RecruitingPhase 3

A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer (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 Squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung02)

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 tests how well rilvegostomig plus platinum-based chemotherapy works and how safe it is, compared with pembrolizumab plus chemotherapy. It is for people starting treatment for advanced squamous non-small cell lung cancer, a type of lung cancer, whose tumors have a protein called PD-L1.

The purpose of ARTEMIDE-Lung02 is to assess the efficacy and safety of rilvegostomig in combination with platinum-based chemotherapy for the first-line (1L) treatment of patients with locally advanced or metastatic squamous non-small cell lung cancer (mNSCLC) whose tumors express programmed death-ligand 1 (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

  • A tissue or cell test confirms squamous non-small cell lung cancer.
  • The cancer is stage IIIB, IIIC, or IV and cannot be treated with the goal of a cure.
  • Routine local tests have not found a tumor gene change with an approved, available targeted drug for first treatment.
  • You can provide a suitable tumor sample showing PD-L1 protein on at least 1% of tumor cells.
  • At least one tumor area has not had radiation and can be measured repeatedly by CT or MRI. It must be at least 10 mm across, or 15 mm across its shorter side if it is a lymph node.
  • Your organs and bone marrow, which makes blood cells, work well enough.

Who can't join

  • The cancer includes small cell or neuroendocrine cancer cells.
  • Cancer has spread to the brain, unless it is stable, causes no symptoms, and needs no steroids or seizure medicines for at least 7 days before study group assignment. Any brain radiation or surgery must have ended at least 2 weeks earlier, and you must have recovered from its short-term side effects.
  • You have had whole-body treatment for this lung cancer that was not meant to cure it.
  • You have had anti-PD-1, anti-PD-L1, anti-TIGIT, or other cancer treatment aimed at immune-system controls.
  • You have had another cancer, unless it was treated with the goal of a cure, has shown no active disease for at least 2 years before the first study dose, and has a low risk of returning.
  • You have or had an autoimmune disease, where the immune system attacks the body, or an inflammatory disease needing ongoing whole-body treatment with disease-modifying or immune-suppressing drugs.
  • You have an active immune deficiency, meaning a condition that weakens your 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 squamous NSCLC. * Stage III B/C or IV mNSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative treatment. * Absence of documented tumor genomic mutation results from tests conducted as part of standard local practice in any 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, non-curative therapy received for NSCLC. * Any prior treatment with an anti-PD-1 or anti-PD-L1 agent. * Any prior exposure to an anti-TIGIT therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms. * 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 or other immunosuppressive drugs. * Active primary immunodeficiency/active infectious disease(s). * Active tuberculosis infection.

Study sites (77)

AR

AZ

CA

CT

DE

FL

GA

IA

ID

IL

IN

KY

LA

MD

ME

MI

MN

MO

NC

ND

NE

NJ

NY

OH

OR

PA

SD

TN

TX

VA

WA