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
- Research Site · Springdale, AR 72762More trials in Springdale
AZ
- Research Site · Tucson, AZ 85724More trials in Tucson
CA
- Research Site · Anaheim, CA 92801More trials in Anaheim
- Research Site · Beverly Hills, CA 90211More trials in Beverly Hills
- Research Site · Loma Linda, CA 92354More trials in Loma Linda
- Research Site · Los Alamitos, CA 90720More trials in Los Alamitos
- Research Site · Redlands, CA 92373More trials in Redlands
- Research Site · San Francisco, CA 94121More trials in San Francisco
- Research Site · Walnut Creek, CA 94598More trials in Walnut Creek
CT
- Research Site · West Haven, CT 06516More trials in West Haven
DE
- Research Site · Newark, DE 19713More trials in Newark
FL
- Research Site · Bay Pines, FL 33744More trials in Bay Pines
- Research Site · Fort Lauderdale, FL 33308More trials in Fort Lauderdale
- Research Site · Gainesville, FL 32608More trials in Gainesville
- Research Site · Gainesville, FL 32610More trials in Gainesville
- Research Site · Jacksonville, FL 32224More trials in Jacksonville
GA
- Research Site · Athens, GA 30607More trials in Athens
- Research Site · Atlanta, GA 30341More trials in Atlanta
- Research Site · Savannah, GA 31404More trials in Savannah
IA
- Research Site · Waterloo, IA 50702More trials in Waterloo
ID
- Research Site · Boise, ID 83712More trials in Boise
IL
- Research Site · Chicago, IL 60637More trials in Chicago
- Research Site · Decatur, IL 62526More trials in Decatur
- Research Site · Hinsdale, IL 60521More trials in Hinsdale
- Research Site · Quincy, IL 62301More trials in Quincy
- Research Site · Rockford, IL 61114More trials in Rockford
IN
- Research Site · Fort Wayne, IN 46845More trials in Fort Wayne
KY
- Research Site · Lexington, KY 40509More trials in Lexington
- Research Site · Lexington, KY 40536More trials in Lexington
- Research Site · Louisville, KY 40202More trials in Louisville
- Research Site · Louisville, KY 40207More trials in Louisville
LA
- Research Site · Alexandria, LA 71301More trials in Alexandria
- Research Site · Baton Rouge, LA 70808More trials in Baton Rouge
- Research Site · Covington, LA 70433More trials in Covington
- Research Site · Shreveport, LA 71103More trials in Shreveport
- Research Site · Shreveport, LA 71105More trials in Shreveport
MD
- Research Site · Baltimore, MD 21202More trials in Baltimore
- Research Site · Bethesda, MD 20817More trials in Bethesda
- Research Site · Bethesda, MD 20889More trials in Bethesda
ME
- Research Site · Scarborough, ME 04074More trials in Scarborough
MI
- Research Site · Detroit, MI 48202More trials in Detroit
- Research Site · Grand Rapids, MI 49503More trials in Grand Rapids
- Research Site · Saginaw, MI 48602More trials in Saginaw
MN
- Research Site · Duluth, MN 55802More trials in Duluth
- Research Site · Rochester, MN 55905More trials in Rochester
MO
- Research Site · Bridgeton, MO 63044More trials in Bridgeton
- Research Site · Columbia, MO 65212More trials in Columbia
- Research Site · Kansas City, MO 64108More trials in Kansas City
NC
- Research Site · Wilson, NC 27893More trials in Wilson
ND
- Research Site · Grand Forks, ND 58201More trials in Grand Forks
NE
- Research Site · Lincoln, NE 68506More trials in Lincoln
NJ
- Research Site · Camden, NJ 08103More trials in Camden
NY
- Research Site · Buffalo, NY 14221More trials in Buffalo
- Research Site · East Syracuse, NY 13057More trials in East Syracuse
- Research Site · Westbury, NY 11590More trials in Westbury
OH
- Research Site · Cincinnati, OH 45267More trials in Cincinnati
OR
- Research Site · Bend, OR 97701More trials in Bend
- Research Site · Medford, OR 97504More trials in Medford
- Research Site · Salem, OR 97301More trials in Salem
PA
- Research Site · Hershey, PA 17033More trials in Hershey
- Research Site · York, PA 17403More trials in York
SD
- Research Site · Sioux Falls, SD 57105More trials in Sioux Falls
TN
- Research Site · Chattanooga, TN 37404More trials in Chattanooga
- Research Site · Nashville, TN 37203More trials in Nashville
TX
- Research Site · Fort Worth, TX 76104More trials in Fort Worth
- Research Site · Houston, TX 77090More trials in Houston
- Research Site · Kingwood, TX 77339More trials in Kingwood
- Research Site · Lubbock, TX 79410More trials in Lubbock
- Research Site · Round Rock, TX 78665More trials in Round Rock
VA
- Research Site · Fairfax, VA 22031More trials in Fairfax
- Research Site · Fredericksburg, VA 22408More trials in Fredericksburg
WA
- Research Site · Olympia, WA 98506More trials in Olympia
- Research Site · Seattle, WA 98101More trials in Seattle
- Research Site · Silverdale, WA 98383More trials in Silverdale
- Research Site · Spokane, WA 99208More trials in Spokane
- Research Site · Tacoma, WA 98405More trials in Tacoma
- Research Site · Wenatchee, WA 98801More trials in Wenatchee