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
- Research Site · Mobile, AL 36608More trials in Mobile
AZ
- Research Site · Chandler, AZ 85224More trials in Chandler
- Research Site · Phoenix, AZ 85054More trials in Phoenix
CA
- Research Site · Anaheim, CA 92801More trials in Anaheim
- Research Site · Beverly Hills, CA 90211More trials in Beverly Hills
- Research Site · Loma Linda, CA 92350More trials in Loma Linda
- Research Site · Redlands, CA 92373More trials in Redlands
- Research Site · San Diego, CA 92123More trials in San Diego
- Research Site · San Francisco, CA 94121More trials in San Francisco
- Research Site · Santa Rosa, CA 95403More trials in Santa Rosa
- Research Site · Walnut Creek, CA 94598More trials in Walnut Creek
CO
- Research Site · Lone Tree, CO 80124More trials in Lone Tree
CT
- Research Site · Stamford, CT 06902More trials in Stamford
- 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 32610More trials in Gainesville
- Research Site · Jacksonville, FL 32224More trials in Jacksonville
- Research Site · Miami, FL 33125More trials in Miami
- Research Site · Ocala, FL 34474More trials in Ocala
- Research Site · St. Petersburg, FL 33709More trials in St. Petersburg
GA
- Research Site · Atlanta, GA 30342More trials in Atlanta
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 62305More trials in Quincy
- Research Site · Rockford, IL 61114More trials in Rockford
KY
- Research Site · Lexington, KY 40509More trials in Lexington
- Research Site · Lexington, KY 40536More trials in Lexington
- 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 · 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 20889More trials in Bethesda
ME
- Research Site · South Portland, ME 04106More trials in South Portland
MI
- Research Site · Grand Rapids, MI 49503More trials in Grand Rapids
MN
- Research Site · Duluth, MN 55805More trials in Duluth
- Research Site · Rochester, MN 55905More trials in Rochester
- Research Site · Saint Paul, MN 55102More trials in Saint Paul
MO
- Research Site · Bridgeton, MO 63044More trials in Bridgeton
- Research Site · Columbia, MO 65212More trials in Columbia
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 · Westbury, NY 11590More trials in Westbury
OH
- Research Site · Canton, OH 44710More trials in Canton
OR
- Research Site · Medford, OR 97504More trials in Medford
- Research Site · Portland, OR 97239More trials in Portland
- Research Site · Salem, OR 97301More trials in Salem
PA
- Research Site · Pittsburgh, PA 15212More trials in Pittsburgh
- Research Site · York, PA 17403More trials in York
RI
- Research Site · Providence, RI 02903More trials in Providence
SD
- Research Site · Pierre, SD 57501More trials in Pierre
- 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 · Irving, TX 75063More trials in Irving
- Research Site · Kingwood, TX 77339More trials in Kingwood
- Research Site · Lubbock, TX 79410More trials in Lubbock
- Research Site · Palestine, TX 75801More trials in Palestine
- Research Site · Round Rock, TX 78665More trials in Round Rock
VA
- Research Site · Fairfax, VA 22031More trials in Fairfax
- Research Site · Norfolk, VA 23502More trials in Norfolk
- Research Site · Roanoke, VA 24014More trials in Roanoke
WA
- Research Site · Seattle, WA 98101More trials in Seattle
- Research Site · Seattle, WA 98104More 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
WI
- Research Site · La Crosse, WI 54601More trials in La Crosse