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Clinical Trial 21089

Cancer Type: Thoracic
Study Type: Treatment
NCT#: NCT04484142

Phase: Phase II
Principal Investigator: Shafique, Michael

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Overview

Study Title

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)

Summary

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.

Objective

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.

Treatments

Therapies

Immunotherapy

Medications

DS-1062a (); Not Applicable ()

Inclusion Criteria

  • 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, IIIC 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 EGFR, in the absence of activating mutations, is NOT sufficient for enrollment
  • Participants who have not received osimertinib should be evaluated for the presence of EGFR T790M mutation after relapse/progression on/after the most recent EGFR TKI, unless the patient is already known to be positive with documented results for this mutation or unless osimertinib is not locally approved.
  • Has documentation of radiographic disease progression while on or after receiving the most recent treatment regimen for advanced or metastatic NSCLC.
  • Participant must meet the following for advanced or metastatic NSCLC:
  • Has been treated with at least one but no more than two cytotoxic agent-containing therapy in the metastatic setting: one platinum containing regiment (either as monotherapy or combination therapy); may have received up to one additional line of cytotoxic agent-containing therapy; Those who received a platinum-containing regimen as adjuvant therapy for early stage disease must have relapsed or progressed while on treatment or within 6 months of the last dose OR received at least one additional course of platinum-containing therapy (which may or may not be same as in the adjuvant setting) for relapsed/progressive disease;
  • May have received up to one checkpoint inhibitor (CPI) containing regimen (may be in combination with a cytotoxic agent as part of a regimen described above or as an additional CPI regimen without a cytotoxic agent);
  • Has been treated with one or more lines of non-CPI targeted therapy that is locally approved for the patient's applicable genomic alteration at the time of screening; OR one of more of the agents specified in the protocol.
  • Has progressed on or after at least one kinase inhibitor as specified in the study protocol
  • 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.
  • Additional criteria apply

  • Exclusion Criteria

  • 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 chemotherapeutic agent targeting topoisomerase I, including ADC containing such therapy.
  • TROP2-targeted therapy.
  • Uncontrolled or significant cardiovascular disease:
  • Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) >470 milliseconds (based on the average of screening triplicate 12-lead ECG determinations)
  • 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.
  • LVEF > Uncontrolled hypertension (resting systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg).
  • 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.
  • Other criteria apply

  • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.