RecruitingPhase 3

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

AR

AZ

CA

FL

GA

IL

IN

KY

MA

MD

MI

MO

MS

MT

NC

NE

NJ

NV

NY

OH

OR

SC

SD

TN

TX

VA

WA

WI