A Randomized, Open-label, Phase 3 Trial of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in Treatment-naïve Subjects with Advanced or Metastatic PD-L1 High (TPS =50%) Non-small Cell Lung Cancer Without Actionable Genomic Alterations (Tropion-Lung08)

Daiichi Sankyo, Inc.0 sites740 target enrollmentMarch 22, 2022

DrugsKEYTRUDA

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Daiichi Sankyo, Inc.
Enrollment: 740
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 22, 2022

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Daiichi Sankyo, Inc.

Eligibility Criteria

Inclusion Criteria

•Subjects must meet all of the following criteria to be eligible for randomization into the study:
•1\. Sign and date the Tissue Screening and Main ICFs, prior to the start of any study\-specific qualification procedures.
•2\. Adults \=18 years or the minimum legal adult age (whichever is greater) at the time of informed consent. (Follow local regulatory requirements if the legal age of adult voluntary consent for study participation is \>18 years old.)
•3\. Histologically documented NSCLC that meets all of the following criteria:
•a. Stage IIIB or IIIC disease and not candidates for surgical resection or definitive chemoradiation, or Stage IV NSCLC disease at the time of randomization (based on the American Joint Committee on Cancer, Eighth Edition).
•b. Documented negative test results for EGFR, ALK, and ROS1 actionable genomic alterations based on analysis of tumor tissue. If test results for EGFR, ALK, and ROS1 are not available, subjects are required to undergo testing performed locally for these genomic alterations.
•c. No known actionable genomic alterations in NTRK, BRAF, RET, MET, or other actionable driver kinases with locally approved therapies. (Testing for genomic alterations besides EGFR, ALK, and ROS1 is not required prior to enrollment.) Subjects with squamous NSCLC are only required to
•undergo EGFR, ALK, and ROS1 testing if they have no history of tobacco
•smoking or were diagnosed with NSCLC at \<40 years of age. Subjects
•whose tumors harbor KRAS mutations are eligible for the study.

Exclusion Criteria

•Subjects who meet any of the following criteria will be disqualified from entering the study:
•1\. Has received prior systemic treatment for advanced or metastatic NSCLC.
•2\. Has received prior treatment with any of the following, including in the adjuvant/neoadjuvant setting:
•a. Any agent, including an antibody\-drug conjugate, containing a chemotherapeutic agent targeting topoisomerase I.
•b. TROP2\-targeted therapy.
•c. Any anti\-programmed death receptor\-1 (PD\-1\), anti\-PD\-L1, or anti\-PD\-ligand 2 (L2\) agent or with an agent directed to another stimulatory or co\-inhibitory T\-cell receptor (eg, CTLA\-4, OX40, CD137\).
•d. Any other immune checkpoint inhibitors.
•Subjects who received adjuvant or neoadjuvant therapy OTHER than those listed above, are eligible if the adjuvant/neoadjuvant therapy was completed at least 6 months prior to the diagnosis of advanced/metastatic disease.
•3\. Has spinal cord compression or active and untreated central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are radiologically stable (ie, without evidence of progression) for at least 4 weeks by repeat imaging (note: repeat imaging should be performed during study screening), clinically stable, and without requirement of steroid treatment for at least 7 days before the first dose of study drug. Note: A computed tomography (CT) scan or magnetic resonance imaging (MRI) scan of the brain at baseline (MRI preferred) is required for all subjects. For those subjects in whom CNS metastases are first discovered at the time of screening, the treating investigator should consider delay of study treatment to document stability of CNS metastases with repeat imaging at least 4 weeks later (in which case, repeat of all screening activity may be required).
•4\. Has received prior radiotherapy \=4 weeks of start of study intervention or more than 30 Gy to the lung within 6 months of Cycle 1 Day 1\. Subjects must have recovered from all radiationrelated toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 2\-week washout is permitted for palliative radiation (\=2 weeks of radiotherapy) to non\-CNS disease.