rosine receptor kinase (NTRK), proto oncogene B-raf (BRAF), m [...] [...]
Study description+307 characters
This study will evaluate DS-1062a 6.0 mg/kg vs docetaxel 75 mg/m^2 in participants with advanced or metastatic NSCLC with or without actionable genomic alterations and(AGAs). Participants whowithout actionable genomic alterations must have been previously treated with platinum-based chemotherapy and α (anti)-programmed cell death 1 (PD-1)/α-programmed cell death ligand 1 (PD-L1) monoclonal antibody, either in combination or sequentially. Participants with AGA must have progressed on or after 1 platinum-containing therapy and 1 to 2 prior lines of approved targeted therapy for the applicable ge [...] [...]
Study sitesdetails revised at 6 of 199 sites
Study title+8 characters
Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer With or Without Actionable Genomic Alterations (TROPION-LUNG01)
2022-01-05
Study Status, Contacts/Locations v10
Study sitesdetails revised at 6 of 199 sites
2021-12-06
Study Status, Contacts/Locations v9
Study sites198→199
2021-11-18
Study Status, Outcome Measures, Eligibility, Contacts/Locations v8
Eligibility criteria+143 characters
[...] rapy Includes participants who received prior platinum-based/chemotherapy chemo/with or without radiotherapy with maintenance α-PD-1/α-PD-L1 monoclonal anti [...] rapy Includes participants who received prior platinum-based/chemotherapy chemo/with or without radiotherapy (with or without maintenance α-PD-1/α-PD-L1 mon [...] entially as the only 2 prior lines of therapy Must undergo a mandatory pre-treatment tumor biopsy procedure or, if available, tumor tissue previously retrieved from a tumor biopsy procedure performed within 2 years prior to the participant signing informed consent and that washas recentl [...] [...]
Secondary endpoints11 entries, revised
EuropeanTime Organizationto for Research and Treatment of CancerDeterioration (EORTC) Core Quality of Life Questionnaire (QLQ) and EORTC Quality of Life Questionnaire (QLQ) for Lung Cancer Trials Scores (Except Questions 36 and 37TTD) Following DS-1062a Versus Docetaxel
Study sitesdetails revised at 50 of 198 sites
2021-10-12
Study Status, Contacts/Locations v7
Study sites197→198
2021-09-08
Study Status, Contacts/Locations v6
Study sitesdetails revised at 7 of 197 sites
2021-08-09
Study Status, Contacts/Locations v5
Study sites195→197
2021-07-12
Study Status, Contacts/Locations v4
Study sites194→195
2021-05-11
Study Status, Contacts/Locations v3
Study sitesdetails revised at 8 of 194 sites
2021-04-13
Study Identification, Study Status, Conditions, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v2
Study sites163→194
Eligibility criteria+537 characters
[...] ths Has pathologically documented NSCLC that: Has stage IIIB, IIIC, or stage IV NSCLC disease at the time of randomization (bas [...] apy Includes participants who received prior platinum-based chemoradiotherapychemo/radiotherapy with maintenance α-PD-1/α-PD-L1 monoclonal antibody for Sta [...] apy Includes participants who received prior platinum-based chemoradiotherapychemo/radiotherapy (with or without maintenance α-PD-1/α-PD-L1 monoclonal anti [...] er order) sequentially as the only 2 prior lines of therapy Willing and able toMust undergo a mandatory pre-treatment tumor biopsy procedure or, if available, a tu [...] [...]
Secondary endpoints10 to 11 entries
Progression-free Survival (PFS) As Assessed by Investigator Per RECIST v1.1 Following DS-1062a Versus Docetaxel Objective Response Rate (ORR) As Assessed by Blinded Independent Central Review (BICR) and Investigator As Per RECIST v1.1 Following DS-1062a Versus Docetaxel Duration of Response (DOR) As Assessed by Blinded Independent Central Review (BICR) and Investigator As Per RECIST v1.1 Following DS-1062a Versus Docetaxel Disease Control Rate (DCR) As Assessed by Blinded Independent Central Review (BICR) and Investigator As Per RECIST v1.1 Following DS-1062a Versus Docetaxel Time to Response [...] [...]
Primary endpoints2 entries, revised
Progression-free Survival (PFS) As Assessed by InvestigatorBlinded Independent Central Review (BICR) Per RECIST v1.1 Following DS-1062a Versus Docetaxel
Study titlerevised
Study of DS-1062A1062a Versus Docetaxel in Previously Treated Advanced or Metastat [...]
2021-01-28
Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2020-12-14→confirmed 2020-12-21
Study sites0→163
This study will evaluate the efficacy, safety, and pharmacokinetics of DS-1062a versus docetaxel in participants with previously treated advanced or metastatic non-small cell lung cancer (NSCLC) with or without actionable genomic alterations.
Trial Details
NCT Number NCT04656652
Lead Sponsor Daiichi Sankyo
Collaborators: AstraZeneca
Conditions Non-small Cell Lung Cancer
Enrollment 605 participants
Start Date 2020-12-21
Primary Completion 2024-05-10 (estimated)
Study Completion 2027-02-15 (estimated)
Updated on ClinicalTrials.gov 2026-08-26