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RecruitingPhase 2 / Phase 3

A Study to Assess Adverse Events and Change in Disease Activity of Intravenous (IV) Telisotuzumab Adizutecan, Monotherapy or in Combination With Osimertinib, Compared to Standard of Care in Adult Participants With Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer

A Phase 2/3 Open Label Randomized Study of Telisotuzumab Adizutecan, Monotherapy or in Combination With Osimertinib, 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests an experimental drug, telisotuzumab adizutecan, given through a vein, alone or with osimertinib, and compares it with standard care. Researchers will check side effects and changes in the cancer. It is for adults with non-squamous non-small cell lung cancer that has spread nearby or to other parts of the body and has certain EGFR gene changes.

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 as a monotherapy or in combination with osimertinib 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 as a monotherapy or in combination with osimertinib. 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 490 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 as a monotherapy or in combination with oral osimertinib. 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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have lung cancer confirmed by a tissue or cell test, with an EGFR Exon 19 deletion or Exon 21 L858R gene change.
  • Provide a recent tumor sample for c-Met protein testing. A stored sample is also allowed.
  • Have received one prior treatment with a third-generation EGFR blocker, alone or with other drugs. Scans must show the cancer grew or spread during or after the most recent treatment.
  • If the prior EGFR blocker was given after surgery, the cancer must have grown or spread while taking it.
  • Be fully active or able to do light work, with limits only on hard physical activity.
  • Have at least one tumor that can be measured and has not been treated with radiation.

Who can't join

  • Have tumors with squamous, adenosquamous, or sarcomatoid features—certain cancer cell types seen under a microscope.
  • Have had more than one course of drug treatment for cancer that has spread nearby or to other parts of the body.
  • Have active cancer spread to the brain or spinal cord, or symptoms from that spread. Previously treated brain tumors may be allowed if scans show they are stable.
  • Have active lung inflammation, or have had lung inflammation that needed steroid treatment.
  • Have a serious health condition or another issue that the study doctor believes would interfere with taking part.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 recently obtained tumor tissue during Screening for c-Met immunohistochemistry (IHC) testing (and study stratification in Phase 2). If recently obtained tumor tissue is not available, archived tumor tissue is also acceptable. * 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. Participant who has received prior third-generation EGFR TKI therapy in the adjuvant setting must have progressed while on treatment. * 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. 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. * Active/symptomatic central nervous system (CNS) metastases. Previously treated brain metastases may be included provided they are radiologically stable. * Evidence of active interstitial lung disease (ILD)/pneumonitis or history of ILD or pneumonitis that required steroids. * Have any clinically significant medical conditions or any other reason that the investigator determines would interfere with the participant's participation.

Study sites (16)

AR

CA

FL

IN

MN

NE

NH

NJ

TN

WA