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 Metastatic Non-squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung03)

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Investigational drug late phase More information Active drug More information Moderate burden on patient More information

Trial Details

Sponsor: AstraZeneca (industry)

Phase: 3

Start date: Nov. 27, 2024

Planned enrollment: 878

Trial ID: NCT06627647
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More trial details at ClinicalTrials.gov More info

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chevron Show for: Rilvegostomig (AZD2936)

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Goal: To compare the efficacy and safety of rilvegostomig versus pembrolizumab, both in combination with platinum-based chemotherapy, as first-line treatment for patients with metastatic non-squamous non-small cell lung cancer (NSCLC) expressing PD-L1.

Patients: Adults with stage IV, non-squamous metastatic NSCLC whose tumors have PD-L1 expression (tumor cell ≥1%), and who lack actionable driver mutations such as EGFR, ALK, or ROS1. Patients must have measurable disease per RECIST 1.1 criteria and adequate organ function. Prior treatment for advanced/metastatic disease, previous anti-PD-1, anti-PD-L1, or anti-TIGIT therapy are not allowed. Patients with symptomatic brain metastases or active autoimmune disorders are excluded.

Design: This is a randomized, double-blind, multicenter, global phase III trial. Patients are assigned to two treatment arms in a 1:1 ratio, comparing an experimental therapy to a standard active comparator. Treatment continues until disease progression or unacceptable toxicity, with endpoints assessed over up to 5 years.

Treatments: Patients receive either rilvegostomig or pembrolizumab, both in combination with platinum-based doublet chemotherapy consisting of cisplatin or carboplatin plus pemetrexed; maintenance therapy consists of the checkpoint inhibitor combined with pemetrexed. Rilvegostomig is a bispecific IgG1 monoclonal antibody that targets PD-1 and TIGIT, both immune checkpoint receptors involved in T cell suppression. Early-phase studies have shown rilvegostomig to be well-tolerated, with a favorable safety profile and initial evidence of anti-tumor activity in heavily pretreated NSCLC patients. Pembrolizumab is a standard-of-care anti-PD-1 checkpoint inhibitor for PD-L1 positive NSCLC.

Outcomes: The primary endpoints are overall survival (OS) and progression-free survival (PFS) by RECIST 1.1. Secondary endpoints include landmark OS and PFS rates, time to second progression, overall response rate, duration of response, pharmacokinetics, immunogenicity, patient-reported physical functioning, global health status/quality of life, and lung cancer symptom deterioration. All outcomes are assessed over a period of up to 5 years.

Burden on patient: The burden on patients is moderate and comparable to other phase III, first-line NSCLC trials. Standard requirements include tumor biopsy for PD-L1 testing, regular imaging (CT or MRI) according to RECIST 1.1, and periodic laboratory assessments for organ function. Patients randomized to the rilvegostomig arm may undergo additional blood draws for pharmacokinetic and immunogenicity analysis. Patient-reported outcome questionnaires will be administered throughout the study. All chemotherapy and immunotherapy are given intravenously per standard schedules, and the frequency of clinic visits is similar to standard of care regimens. Overall, the burden is increased slightly by the investigational procedures but remains within commonly accepted standards for first-line oncology trials.

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Hangzhou, 310016, China

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Budapest, 1083, Hungary

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Gyöngyös, 3200, Hungary

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Ota-shi, 373-8550, Japan

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Yokohama-shi, 241-8515, Japan

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Sunto-gun, 411-8777, Japan

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Shinjuku-ku, 160-0023, Japan

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Sendai-shi, 981-0914, Japan

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Amagasaki-shi, 660-8550, Japan

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Chuo-ku, 104-0045, Japan

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Hiroshima-shi, 734-8551, Japan

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Kobe-shi, 650-0017, Japan

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Kitakyushu-shi, 807-8555, Japan

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Seoul, 06351, Korea, Republic of

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Gyeonggi-do, 13620, Korea, Republic of

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Kuching, 93586, Malaysia

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Petaling Jaya, 47500, Malaysia

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Groningen, 9713 GZ, Netherlands

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Lima, 15102, Peru

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Łódź, 93-338, Poland

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Biała Podlaska, 21-500, Poland

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Bydgoszcz, 85-796, Poland

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Barcelona, 8035, Spain

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Dusit, 10300, Thailand

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Nakhon Ratchasima, 30000, Thailand

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Ankara, 06010, Turkey

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Edirne, 22030, Turkey

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London, SE1 9RT, United Kingdom

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London, EC1A 7BE, United Kingdom

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Exeter, EX2 5DW, United Kingdom

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Edinburgh, EH4 2XU, United Kingdom

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Cambridge, CB2 0QQ, United Kingdom

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Aberdeen, AB25 2ZN, United Kingdom

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Torquay, TQ2 7AA, United Kingdom

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Mobile, Alabama, 36608, United States

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Chandler, Arizona, 85224, United States

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Phoenix, Arizona, 85054, 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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Anaheim, California, 92801, United States

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Beverly Hills, California, 90211, United States

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San Francisco, California, 94121, United States

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Santa Rosa, California, 95403, United States

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Walnut Creek, California, 94598, United States

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San Diego, California, 92123, United States

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Lone Tree, Colorado, 80124, United States

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Stamford, Connecticut, 06902, United States

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West Haven, Connecticut, 06516, United States

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Newark, Delaware, 19713, United States

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Gainesville, Florida, 32610, United States

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Bay Pines, Florida, 33744, United States

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Jacksonville, Florida, 32224, United States

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Fort Lauderdale, Florida, 33308, United States

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Saint 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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Atlanta, Georgia, 30342, United States

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Boise, Idaho, 83712, United States

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Rockford, Illinois, 61114, United States

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Chicago, Illinois, 60637, United States

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Decatur, Illinois, 62526, United States

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Hinsdale, Illinois, 60521, United States

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Quincy, Illinois, 62305, United States

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Waterloo, Iowa, 50702, 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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Shreveport, Louisiana, 71105, United States

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Alexandria, Louisiana, 71301, United States

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Research Site

Baton Rouge, Louisiana, 70808, United States

No email / No phone

Status: Not yet recruiting

Research Site

Shreveport, Louisiana, 71103, United States

No email / No phone

Status: Not yet recruiting

Research Site

South Portland, Maine, 04106, United States

No email / No phone

Status: Not yet recruiting

Research Site

Baltimore, Maryland, 21202, United States

No email / No phone

Status: Recruiting

Research Site

Grand Rapids, Michigan, 49503, United States

No email / No phone

Status: Recruiting

Research Site

Saint Paul, Minnesota, 55102, United States

No email / No phone

Status: Recruiting

Research Site

Duluth, Minnesota, 55805, United States

No email / No phone

Status: Withdrawn

Research Site

Rochester, Minnesota, 55905, United States

No email / No phone

Status: Recruiting

Research Site

Bridgeton, Missouri, 63044, United States

No email / No phone

Status: Recruiting

Research Site

Columbia, Missouri, 65212, United States

No email / No phone

Status: Withdrawn

Research Site

Lincoln, Nebraska, 68506, United States

No email / No phone

Status: Recruiting

Research Site

Camden, New Jersey, 08103, United States

No email / No phone

Status: Not yet recruiting

Research Site

Westbury, New York, 11590, United States

No email / No phone

Status: Recruiting

Research Site

Buffalo, New York, 14221, United States

No email / No phone

Status: Not yet recruiting

Research Site

Canton, Ohio, 44710, United States

No email / No phone

Status: Recruiting

Research Site

Medford, Oregon, 97504, United States

No email / No phone

Status: Not yet recruiting

Research Site

Portland, Oregon, 97239, United States

No email / No phone

Status: Withdrawn

Research Site

Salem, Oregon, 97301, United States

No email / No phone

Status: Recruiting

Research Site

Pittsburgh, Pennsylvania, 15212, United States

No email / No phone

Status: SUSPENDED

Research Site

York, Pennsylvania, 17403, United States

No email / No phone

Status: Recruiting

Research Site

Providence, Rhode Island, 02903, United States

No email / No phone

Status: Withdrawn

Research Site

Pierre, South Dakota, 57501, United States

No email / No phone

Status: Recruiting

Research Site

Sioux Falls, South Dakota, 57105, United States

No email / No phone

Status: Recruiting

Research Site

Chattanooga, Tennessee, 37404, United States

No email / No phone

Status: Recruiting

Research Site

Nashville, Tennessee, 37203, United States

No email / No phone

Status: Recruiting

Research Site

Kingwood, Texas, 77339, United States

No email / No phone

Status: Recruiting

Research Site

Palestine, Texas, 75801, United States

No email / No phone

Status: Recruiting

Research Site

Round Rock, Texas, 78665, United States

No email / No phone

Status: Not yet recruiting

Research Site

Fort Worth, Texas, 76104, United States

No email / No phone

Status: Recruiting

Research Site

Houston, Texas, 77090, United States

No email / No phone

Status: SUSPENDED

Research Site

Lubbock, Texas, 79410, United States

No email / No phone

Status: Withdrawn

Research Site

Roanoke, Virginia, 24014, United States

No email / No phone

Status: Recruiting

Research Site

Norfolk, Virginia, 23502, United States

No email / No phone

Status: Recruiting

Research Site

Fairfax, Virginia, 22031, United States

No email / No phone

Status: Recruiting

Research Site

Wenatchee, Washington, 98801, United States

No email / No phone

Status: Withdrawn

Research Site

Tacoma, Washington, 98405, United States

No email / No phone

Status: Recruiting

Research Site

Spokane, Washington, 99208, United States

No email / No phone

Status: Not yet recruiting

Research Site

Silverdale, Washington, 98383, United States

No email / No phone

Status: Recruiting

Research Site

Seattle, Washington, 98104, United States

No email / No phone

Status: Withdrawn

Research Site

Seattle, Washington, 98101, United States

No email / No phone

Status: Not yet recruiting

Research Site

La Crosse, Wisconsin, 54601, United States

No email / No phone

Status: Withdrawn

Research Site

Hanoi, 100000, Vietnam

No email / No phone

Status: Recruiting

Research Site

Ho Chi Minh, 700000, Vietnam

No email / No phone

Status: Recruiting

Research Site

Vinh, 460000, Vietnam

No email / No phone

Status: Recruiting

Research Site

Can Tho, 900000, Vietnam

No email / No phone

Status: Recruiting

Research Site

Ho Chi Minh City, 700000, Vietnam

No email / No phone

Status: Recruiting

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