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A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Locally Advanced or Metastatic Non-Squamous NSCLC
MinorTrial sites expanded: 295 → 300 locationsEligibility criteria expanded, about 16 words · Secondary endpoints: details revised at 3 of 10 entriesShow 2 more changesShow less
Eligibility criteria expanded, about 16 words
Secondary endpoints: details revised at 3 of 10 entries
MinorTrial sites expanded: 287 → 295 locationsv17
MinorEnrollment increased: 878 → 1160 participantsStudy sites: 286 to 287 · Secondary endpoints: details revised at 10 of 10 entries · Eligibility criteria expanded, about 4 words · 2 morev16Show 5 more changesShow less
Study sites: 286 to 287
Secondary endpoints: details revised at 10 of 10 entries
NotablePrimary completion pushed from May 10, 2029 to Nov 18, 2030Trial sites expanded: 283 → 286 locations · Completion pushed from Mar 25, 2030 to Nov 18, 2030v15Show 2 more changesShow less
Trial sites expanded: 283 → 286 locations
Completion pushed from Mar 25, 2030 to Nov 18, 2030
MinorStudy sites: 282 to 283v14
Show 12 earlier versionsHide 12 earlier versions
MinorSite details revised at 7 of 282 sitesv13
MinorStudy sites: 281 to 282v12
MinorStudy sites: 279 to 281v11
MinorStudy sites: 276 to 279v10
MinorStudy sites: 275 to 276v9
MinorSite details revised at 21 of 275 sitesv8
MinorStudy sites: 271 to 275v7
MinorStudy sites: 261 to 271v6
MinorStudy sites: 241 to 261Secondary endpoints: details revised at 1 of 10 entries · Eligibility criteria expanded, about 5 wordsv5Show 2 more changesShow less
Secondary endpoints: details revised at 1 of 10 entries
MinorStudy sites: 227 to 241Completion date: Mar 20, 2030 to Mar 25, 2030v4Show 1 more changeShow less
Completion date: Mar 20, 2030 to Mar 25, 2030
MinorStudy sites: 211 to 227Primary completion date: May 14, 2029 to May 10, 2029 · Completion date: Mar 25, 2030 to Mar 20, 2030v3Show 2 more changesShow less
Primary completion date: May 14, 2029 to May 10, 2029
Completion date: Mar 25, 2030 to Mar 20, 2030
NotableTrial status: Not Yet Recruiting to RecruitingStudy sites: 148 to 211 · Start date changed from estimate of Nov 29, 2024 to Nov 27, 2024 · Secondary endpoints: 11 to 10v2Show 3 more changesShow less
Study sites: 148 to 211
Start date changed from estimate of Nov 29, 2024 to Nov 27, 2024
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of ARTEMIDE-Lung03 is to evaluate the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line treatment of patients with locally advanced or metastatic non-squamous NSCLC whose tumors express PD-L1.