About the study

This study will assess safety, tolerability, and treatment activity of datopotamab deruxtecan (Dato-DXd) in combination with immunotherapy in participants with advanced or metastatic non-small cell lung cancer (NSCLC).

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

1. Participant ≥18 years old on the day of signing the ICF (local regulatory requirement to consent should be followed).
2. Histologically or cytologically confirmed diagnosis of advanced or metastatic NSCLC, without EGFR or ALK genomic alterations and no known genomic alterations in other actionable driver kinases with approved therapies
3. For Cohorts 1 to 4, participants must be treatment-naïve or have received and radiologically progressed after only 1 prior line of systemic chemotherapy, without concomitant immune checkpoint inhibitors for advanced or metastatic NSCLC. For Cohorts 5 to 11, participants must be treatment-naïve for advanced or metastatic NSCLC.
4. Willing and able to undergo a mandatory tumor biopsy
5. Has measurable disease per RECIST1.1 within 28 days prior to Cycle 1 Day 1
6. Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1 at screening
7. Has adequate bone marrow reserve and organ function at baseline within 7 days prior to Cycle 1 day 1
8. For Cohorts 5 to 11 only: Documented IHC PD-L1 expression per analytically validated Ventana PD-L1 (SP263) IHC assay, 22C3 PharmDx assay, or 28-8 PharmDx assay

Exclusion criteria

1. Active or prior documented autoimmune or inflammatory disorders
2. Uncontrolled or significant cardiac disease
3. History of another primary malignancy
4. active or uncontrolled hepatitis B or C virus or uncontrolled HIV infection
5. spinal cord compression or clinically active CNS metastases
6. History of (non-infectious) ILD/pneumonitis that required steroids
7. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illness
8. Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals
9. Clinically significant corneal disease

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.