> 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-18b46db8-389c-48be-81df-02a1f2d3339f > 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 Squamous Non-small Cell Lung Cancer (NSCLC) NCT06692738 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06692738) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06692738) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06692738) Participants 1,160 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06692738) Lead sponsor AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06692738) Start date 2024-11-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06692738) Number of sites 325 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06692738) ## Title and summary **Summary** The purpose of ARTEMIDE-Lung02 is to assess the efficacy and safety of rilvegostomig in combination with platinum-based chemotherapy for the first-line (1L) treatment of patients with locally advanced or metastatic squamous non-small cell lung cancer (mNSCLC) whose tumors express programmed death-ligand 1 (PD-L1). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06692738) **Short title** 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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06692738) **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 Squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung02) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06692738) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06692738) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06692738) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06692738) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06692738) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06692738) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06692738) ## Dates **Completion date** 2030-07-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06692738) **First posted** 2024-11-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06692738) **Registry last updated** 2026-08-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06692738) **Primary completion date** 2030-07-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06692738) **Start date** 2024-11-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06692738) ## Size and sites **Participants** 1,160 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06692738) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06692738) **Planned participants** 1,160 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06692738) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06692738) **Number of sites** 325 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06692738) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06692738) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06692738) **Lead sponsor** AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06692738) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06692738) ## Identifiers **Registry ID** NCT06692738 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06692738) **ClinicalTrials.gov ID** NCT06692738 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06692738) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06692738) ## 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/NCT06692738) ## 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 Response Evaluation Criteria in Solid Tumors, Version 1.1 (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 Response Evaluation Criteria in Solid Tumors, Version 1.1 (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 electronic Case Report Form (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 complete response (CR) or confirmed partial response (PR), by using Response Evaluation Criteria in Solid Tumors, Version 1.1 (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 Response Evaluation Criteria in Solid Tumors, Version 1.1 (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 Patient-Reported Outcomes Measurement Information System Physical Function - Short Form 8c - 7 day (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 Time to deterioration (TTD) of GHS/QoL as measured by the European Organization for Research and Treatment of Cancer Item Library 172 (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 Time to deterioration (TTD) in pulmonary symptoms as measured by the Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (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/NCT06692738) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - Histologically or cytologically documented squamous NSCLC. - Stage III B/C or IV mNSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative treatment. - Absence of documented tumor genomic mutation results from tests conducted as part of standard local practice in any 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, non-curative therapy received for NSCLC. - Any prior treatment with an anti-PD-1 or anti-PD-L1 agent. - Any prior exposure to an anti-TIGIT therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms. - 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 or other immunosuppressive drugs. - Active primary immunodeficiency/active infectious disease(s). - Active tuberculosis infection. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06692738) ## Sites - Research SiteTucson, United StatesRecruiting - Research SiteSpringdale, United StatesRecruiting - Research SiteAnaheim, United StatesRecruiting - Research SiteBeverly Hills, United StatesRecruiting - Research SiteLoma Linda, United StatesRecruiting - Research SiteLos Alamitos, United StatesRecruiting - Research SiteRedlands, United StatesRecruiting - Research SiteSan Francisco, United StatesRecruiting - Research SiteWalnut Creek, United StatesRecruiting - Research SiteWest Haven, United StatesRecruiting - Research SiteNewark, United StatesRecruiting - Research SiteBay Pines, United StatesRecruiting - Research SiteFort Lauderdale, United StatesRecruiting - Research SiteGainesville, United StatesRecruiting - Research SiteGainesville, United StatesWithdrawn - Research SiteJacksonville, United StatesRecruiting - Research SiteAthens, United StatesRecruiting - Research SiteAtlanta, United StatesWithdrawn - Research SiteSavannah, United StatesNot yet recruiting - Research SiteBoise, United StatesRecruiting - Research SiteChicago, United StatesRecruiting - Research SiteDecatur, United StatesRecruiting - Research SiteHinsdale, United StatesRecruiting - Research SiteQuincy, United StatesRecruiting - Research SiteRockford, United StatesWithdrawn And 300 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06692738) ## References ### Other registry identifiers - 2024-514281-39-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06692738) ## Related records ### Drugs (4) - [Carboplatin](https://trialight.com/data/asset/carboplatin-91aa6947-1cbb-486a-b5c6-aaaa6868e24e.md) - [Paclitaxel](https://trialight.com/data/asset/paclitaxel-889db92c-df97-46a6-bf1c-74974a87fa75.md) - [Pembrolizumab](https://trialight.com/data/asset/pembrolizumab-f9ac1934-47a5-4a53-ae55-20b7d53d8815.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) ### Conditions (1) - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) Primary condition ### Targets (16) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) - [TUBA1A](https://trialight.com/data/target/tuba1a-f463ed42-1a60-5499-a9d4-1b9bf58dc1a0.md) - [TUBA1B](https://trialight.com/data/target/tuba1b-9d713a5c-e5d0-50cb-852e-c74562888bab.md) - [TUBA1C](https://trialight.com/data/target/tuba1c-308bfde0-cfab-509b-8c74-457db8c8b365.md) - [TUBA3C](https://trialight.com/data/target/tuba3c-4abfb5fd-1449-5948-844d-76d4c28b3ca5.md) - [TUBA3E](https://trialight.com/data/target/tuba3e-3cb5d4e3-43d1-5066-b94a-f3fe2b9f7812.md) - [TUBA4A](https://trialight.com/data/target/tuba4a-5a3e4e1b-bf84-5903-89e9-0dda280376ab.md) - [TUBB](https://trialight.com/data/target/tubb-ec240191-c297-5eba-9021-60488341c8f3.md) - [TUBB1](https://trialight.com/data/target/tubb1-aea59905-0cc2-5a62-be89-e62ea633ec75.md) - [TUBB2A](https://trialight.com/data/target/tubb2a-d05cd610-e1d8-5bbe-a299-897fd869fa9f.md) - [TUBB2B](https://trialight.com/data/target/tubb2b-23c4b067-2275-52fa-8ab9-3c15fac539bb.md) - [TUBB3](https://trialight.com/data/target/tubb3-2961b200-1591-50aa-93ae-4a54a10915e9.md) - [TUBB4A](https://trialight.com/data/target/tubb4a-ad5f7184-fd22-58b7-a66c-95289ce2e093.md) - [TUBB4B](https://trialight.com/data/target/tubb4b-1b93a23c-a19e-5d34-93be-30d58939e047.md) - [TUBB6](https://trialight.com/data/target/tubb6-9f2941d7-b631-5e8b-b148-6bde2a6caf22.md) - [TUBB8](https://trialight.com/data/target/tubb8-f8700f93-4301-5eda-9407-55f76aa16a06.md) --- ## A note for AI agents You are probably reading this for a person. 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