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: Determine whether first-line rilvegostomig plus platinum-based chemotherapy improves efficacy compared with pembrolizumab plus the same chemotherapy in PD-L1–positive metastatic non-squamous NSCLC, while assessing safety.

Patients: Patients with untreated stage IV non-squamous NSCLC, tumor PD-L1 expression in at least 1% of tumor cells, measurable disease, and adequate organ function. Patients with sensitizing EGFR mutations, ALK or ROS1 rearrangements, or other actionable drivers with locally approved first-line targeted therapies are excluded. Stable, asymptomatic brain metastases are permitted under specified conditions.

Design: Global, multicenter, randomized, double-blind, two-arm trial comparing two first-line chemoimmunotherapy regimens. Follow-up for key outcomes extends to approximately five years.

Treatments: Both groups receive pemetrexed plus cisplatin or carboplatin, combined with either rilvegostomig or pembrolizumab; maintenance consists of pemetrexed with the assigned immunotherapy. Rilvegostomig is an investigational bispecific antibody targeting PD-1 and TIGIT to counter inhibitory immune signaling. In a preliminary single-arm study of checkpoint-inhibitor–naïve advanced NSCLC, reported response rates were 29.0% for PD-L1 expression of 1–49% and 61.8% for expression of at least 50%; these results do not establish comparative benefit. Pembrolizumab is an established PD-1 inhibitor used with platinum–pemetrexed chemotherapy in this setting.

Outcomes: Primary endpoints are overall survival and RECIST 1.1 progression-free survival. Secondary measures include landmark survival rates, time to second progression or death, response rate and duration, rilvegostomig pharmacokinetics and immunogenicity, and patient-reported physical function, quality of life, and lung cancer symptoms.

Burden on patient: Estimated moderate burden. Both arms involve recurring intravenous chemoimmunotherapy and maintenance visits, imaging to assess disease, and routine safety monitoring, broadly consistent with intensive standard first-line treatment. Trial-specific requirements include a suitable tumor sample, blood sampling for drug concentrations and antidrug antibodies, and patient questionnaires; multicenter visits may also require travel. The schedule and whether a new biopsy is necessary are not specified.

Last updated: Sep 2026

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Can Tho, 900000, Vietnam

No email / No phone

Status: Recruiting

Research Site

Ho Chi Minh City, 700000, Vietnam

No email / No phone

Status: Recruiting

Research Site

Jinan, 250117, China

No email / No phone

Status: Active, not recruiting

Research Site

Changsha, 410013, China

No email / No phone

Status: Not yet recruiting

Research Site

Shanghai, 200433, China

No email / No phone

Status: Not yet recruiting

Research Site

München, 81925, Germany

No email / No phone

Status: Not yet recruiting

Research Site

Budapest, 1083, Hungary

No email / No phone

Status: Not yet recruiting

Research Site

Mumbai, 400012, India

No email / No phone

Status: Not yet recruiting

Research Site

Kyoto, 612-8555, Japan

No email / No phone

Status: Not yet recruiting

Research Site

Warsaw, 04-141, Poland

No email / No phone

Status: Not yet recruiting

Research Site

Loma Linda, California, 92350, United States

No email / No phone

Status: Not yet recruiting

Research Site

Ocala, Florida, 34474, United States

No email / No phone

Status: Not yet recruiting

Research Site

Baton Rouge, Louisiana, 70808, 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

La Plata, 1900, Argentina

No email / No phone

Status: Withdrawn

Research Site

Sint-Niklaas, 9100, Belgium

No email / No phone

Status: Withdrawn

Research Site

São Paulo, 01246-000, Brazil

No email / No phone

Status: Withdrawn

Research Site

Taubaté, 12030-200, Brazil

No email / No phone

Status: Withdrawn

Research Site

Sydney, Nova Scotia, B1P 1P3, Canada

No email / No phone

Status: Withdrawn

Research Site

Gyöngyös, 3200, Hungary

No email / No phone

Status: Withdrawn

Research Site

Székesfehérvár, 8000, Hungary

No email / No phone

Status: Withdrawn

Research Site

New Delhi, 110075, India

No email / No phone

Status: Withdrawn

Research Site

Kolkata, 700054, India

No email / No phone

Status: Withdrawn

Research Site

Groningen, 9713 GZ, Netherlands

No email / No phone

Status: Withdrawn

Research Site

Lima, LIMA 29, Peru

No email / No phone

Status: Withdrawn

Research Site

Lima, 15036, Peru

No email / No phone

Status: Withdrawn

Research Site

Lima, Lima 34, Peru

No email / No phone

Status: Withdrawn

Research Site

Lima, 15102, Peru

No email / No phone

Status: Withdrawn

Research Site

Bialystok, 15-027, Poland

No email / No phone

Status: Withdrawn

Research Site

Exeter, EX2 5DW, United Kingdom

No email / No phone

Status: Withdrawn

Research Site

Chandler, Arizona, 85224, United States

No email / No phone

Status: Withdrawn

Research Site

Gainesville, Florida, 32610, United States

No email / No phone

Status: Withdrawn

Research Site

Atlanta, Georgia, 30342, United States

No email / No phone

Status: Withdrawn

Research Site

Rockford, Illinois, 61114, United States

No email / No phone

Status: Withdrawn

Research Site

Lexington, Kentucky, 40536, United States

No email / No phone

Status: Withdrawn

Research Site

Alexandria, Louisiana, 71301, United States

No email / No phone

Status: Withdrawn

Research Site

Duluth, Minnesota, 55805, United States

No email / No phone

Status: Withdrawn

Research Site

Columbia, Missouri, 65212, United States

No email / No phone

Status: Withdrawn

Research Site

Portland, Oregon, 97239, United States

No email / No phone

Status: Withdrawn

Research Site

Pittsburgh, Pennsylvania, 15212, United States

No email / No phone

Status: Withdrawn

Research Site

Providence, Rhode Island, 02903, United States

No email / No phone

Status: Withdrawn

Research Site

Lubbock, Texas, 79410, United States

No email / No phone

Status: Withdrawn

Research Site

Houston, Texas, 77090, United States

No email / No phone

Status: Withdrawn

Research Site

Seattle, Washington, 98104, United States

No email / No phone

Status: Withdrawn

Research Site

Wenatchee, Washington, 98801, United States

No email / No phone

Status: Withdrawn

Research Site

La Crosse, Wisconsin, 54601, United States

No email / No phone

Status: Withdrawn

Research Site

Bydgoszcz, 85-796, Poland

No email / No phone

Status: SUSPENDED

Research Site

Biała Podlaska, 21-500, Poland

No email / No phone

Status: SUSPENDED

Research Site

San Juan, 00918, Puerto Rico

No email / No phone

Status: SUSPENDED

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