Phase 2, Single-arm, Open-label Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer with Actionable Genomic Alterations and Progressed On or After Kinase Inhibitor Therapy and Platinum-based Chemotherapy (TROPION-Lung05)
This is a study of the efficacy, pharmacokinetics, and safety of DS-1062a in participants with advanced or metastatic non-small cell lung cancer (NSCLC) with known actionable genomic alterations.
To assess the efficacy of DS-1062a, as measured by the ORR, as a treatment for subjects with NSCLC with actionable genomic alterations that has progressed on or after 1 or more kinase inhibitors and platinum-based chemotherapy. To further evaluate the efficacy, safety, PK and immunogenicity of DS-1062a.
Sign and date the inform consent form (ICF) prior to the start of any study- specific qualification procedures.
Adults > 18 years (if the legal age of consent is >18 years old, then follow local regulatory requirements)
Has pathologically documented NSCLC that:
Has stage IIIB or stage IV NSCLC disease at the time of enrollment
Has one or more of the following documented activating genomic alterations: EGFR, ALK, ROS1, NTRK, BRAF, MET exon 14 skipping, or RET.
Overexpression of any of the above, in the absence of activating mutations, is NOT sufficient for enrollment
Participants with EGFR genomic alterations should be evaluated for the presence of EGFR T790M mutation after relapse/progression on/after the most recent anti-EGFR TKI, unless already known to carry this mutation. Participants with EGFR mutations (regardless of T790M status) should comprise no less than 40% and no more than 50% of participants by the conclusion of study enrollment.
Has documentation of radiographic disease progression while on or after receiving the most recent treatment regimen for advanced or metastatic NSCLC.
Participant must meet at least the following for advanced or metastatic NSCLC:
Has progressed on or after at least one kinase inhibitor as specified in the study protocol
Has progressed on or after at least 1 regimen of platinum-based chemotherapy
Up to 4 prior lines of therapy are allowed to be eligible for this study
Willing and able to undergo a mandatory pre-treatment tumor biopsy
Measurable disease based on local imaging assessment using RECIST v1.1.
Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 - 1 at screening.
Participants meeting any exclusion criteria for this study will be excluded from this study.
Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Participants with clinically inactive brain metastases may be included in the study.
Has leptomeningeal carcinomatosis.
Has prior treatment with:
Any agent including antibody drug conjugate (ADC) containing a chemotherapeutic agent targeting topoisomerase I.
Uncontrolled or significant cardiovascular disease:
History of myocardial infarction within 6 months prior to Cycle 1 Day 1.
History of uncontrolled angina pectoris within 6 months prior to Cycle 1 Day 1.
Symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV) at screening. Participants with a history of Class II to IV CHF prior to screening must have returned to Class I CHF and have LVEF > 50% (by either an ECHO or MUGA scan within 28 days of Cycle 1 Day 1) in order to be eligible.
History of serious cardiac arrhythmia requiring treatment.
Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
Clinically significant corneal disease.
Has other primary malignancies, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated, with no evidence of disease for > 3 years.
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