> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-global-phase-iii-study-of-rilvegostomig-or-pembrolizumab-2214dc53-fd67-4cf8-80fd-2e328685ed0a > Record changed: 2026-10-13 # A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Locally Advanced or Metastatic Non-Squamous NSCLC NCT06627647 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06627647) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06627647) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06627647) Participants 1,160 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06627647) Lead sponsor AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06627647) Start date 2024-11-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06627647) Number of sites 295 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06627647) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06627647) **Short title** A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Locally Advanced or Metastatic Non-Squamous NSCLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06627647) **Official title** A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab in Combination With Platinum-based Chemotherapy for the First-line Treatment of Patients With Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung03) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06627647) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06627647) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06627647) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06627647) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06627647) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06627647) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06627647) ## Dates **Completion date** 2030-11-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06627647) **First posted** 2024-10-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06627647) **Registry last updated** 2026-08-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06627647) **Primary completion date** 2030-11-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06627647) **Start date** 2024-11-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06627647) ## Size and sites **Participants** 1,160 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06627647) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06627647) **Planned participants** 1,160 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06627647) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06627647) **Number of sites** 295 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06627647) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06627647) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06627647) **Lead sponsor** AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06627647) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06627647) ## Identifiers **Registry ID** NCT06627647 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06627647) **ClinicalTrials.gov ID** NCT06627647 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06627647) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06627647) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masking description** Double-blind masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06627647) ## Outcomes ### Primary outcomes 1. Overall survival (OS) Timeframe: Up to approximately 6 years OS is defined as the time from randomization until the date of death due to any cause. 2. Progression-free survival (PFS) Timeframe: Up to approximately 6 years PFS is defined as the time from randomization until radiological progression per RECIST 1.1, or death due to any cause (in the absence of progression). ### Secondary outcomes 1. Landmark overall survival (OS) rates Timeframe: Up to approximately 6 years OS is defined as the time from randomization until the date of death due to any cause. 2. Landmark progression-free survival (PFS) rates Timeframe: Up to approximately 6 years PFS is defined as the time from randomization until radiological progression per RECIST 1.1, or death due to any cause (in the absence of progression). 3. Time to second progression or death (PFS2) Timeframe: Up to approximately 6 years PFS2 is defined as the time from randomization until the earliest of the progression event (following the initial progression event), after the start of the first subsequent therapy, or death from any cause, whichever occurs first. The date of the second progression will be recorded by the investigator in the eCRF and defined according to local standard clinical practice. 4. Overall response rate (ORR) Timeframe: Up to approximately 6 years ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, using RECIST 1.1. 5. Duration of response (DoR) Timeframe: Up to approximately 6 years DoR is defined as the time from the date of first documented response until the date of documented progression using RECIST 1.1 or death due to any cause (in the absence of progression). 6. Pharmacokinetic (PK) of rilvegostomig Timeframe: Up to approximately 6 years Concentration of rilvegostomig in serum 7. Immunogenicity of rilvegostomig Timeframe: Up to approximately 6 years Presence of antidrug antibodies (ADAs), titer, and neutralizing antibodies for rilvegostomig 8. Patient-reported physical functioning Timeframe: Up to approximately 6 years Proportion of participants with maintained or improved physical functioning as measured by PROMIS PF-SF 8c - 7 day at each time point. 9. Patient-reported global health status (GHS)/quality of life (QoL) Timeframe: Up to approximately 6 years TTD of GHS/QoL as measured by the EORTC IL172\. TTD is defined as time from randomization to the date of first deterioration. Deterioration is defined as a worsening change from baseline that reaches a clinically meaningful change threshold. 10. Patient-reported lung cancer symptoms of non-small cell lung cancer (NSCLC) Timeframe: Up to approximately 6 years TTD in pulmonary symptoms as measured by the NSCLC-SAQ. TTD is defined as time from randomization to the date of first deterioration. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06627647) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - Histologically or cytologically documented non-squamous NSCLC. - Stage III B/C or IV NSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative treatment. - Absence of sensitizing EGFR mutations (including, but not limited to, exon 19 deletion and exon 21 L858R, exon 21 L861Q, exon 18 G719X, and exon 20 S768I mutations) and ALK and ROS1 rearrangements. - Absence of documented tumor genomic mutation results from tests conducted as part of standard local practice in any other actionable driver oncogenes for which there are locally approved and available targeted 1L therapies. - Provision of acceptable tumor sample, to confirm tumor PD-L1 expression TC ≥ 1%. - 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. - Adequate organ and bone marrow function ### Exclusion criteria - Presence of small cell and neuroendocrine histology components. - Brain metastases unless asymptomatic, stable, and not requiring steroids or anticonvulsants for at least 7 days prior to randomization. A minimum of 2 weeks must have elapsed between the end of local therapy (brain radiotherapy or surgery) and randomization. Participants must have recovered from the acute toxic effect of radiotherapy (eg, dizziness and signs of increased intracranial pressure) or surgery prior to randomization. - Any prior systemic therapy received for NSCLC except in the neoadjuvant or adjuvant setting or definitive chemoradiotherapy with the intent to cure, provided that progression has occurred > 12 months after the end of systemic therapy treatment. - Any prior exposure to an anti-TIGIT therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms. - Any prior treatment with an anti-PD-1 or anti-PD-L1 agent. - History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence. - Active or prior documented autoimmune or inflammatory disorders requiring chronic systemic treatment with the use of disease-modifying agents, corticosteroids, or immunosuppressive drugs. - Active primary immunodeficiency/active infectious disease(s). - Active tuberculosis infection. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06627647) ## Sites - Research SiteMobile, United StatesRecruiting - Research SiteChandler, United StatesWithdrawn - Research SitePhoenix, United StatesRecruiting - Research SiteAnaheim, United StatesRecruiting - Research SiteBeverly Hills, United StatesRecruiting - Research SiteLoma Linda, United StatesRecruiting - Research SiteRedlands, United StatesRecruiting - Research SiteSan Diego, United StatesRecruiting - Research SiteSan Francisco, United StatesRecruiting - Research SiteSanta Rosa, United StatesRecruiting - Research SiteWalnut Creek, United StatesRecruiting - Research SiteLone Tree, United StatesRecruiting - Research SiteStamford, United StatesRecruiting - Research SiteWest Haven, United StatesRecruiting - Research SiteNewark, United StatesRecruiting - Research SiteBay Pines, United StatesRecruiting - Research SiteFort Lauderdale, United StatesRecruiting - Research SiteGainesville, United StatesWithdrawn - Research SiteJacksonville, United StatesRecruiting - Research SiteMiami, United StatesRecruiting - Research SiteOcala, United StatesRecruiting - Research SiteSt. Petersburg, United StatesRecruiting - Research SiteAtlanta, United StatesWithdrawn - Research SiteBoise, United StatesRecruiting - Research SiteChicago, United StatesRecruiting And 270 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06627647) ## References ### Other registry identifiers - 2024-515008-38-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06627647) ## Related records ### Drugs (5) - [Carboplatin](https://trialight.com/data/asset/carboplatin-91aa6947-1cbb-486a-b5c6-aaaa6868e24e.md) - [Cisplatin](https://trialight.com/data/asset/cisplatin-e039621a-d679-4740-88ac-94842bf4a91e.md) - [Pembrolizumab](https://trialight.com/data/asset/pembrolizumab-f9ac1934-47a5-4a53-ae55-20b7d53d8815.md) - [Pemetrexed](https://trialight.com/data/asset/pemetrexed-2221859e-676b-4d76-97df-e11f3f9664a1.md) - [Rilvegostomig](https://trialight.com/data/asset/rilvegostomig-00c6e431-24ca-4fba-9919-bbbb6f9171d5.md) ### Lead sponsors (1) - [AstraZeneca](https://trialight.com/data/company/astrazeneca-347ee8c0-c709-4614-b67b-0061b353dff7.md) ### Targets (4) - [DHFR](https://trialight.com/data/target/dhfr-e77e5dcd-f4e0-5e26-b456-0a5b230a72b3.md) - [GART](https://trialight.com/data/target/gart-01a731ec-9c88-556f-8fc6-2217fab015bc.md) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) - [TYMS](https://trialight.com/data/target/tyms-8b1d20f5-3314-546a-bd58-610c1db66b0f.md) --- ## A note for AI agents You are probably reading this for a person. 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