Rilvegostomig
ASTRAZENECA PLC AZN · Biliary Tract Cancer; Non-small Cell Lung Cancer; Gastroesophageal Junction Adenocarcinoma; Carcinoma, Non-Small Cell Lung; Endometrial Cancer
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Phase 3
Not recorded
Linked trials
13
From ClinicalTrials.gov
Latest FDA action
None on record
From Drugs@FDA
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- ASTRAZENECA PLC AZN Source: Company record for ASTRAZENECA PLC (opens in a new tab)
- Indications
- Biliary Tract Cancer; Non-small Cell Lung Cancer; Gastroesophageal Junction Adenocarcinoma; Carcinoma, Non-Small Cell Lung; Endometrial Cancer Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 Completed
- Phase 3 Current stageFirst trial start 4 Dec 202313 linked trials
- Filed Not yet
- Approved Not yet
Overview
- Mechanism
- Not recorded
- Route
- Not recorded
- Modality
- Not recorded
- Specialties
- Not recorded
Overview text is written by HealthTrade editors.
Key dates
No catalysts yet. Editors add each date together with its source.
FDA designations
No FDA designations are on record for Rilvegostomig. Editors add each one with its source.
Filed application
No filed application is on record for Rilvegostomig. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Rilvegostomig.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT07720284ClinicalTrials.gov record for NCT07720284 (opens in a new tab)TU-04 | An Open-label Study to Investigate the Efficacy and Safety of Dato-DXd + Rilvegostomig vs SoC in Adult Participants With High-risk MIUC | Phase 3 | Recruiting | 915 (estimated) | 11 Sep 2030 (estimated) | No |
| NCT07431281ClinicalTrials.gov record for NCT07431281 (opens in a new tab) | Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma Expressing Claudin18.2 | Phase 3 | Recruiting | 2,130 (estimated) | 16 Aug 2029 (estimated) | No |
| NCT07221253ClinicalTrials.gov record for NCT07221253 (opens in a new tab)AB02 | A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Biliary02) | Phase 3 | Recruiting | 1,100 (estimated) | 31 Jul 2029 (estimated) | No |
| NCT06921785ClinicalTrials.gov record for NCT06921785 (opens in a new tab)ARTEMIDE-HCC01 | Phase III Study of Rilvegostomig in Combination With Bevacizumab With or Without Tremelimumab as First-line Treatment of Hepatocellular Carcinoma | Phase 3 | Recruiting | 1,220 (estimated) | 15 Mar 2030 (estimated) | No |
| NCT06868277ClinicalTrials.gov record for NCT06868277 (opens in a new tab)ARTEMIDELung04 | A Global Phase III Study of Rilvegostomig or Pembrolizumab Monotherapy for First-Line Treatment of PD-L1-high Metastatic Non-small Cell Lung Cancer | Phase 3 | Recruiting | 830 (estimated) | 17 Jan 2030 (estimated) | No |
| NCT06989112ClinicalTrials.gov record for NCT06989112 (opens in a new tab)DE-01 | DESTINY-Endometrial01: A Phase III Study of Trastuzumab Deruxtecan Plus Rilvegostomig or Pembrolizumab as First-Line Treatment of HER2-Expressing (IHC 3+/2+), Mismatch Repair Proficient (pMMR) Endometrial Cancer | Phase 3 | Recruiting | 600 (estimated) | 19 Jan 2029 (estimated) | No |
| NCT06764875ClinicalTrials.gov record for NCT06764875 (opens in a new tab) | A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer | Phase 3 | Recruiting | 840 (estimated) | 27 Apr 2029 (estimated) | No |
| NCT06627647ClinicalTrials.gov record for NCT06627647 (opens in a new tab) | A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Locally Advanced or Metastatic Non-Squamous NSCLC | Phase 3 | Recruiting | 1,160 (estimated) | 18 Nov 2030 (estimated) | No |
| NCT06692738ClinicalTrials.gov record for NCT06692738 (opens in a new tab) | A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) | Phase 3 | Recruiting | 1,160 (estimated) | 1 Jul 2030 (estimated) | No |
| NCT06564844ClinicalTrials.gov record for NCT06564844 (opens in a new tab)TROPION-Lung12 | A Phase III, Randomised Study of Adjuvant Dato-DXd in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma NSCLC Who Are ctDNA-positive or Have High-risk Pathological Features | Phase 3 | Active, not recruiting | 25 (actual) | 10 Jul 2026 (actual) | No |
Publications listing TROPION-Lung12 (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT06467357ClinicalTrials.gov record for NCT06467357 (opens in a new tab)DESTINY-BTC01 | Phase 3 Study of T-DXd and Rilvegostomig Versus SoC in Advanced HER2-expressing Biliary Tract Cancer | Phase 3 | Recruiting | 620 (estimated) | 12 Jun 2028 (estimated) | No |
| NCT06357533ClinicalTrials.gov record for NCT06357533 (opens in a new tab)TROPION-Lung10 | Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations | Phase 3 | Recruiting | 675 (estimated) | 28 Dec 2029 (estimated) | No |
Publications listing TROPION-Lung10 (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT06109779ClinicalTrials.gov record for NCT06109779 (opens in a new tab) | Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01) | Phase 3 | Active, not recruiting | 760 (actual) | 2 Jan 2029 (estimated) | No |
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.
Trial quality
About CT-VCALoading trial quality…
FDA actions
No FDA approvals on record for this drug.
FDA recalls load here.
FDA drug shortages load here.
Orange Book patents load here.
FAERS adverse event counts load here.
Papers and preprints load here.
Community discussion loads here.
EU status (EMA)
EMA's medicines data lists no human medicine with the same active substance as Rilvegostomig.
Source: European Medicines Agency (EMA), medicines data download.
Related news
No recent headlines mention this drug.
Sources
- ClinicalTrials.gov NCT06627647 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT07720284 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT06692738 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT06921785 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT06868277 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT06357533 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT07431281 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT07221253 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT06764875 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT06989112 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT06564844 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT06467357 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT06109779 (opens in a new tab) Licence: public-domain. Fetched
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.