Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Durvalumab and Carboplatin for First-Line Treatment of Patients With Advanced NSCLC Without Actionable Genomic Alterations

Overview

About this study

The purpose of this study is to compare the effectiveness and safety of Datopotamab Deruxtecan (Dato-DXd) in combination with durvalumab and carboplatin compared with pembrolizumab in combination with histology-specific platinum-based chemotherapy as first-line treatment of adults with stage IIIB, IIIC, or IV NSCLC without actionable genomic alterations (including sensitizing EGFR mutations, and ALK and ROS1 rearrangements).

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:

- Participants ≥ 18 years at screening

- Participants with histologically or cytologically documented NSCLC that is Stage IIIB
or IIIC disease not amenable for surgical resection or definitive chemoradiation or
Stage IV metastatic NSCLC disease at the time of randomisation, who have not received
prior chemotherapy or other systemic therapy for first-line Stage IIIB, IIIC or IV

- Lacks sensitising EGFR tumour tissue mutation and ALK and ROS1 rearrangements and has
no documented tumour genomic alterations in NTRK, BRAF, RET, MET or other actionable
driver oncogenes with approved therapies (actionable genomic alterations).

- ECOG PS of 0 or 1

- Archival tumour tissue collected prior to signing of ICF

- Has adequate bone marrow reserve and organ function within 7 days before randomisation

Exclusion:

- History of another primary malignancy except for malignancy treated with curative
intent with no known active disease within 3 years before the first dose of study
intervention and of low potential risk for recurrence

- Mixed small-cell lung cancer and NSCLC histology; sarcomatoid variant of NSCLC

- Persistent toxicities caused by previous anti-cancer therapy not yet improved to Grade
≤ 1 or baseline (with exceptions)

- Active or prior documented autoimmune, connective tissue or inflammatory disorders
(with exceptions)

- Spinal cord compression or brain metastases unless asymptomatic, stable, not requiring
steroids for at least 7 days prior to randomisation, and a minimum of 2 weeks have
elapsed between the end of radiotherapy and study enrollment

- History of leptomeningeal carcinomatosis

- Clinically significant corneal disease

- Known active or uncontrolled hepatitis B or C virus infection

- Known HIV infection that is not well controlled

- 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

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 2/01/2024. Questions regarding updates should be directed to the study team contact.

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

Anastasios Dimou, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Yanyan Lou, M.D., Ph.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Vinicius Ernani, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available