RecruitingPhase 3

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares rilvegostomig with pembrolizumab, each given with two chemotherapy drugs, including a platinum drug. It tests how well they work and how safe they are as a first treatment for advanced non-squamous non-small cell lung cancer (NSCLC). It is for people whose cancer has the PD-L1 protein.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have non-squamous NSCLC confirmed by a tissue or cell test.
  • Have stage IIIB, IIIC, or IV cancer that cannot be treated with the goal of a cure.
  • Have no specified EGFR gene changes or ALK or ROS1 gene changes.
  • Have no other known cancer gene changes found in routine local testing that have an approved, available targeted first treatment.
  • Provide a suitable tumor sample showing PD-L1 protein on at least 1% of tumor cells.
  • Have at least one tumor area that has not had radiation and can be measured repeatedly on CT or MRI scans. It must be at least 10 mm across, or 15 mm across its shorter side for a lymph node.
  • Have organs and bone marrow that work well enough. Bone marrow makes blood cells.

Who can't join

  • The cancer includes small cell or neuroendocrine cancer cells.
  • Have cancer that spread to the brain, unless it is stable, causes no symptoms, and needs no steroids or seizure drugs for at least 7 days before study group assignment. Any brain radiation or surgery must have ended at least 2 weeks earlier, and short-term side effects must have cleared.
  • Have had lung cancer treatment that works throughout the body, unless it was given around surgery or with radiation to try to cure the cancer, and the cancer worsened more than 12 months after treatment ended.
  • Have had anti-TIGIT treatment or another cancer treatment aimed at immune-control signals.
  • Have had anti-PD-1 or anti-PD-L1 treatment.
  • Have had another cancer, unless it was treated to cure it, had no known active disease for at least 2 years before the first study dose, and has a low chance of returning.
  • Have or have had an autoimmune or inflammatory disease needing long-term medicine that acts throughout the body. Autoimmune disease is when the immune system attacks the body.
  • Have an active primary immune deficiency, meaning a condition that weakens immune defenses, or an active infection, including tuberculosis.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (78)

AL

AZ

CA

CO

CT

DE

FL

GA

IA

ID

IL

KY

LA

MD

ME

MI

MN

MO

NE

NJ

NY

OH

OR

PA

RI

SD

TN

TX

VA

WA

WI