Clinical Trial 23772

• Overview

  Study Title:

  A Phase 2/3 Open Label Randomized Study of Telisotuzumab Adizutecan Compared to Standard of Care in Subjects with Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non- Small Cell Lung Cancer After Progression on a Third-Generation EGFR TKI - AndroMETa-Lung-713

  Summary:

  Non-small cell lung cancer (NSCLC) is a common type of lung cancer where abnormal cells in the lungs grow out of control. The purpose of this study is to assess adverse events and change in disease activity of telisotuzumab adizutecan compared to standard of care (SOC). Telisotuzumab adizutecan is an investigational drug being developed for the treatment of NSCLC. This study will be divided into two stages, in the first stage (phase 2) participants will receive 1 of 2 doses of telisotuzumab adizutecan. In the second stage (phase 3) participants will receive the recommended phase 3 dose (RP3D) of telisotuzumab adizutecan, from the previous stage, or SOC. Approximately 430 adult participants with NSCLC will be enrolled in the study in 200 sites around the world. In phase 2, participants will receive 1 of 2 intravenous (IV) doses of telisotuzumab adizutecan. In phase 3, participants will receive the IV RP3D of telisotuzumab adizutecan, or SOC. The study will run for a duration of approximately 69 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

  Objective:

  Primary Objectives Phase 2: *To evaluate the safety and tolerability of telisotuzumab adizutecan. *To evaluate the efficacy of telisotuzumab adizutecan as measured by OR per BICR. *To select the RP3D of telisotuzumab adizutecan. Phase 3: *To evaluate the efficacy of telisotuzumab adizutecan compared with standard of care based on PFS per BICR assessment. Secondary Objectives Phase 2: *To further evaluate the efficacy of telisotuzumab adizutecan as measured by PFS, DoR, and DCR per BICR,and OS. *To characterize the PK and immunogenicity of telisotuzumab adizutecan. Phase 3: *To evaluate the efficacy of telisotuzumab adizutecan compared with standard of care based on OS. *To evaluate the efficacy of telisotuzumab adizutecan compared with standard of care as measured by OR, DoR, and DCR per BICR assessment. *To evaluate the safety and tolerability of telisotuzumab adizutecan compared with standard of care. *To evaluate the impact of telisotuzumab adizutecan on patient-reported lung cancer symptoms as measured by the EORTC QLQ-LC13. *To evaluate the impact of telisotuzumab adizutecan on patient-reported physical functioning and quality of life (QoL) as measured by EORTC QLQ-C30.

• Treatments

  Therapies:

  Antibody-Drug Conjugate

  Medications:

  Telisotuzumab Adizutecan ()

• Inclusion Criteria

  Key Inclusion Criteria:
  • Histologically or cytologically confirmed diagnosis of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with documented EGFR Exon 19 deletion or Exon21 L858R mutation.
  • Provide archived or recently obtained tumor tissue during Screening.
  • Received one prior third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) therapy in the adjuvant, locally advanced, or metastatic setting, either as monotherapy or in combination with other agents, and experienced documented radiographic disease progression on or after therapy for the most recent regimen administered prior to study entry.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
  • At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, that has not been previously irradiated.
  • Central nervous system (CNS) metastasis, these should be clinically asymptomatic or stable after definitive treatment.
  • Current, historical, or suspected interstitial lung disease (ILD)/pneumonitis that required steroids should be excluded.
  • If the prior third-generation EGFR TKI was administered in the adjuvant setting, progression must have occurred while on treatment.

• Exclusion Criteria

  Key Exclusion Criteria:
  • Tumor(s) have adenosquamous or squamous histology or sarcomatoid features.
  • Received more than 1 line of systemic therapy in the locally advanced or metastatic setting.
  • Have any clinically significant medical conditions or any other reason that the investigator determines would interfere with the participant's participation.

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