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Clinical Trials in India / NCT06627647
Recruiting Phase 3

A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Locally Advanced or Metastatic Non-Squamous NSCLC

NCT06627647 · tracked via the Priya Life Science India tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2024-11-27
Last updated
2026-08-14

Condition(s) studied

Non-squamous Non-small Cell Lung Cancer

Investigational drug(s) / intervention(s)

RilvegostomigPembrolizumabCarboplatinCisplatinPemetrexed

Rilvegostomig: Administered as one intravenously (IV) on Day 1 of each 21-day cycle

Pembrolizumab: Administered as one intravenously (IV) on Day 1 of each 21-day cycle

Carboplatin: Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles

Cisplatin: Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles

Pemetrexed: Administered as one intravenously (IV) on Day 1 of each 21-day cycle

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
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.

Primary outcome measure(s)

Trial sites (295)

FacilityCityRegionStatus
Research Site Mobile Alabama Recruiting
Research Site Chandler Arizona Withdrawn
Research Site Phoenix Arizona Recruiting
Research Site Anaheim California Recruiting
Research Site Beverly Hills California Recruiting
Research Site Loma Linda California Recruiting
Research Site Redlands California Recruiting
Research Site San Diego California Recruiting
Research Site San Francisco California Recruiting
Research Site Santa Rosa California Recruiting
Research Site Walnut Creek California Recruiting
Research Site Lone Tree Colorado Recruiting
Research Site Stamford Connecticut Recruiting
Research Site West Haven Connecticut Recruiting
Research Site Newark Delaware Recruiting
Research Site Bay Pines Florida Recruiting
Research Site Fort Lauderdale Florida Recruiting
Research Site Gainesville Florida Withdrawn
Research Site Jacksonville Florida Recruiting
Research Site Miami Florida Recruiting
Research Site Ocala Florida Recruiting
Research Site St. Petersburg Florida Recruiting
Research Site Atlanta Georgia Withdrawn
Research Site Boise Idaho Recruiting
Research Site Chicago Illinois Recruiting
Research Site Decatur Illinois Recruiting
Research Site Hinsdale Illinois Recruiting
Research Site Quincy Illinois Recruiting
Research Site Rockford Illinois Withdrawn
Research Site Waterloo Iowa Recruiting
Research Site Lexington Kentucky Recruiting
Research Site Lexington Kentucky Withdrawn
Research Site Louisville Kentucky Recruiting
Research Site Alexandria Louisiana Withdrawn
Research Site Baton Rouge Louisiana Recruiting
Research Site Shreveport Louisiana Recruiting
Research Site Shreveport Louisiana Recruiting
Research Site South Portland Maine Recruiting
Research Site Baltimore Maryland Recruiting
Research Site Grand Rapids Michigan Recruiting

+ 255 more sites — see the full list on the official registry below.

On this site

📄 Keytruda (pembrolizumab) drug profile →

More AstraZeneca trials in India

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06627647 on ClinicalTrials.gov ↗ ← All trials in India