A Phase III, Randomised Study Of Adjuvant Dato-DXd In Combination With Rilvegostomig Or Rilvegostomig Monotherapy Versus Standard Of Care, Following Complete Tumour Resection, In Participants With Stage I Adenocarcinoma NSCLC Who Are CtDNA-positive Or Have High-risk Pathological Features

Overview

About this study

This is a Phase III, randomised, open-label, multicentre, global study assessing the efficacy and safety of adjuvant Dato-DXd in combination with rilvegostomig compared with SoC, after complete surgical resection (R0) in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive, as determined by the Sponsor-designated ctDNA assay, or have at least one high-risk pathological feature.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria: 1. Histologically documented treatment-naive Stage I (T \< 4 cm, AJCC 8th ed) adenocarcinoma NSCLC 2. Complete surgical resection (R0) of the primary NSCLC 3. Unequivocal no evidence of disease at post-surgical 4. Pre-surgical ctDNA-positive result (Stage IA or IB) OR presence of at least one high-risk pathological feature (visceral pleural invasion (VPI), lymphovascular invasion (LVI), high-grade histology) (Stage IB only) 5. ECOG of 0 or 1, life expectancy of \> 6 months and complete recovery after surgery 6. Adequate bone marrow reserve and organ function Exclusion Criteria: 1. Sensitizing EGFR mutation and/or ALK alteration 2. History of non-infectious ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening 3. Significant pulmonary function compromise 4. History of another primary malignancy within 3 years (with exceptions) 5. Any evidence of severe or uncontrolled systemic diseases, including but not limited to bleeding diseases, active infection and cardiac disease 6. Active or prior documented autoimmune or inflammatory disorders (with exceptions) 7. Active infection with tuberculosis, hepatitis B or C virus, hepatitis A, or known HIV infection that is not well controlled 8. History of active primary immunodeficiency 9. Clinically significant corneal disease

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Dennis Wigle, M.D., Ph.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Ian Makey, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Staci Beamer, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
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CLS-20588590

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