Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations
A Phase III, Randomised, Open-label, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Pembrolizumab Monotherapy for the First-line Treatment of Participants With Locally-advanced or Metastatic Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations (TROPION-Lung10)
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 Dato-DXd plus rilvegostomig, or rilvegostomig alone, works compared with pembrolizumab alone, and how safe they are. It is for people starting treatment for advanced non-squamous non-small cell lung cancer (NSCLC) with high levels of a protein called PD-L1 and without certain gene changes that can be treated with targeted drugs.
The purpose of this study is to evaluate efficacy and safety of Dato-DXd in combination with rilvegostomig or rilvegostomig monotherapy compared with pembrolizumab monotherapy as a first line therapy in participants with locally advanced or metastatic non-squamous NSCLC with high PD-L1 expression (TC ≥ 50%) and without actionable genomic alterations.
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 cured with surgery or treated with chemotherapy and radiation aimed at a cure.
- Have no qualifying EGFR, ALK, or ROS1 gene changes, and no local test showing other gene changes with locally approved, available targeted drugs for first treatment.
- Provide a tumor sample for tests of PD-L1, TROP2, and other markers.
- Have PD-L1 on at least 50% of tumor cells.
- Have at least one tumor area that can be measured under study rules and has not had radiation.
- Be fully active or able to do light work despite some limits on hard physical activity.
- Have enough healthy blood-forming cells and organs that work well enough.
Who can't join
- Have had drug treatment for advanced or spreading NSCLC, have certain other lung cancer types (squamous, mostly squamous, mixed small cell, or sarcomatoid), or had another cancer within 3 years.
- Have a current or past immune system or inflammatory disorder, with some exceptions; a history of an immune system weakness you were born with; or severe or uncontrolled disease that makes joining unsafe or following study rules difficult.
- Have a serious fluid buildup, such as around the lungs, that cannot be drained repeatedly, or major limits in lung function.
- Have past, current, or suspected lung tissue inflammation or scarring. Past inflammation from radiation is allowed if it did not need steroids.
- Have pressure on the spinal cord or cancer spread to the brain, unless treated, free of symptoms, stable on scans, and needing no steroids or seizure medicines; or ever had cancer spread to the lining around the brain and spinal cord.
- Have a significant disease of the cornea, the clear front part of the eye.
- Have active tuberculosis or hepatitis A, B, or C, or known HIV that is not well controlled.
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 IIIB or IIIC or Stage IV metastatic NSCLC (according to Edition 8 of the AJCC staging manual) not amenable to curative surgery or definitive chemoradiation. * Absence of sensitising EGFR mutations, and ALK and ROS1 rearrangements, and absence of documented local test result for any other known genomic alteration for which there are locally approved and available targeted first-line therapies. * Must provide tumor sample to determine PD-L1 status, TROP2 status and other biomarkers. * Known tumour PD-L1 expression status defined as TC ≥ 50% * At least one lesion, not previously irradiated that qualifies as a RECIST 1.1 target lesion at baseline * ECOG performance status of 0 or 1 * Adequate bone marrow reserve and organ function Exclusion Criteria: * Prior systemic therapy for advanced/metastatic NSCLC. * Squamous cell histology, or predominantly squamous cell histology NSCLC; mixed small cell lung cancer; NSCLC histology, sarcomatoid variant. * History of another primary malignancy within 3 years * Active or prior documented autoimmune or inflammatory disorders (with exceptions) * Any evidence of severe or uncontrolled disease that makes it undesirable for the participant to participate in the study or that would jeopardies compliance with the protocol. * Has clinically significant third-space fluid retention (for example pleural effusion) and is not amenable for repeated drainage. * History of any ILD/pneumonitis, including radiation pneumonitis (apart from radiation pneumonitis that did not require steroids), or drug-induced ILD/pneumonitis, has current or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening. * Has significant pulmonary function compromise, as determined by the investigator * Spinal cord compression, or brain metastases unless participant treated and no longer symptomatic, radiologically stable, and who require no treatment with corticosteroids or anticonvulsants. * History of leptomeningeal carcinomatosis * Known clinically significant corneal disease * Active infection with TB, HBV, HCV, Hepatitis A, or known HIV infection that is not well controlled * History of active primary immunodeficiency
Study sites (63)
AK
- Research Site · Anchorage, AK 99508More trials in Anchorage
AR
- Research Site · Little Rock, AR 72205More trials in Little Rock
- Research Site · Springdale, AR 72762More trials in Springdale
AZ
- Research Site · Tucson, AZ 85719More trials in Tucson
CA
- Research Site · Anaheim, CA 92801More trials in Anaheim
- Research Site · Beverly Hills, CA 90211More trials in Beverly Hills
- Research Site · Fountain Valley, CA 92708More trials in Fountain Valley
- Research Site · Newport Beach, CA 92663More trials in Newport Beach
FL
- Research Site · Clermont, FL 34711More trials in Clermont
- Research Site · Gainesville, FL 32608More trials in Gainesville
- Research Site · Miami Beach, FL 33140More trials in Miami Beach
- Research Site · Orange City, FL 32763More trials in Orange City
- Research Site · Orlando, FL 32806More trials in Orlando
- Research Site · Orlando, FL 32827More trials in Orlando
- Research Site · West Palm Beach, FL 33401More trials in West Palm Beach
GA
- Research Site · Atlanta, GA 30303More trials in Atlanta
- Research Site · Atlanta, GA 30318More trials in Atlanta
- Research Site · Atlanta, GA 30322More trials in Atlanta
- Research Site · Atlanta, GA 30342More trials in Atlanta
IL
- Research Site · Hinsdale, IL 60521More trials in Hinsdale
IN
- Research Site · Noblesville, IN 46062More trials in Noblesville
KY
- Research Site · Paducah, KY 42003More trials in Paducah
MA
- Research Site · Boston, MA 02114More trials in Boston
- Research Site · Boston, MA 02215More trials in Boston
MD
- Research Site · Annapolis, MD 21401More trials in Annapolis
MI
- Research Site · Dearborn, MI 48126More trials in Dearborn
- Research Site · Farmington Hills, MI 48334More trials in Farmington Hills
- Research Site · Grand Rapids, MI 49503More trials in Grand Rapids
- Research Site · Traverse City, MI 49684More trials in Traverse City
MO
- Research Site · Kansas City, MO 64132More trials in Kansas City
MS
- Research Site · Hattiesburg, MS 39401More trials in Hattiesburg
MT
- Research Site · Bozeman, MT 59715More trials in Bozeman
NC
- Research Site · Greenville, NC 27834More trials in Greenville
- Research Site · Salisbury, NC 28144More trials in Salisbury
NE
- Research Site · Grand Island, NE 68803More trials in Grand Island
- Research Site · Omaha, NE 68130More trials in Omaha
NJ
- Research Site · Voorhees Township, NJ 08043More trials in Voorhees Township
NV
- Research Site · Las Vegas, NV 89102More trials in Las Vegas
- Research Site · Reno, NV 89502More trials in Reno
NY
- Research Site · Stony Brook, NY 11794More trials in Stony Brook
OH
- Research Site · Cincinnati, OH 45219More trials in Cincinnati
- Research Site · Columbus, OH 43210More trials in Columbus
- Research Site · Maumee, OH 43537More trials in Maumee
- Research Site · Toledo, OH 43623More trials in Toledo
OR
- Research Site · Portland, OR 97213More trials in Portland
SC
- Research Site · Greenville, SC 29607More trials in Greenville
SD
- Research Site · Sioux Falls, SD 57105More trials in Sioux Falls
TN
- Research Site · Chattanooga, TN 37404More trials in Chattanooga
- Research Site · Knoxville, TN 37920More trials in Knoxville
TX
- Research Site · Fort Worth, TX 76104More trials in Fort Worth
- Research Site · Houston, TX 77030More trials in Houston
- Research Site · Houston, TX 77030More trials in Houston
- Research Site · Houston, TX 77090More trials in Houston
- Research Site · Kingwood, TX 77339More trials in Kingwood
- Research Site · Odessa, TX 79761More trials in Odessa
VA
- Research Site · Fort Belvoir, VA 22060More trials in Fort Belvoir
- Research Site · Leesburg, VA 20176More trials in Leesburg
- Research Site · Midlothian, VA 23114More trials in Midlothian
- Research Site · Richmond, VA 23230More trials in Richmond
WA
- Research Site · Tacoma, WA 98405More trials in Tacoma
- Research Site · Vancouver, WA 98684More trials in Vancouver
- Research Site · Wenatchee, WA 98801More trials in Wenatchee
WI
- Research Site · Appleton, WI 54911More trials in Appleton