Sponsor: AstraZeneca (industry)
Phase: 3
Start date: Nov. 27, 2024
Planned enrollment: 878
Rilvegostomig (AZD2936) is an investigational bispecific monoclonal antibody from AstraZeneca that targets PD‑1 and TIGIT. It is being studied across multiple tumor types, with ongoing phase 3 programs including first‑line metastatic non‑squamous NSCLC (ARTEMIDE‑Lung03), adjuvant biliary tract cancer after resection (ARTEMIDE‑Biliary01), first‑line advanced hepatocellular carcinoma (ARTEMIDE‑HCC01), and first‑line HER2‑positive, PD‑L1–positive gastric/GEJ cancer (ARTEMIDE‑Gastric01). (cdek.pharmacy.purdue.edu)
NSCLC (ARTEMIDE‑01, Phase I/II)
Ongoing phase 3 studies (no efficacy readouts yet)
Notes: Human efficacy data to date are from phase I/II NSCLC cohorts; phase 3 trials listed above are ongoing without reported outcomes as of October 7, 2025. (cdek.pharmacy.purdue.edu)
Last updated: Oct 2025
Goal: Evaluate whether rilvegostomig combined with platinum-based doublet chemotherapy improves efficacy and maintains acceptable safety compared with pembrolizumab plus the same chemotherapy as first-line therapy for metastatic non-squamous NSCLC with PD-L1 expression.
Patients: Adults with histologically or cytologically confirmed stage IV non-squamous NSCLC, PD-L1 tumor cell expression ≥1%, at least one measurable non-irradiated lesion, adequate organ function, and no actionable driver alterations for which first-line targeted therapy is approved (eg, sensitizing EGFR, ALK, ROS1, and other locally targetable oncogenes). Excludes small cell/neuroendocrine components, active/unstable brain metastases, prior systemic therapy for advanced disease, prior PD-1/PD-L1 or TIGIT therapies, clinically significant autoimmune disease requiring chronic immunosuppression, primary immunodeficiency, active serious infections including tuberculosis, and recent other active malignancies.
Design: Global, multicenter, randomized, double-blind, active-controlled Phase III trial with two arms comparing an investigational checkpoint combination agent to standard pembrolizumab, both given with platinum-pemetrexed induction and pemetrexed-maintenance plus assigned immunotherapy. Planned enrollment approximately 878 participants.
Treatments: Arm A: Rilvegostomig plus platinum-based doublet chemotherapy (cisplatin or carboplatin with pemetrexed) followed by maintenance rilvegostomig plus pemetrexed. Arm B: Pembrolizumab plus the same platinum doublet followed by maintenance pembrolizumab plus pemetrexed. Rilvegostomig (AZD2936) is a humanized bispecific IgG1 monoclonal antibody targeting PD-1 and TIGIT to enhance antitumor T-cell activity; its Fc region is engineered to reduce effector functions. Early-phase data in heavily pretreated NSCLC showed acceptable tolerability with mostly grade 1–3 immune-related AEs and preliminary antitumor activity, including confirmed partial responses and stable disease, with a recommended dose of 750 mg and high peripheral PD-1/TIGIT receptor occupancy. Pembrolizumab with platinum-pemetrexed is a standard first-line regimen for metastatic non-squamous NSCLC without targetable alterations.
Outcomes: Primary endpoints: overall survival and progression-free survival per RECIST 1.1. Key secondary endpoints include landmark OS and PFS rates, time to second progression (PFS2), overall response rate, duration of response, pharmacokinetics and immunogenicity of rilvegostomig, and patient-reported outcomes including physical functioning (PROMIS PF-SF 8c), global health status/quality of life (EORTC IL172), and lung cancer symptoms (NSCLC-SAQ). Follow-up is up to approximately 5 years.
Burden on patient: Moderate. The treatment backbone (platinum-pemetrexed with maintenance pemetrexed) mirrors standard first-line care, with routine imaging and clinic visits for infusions every 3 weeks during induction and maintenance. Additional burden arises from mandatory baseline tumor tissue submission for PD-L1 confirmation and exploratory analyses, and from serial pharmacokinetic and immunogenicity blood draws for participants receiving rilvegostomig. Double-blind procedures and long-term follow-up over several years entail regular visits and assessments, but no extra invasive procedures beyond standard-of-care imaging and laboratory monitoring are anticipated.
Last updated: Oct 2025
Inclusion Criteria:
* Histologically or cytologically documented non-squamous NSCLC.
* Stage IV mNSCLC (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 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 advanced or mNSCLC. Prior systemic therapy in the neoadjuvant or adjuvant setting and/or definitive radio- or chemoradiotherapy for early-stage disease are allowed, provided that recurrence or progression has occurred \> 12 months after the end of 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 treatment with steroids or other immunosuppressive treatment.
* Active primary immunodeficiency/active infectious disease(s).
* Active tuberculosis infection.
Buenos Aires, C1431FWO, Argentina
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Osaka, 541-8567, Japan
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Saitama-shi, 338-0001, Japan
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Sunto-gun, 411-8777, Japan
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Shinjuku-ku, 160-0023, Japan
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Kumamoto, 860-8556, Japan
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Matsusaka-shi, 515-8544, Japan
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Ota-shi, 373-8550, Japan
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Amagasaki-shi, 660-8550, Japan
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Bunkyō City, 113-8603, Japan
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Chūōku, 104-0045, Japan
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Fukuoka, 812-8582, Japan
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Fukuoka, 814-0180, Japan
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Hiroshima, 734-8551, Japan
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Kawagoe-shi, 350-8550, Japan
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Kitaadachi-gun, 362-0806, Japan
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Kitakyushu-shi, 807-8555, Japan
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Kobe, 650-0017, Japan
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Petaling Jaya, 47500, Malaysia
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Seyhan, 1060, Turkey (Türkiye)
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Edirne, 22030, Turkey (Türkiye)
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London, SE1 9RT, United Kingdom
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London, EC1A 7BE, United Kingdom
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Rochester, Minnesota, 55905, United States
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Bridgeton, Missouri, 63044, United States
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Lincoln, Nebraska, 68506, United States
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Westbury, New York, 11590, United States
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Salem, Oregon, 97301, United States
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Nashville, Tennessee, 37203, United States
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Palestine, Texas, 75801, United States
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Spokane, Washington, 99208, United States
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Tacoma, Washington, 98405, United States
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Silverdale, Washington, 98383, United States
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Vinh, 460000, Vietnam
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Hanoi, 100000, Vietnam
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Can Tho, 900000, Vietnam
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Jinan, 250117, China
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Charleroi, 6060, Belgium
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Kortrijk, 8500, Belgium
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Ottignies, 1340, Belgium
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Sault Ste. Marie, Ontario, P6A 0A8, Canada
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Rennes, 35033, France
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Bad Berka, 99437, Germany
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Moers, 47441, Germany
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Budapest, 1083, Hungary
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Gyöngyös - Mátraháza, 3200, Hungary
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Budapest, 1121, Hungary
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Győr, 9024, Hungary
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Mumbai, 400012, India
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Kolkata, 700054, India
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Varanasi, 221005, India
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Ede, 6716 RP, Netherlands
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Veldhoven, 5504 DB, Netherlands
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Warsaw, 04-141, Poland
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Bystra, 43-360, Poland
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San Juan, 00935, Puerto Rico
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San Juan, 00918, Puerto Rico
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Izmir, 35965, Turkey (Türkiye)
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Manchester, M20 4BX, United Kingdom
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Chandler, Arizona, 85224, United States
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Loma Linda, California, 92350, United States
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Redlands, California, 92373, United States
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San Francisco, California, 94121, United States
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West Haven, Connecticut, 06516, United States
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St. Petersburg, Florida, 33709, United States
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Ocala, Florida, 34474, United States
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Miami, Florida, 33125, United States
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Fort Lauderdale, Florida, 33308, United States
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Boise, Idaho, 83712, United States
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Hinsdale, Illinois, 60521, United States
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Quincy, Illinois, 62305, United States
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Lexington, Kentucky, 40536, United States
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Lexington, Kentucky, 40509, United States
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Louisville, Kentucky, 40207, United States
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Alexandria, Louisiana, 71301, United States
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Status: Not yet recruiting
Baton Rouge, Louisiana, 70808, United States
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South Portland, Maine, 04106, United States
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Camden, New Jersey, 08103, United States
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Buffalo, New York, 14221, United States
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Medford, Oregon, 97504, United States
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Round Rock, Texas, 78665, United States
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Status: Not yet recruiting
Seattle, Washington, 98101, United States
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Status: Not yet recruiting
La Plata, 1900, Argentina
No email / No phone
Status: Withdrawn
Sint-Niklaas, 9100, Belgium
No email / No phone
Status: Withdrawn
São Paulo, 01246-000, Brazil
No email / No phone
Status: Withdrawn
Taubaté, 12030-200, Brazil
No email / No phone
Status: Withdrawn
Sydney, Nova Scotia, B1P 1P3, Canada
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Status: Withdrawn
Gyöngyös, 3200, Hungary
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Status: Withdrawn
Székesfehérvár, 8000, Hungary
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Status: Withdrawn
Groningen, 9713 GZ, Netherlands
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Status: Withdrawn
Lima, Lima 34, Peru
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Status: Withdrawn
Lima, 15036, Peru
No email / No phone
Status: Withdrawn
Lima, 15102, Peru
No email / No phone
Status: Withdrawn
Lima, LIMA 29, Peru
No email / No phone
Status: Withdrawn
Exeter, EX2 5DW, United Kingdom
No email / No phone
Status: Withdrawn
Gainesville, Florida, 32610, United States
No email / No phone
Status: Withdrawn
Atlanta, Georgia, 30342, United States
No email / No phone
Status: Withdrawn
Rockford, Illinois, 61114, United States
No email / No phone
Status: Withdrawn
Duluth, Minnesota, 55805, United States
No email / No phone
Status: Withdrawn
Columbia, Missouri, 65212, United States
No email / No phone
Status: Withdrawn
Portland, Oregon, 97239, United States
No email / No phone
Status: Withdrawn
Providence, Rhode Island, 02903, United States
No email / No phone
Status: Withdrawn
Lubbock, Texas, 79410, United States
No email / No phone
Status: Withdrawn
Houston, Texas, 77090, United States
No email / No phone
Status: Withdrawn
Seattle, Washington, 98104, United States
No email / No phone
Status: Withdrawn
Wenatchee, Washington, 98801, United States
No email / No phone
Status: Withdrawn
La Crosse, Wisconsin, 54601, United States
No email / No phone
Status: Withdrawn
Bydgoszcz, 85-796, Poland
No email / No phone
Status: SUSPENDED
Biała Podlaska, 21-500, Poland
No email / No phone
Status: SUSPENDED
Pittsburgh, Pennsylvania, 15212, United States
No email / No phone
Status: SUSPENDED