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RecruitingLast updated: 2 February 2024

M22-137: This study is evaluating the effectiveness of a new cancer drug (telisotuzumab vedotin) in people with previously untreated MET amplified non-squamous cell non-small cell lung cancerPhase 2, Open-Label Study in Subjects With Previously Untreated MET Amplified Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

Clinical summary

Summary

Eligible participants will receive telisotuzumab vedotin via intravenous infusion (IV) every two weeks.

Conditions

This trial is treating patients with MET amplified non-squamous cell non-small cell lung cancer

Cancer

Lung Cancers Lung cancer

Age

People18+

Phase

II

Trial Acronym

M22-137

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

AbbVie

Scientific Title

Phase 2, Open-Label Study in Subjects With Previously Untreated MET Amplified Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

Eligibility

Inclusion

  • Must have MET amplification in tumor tissue as determined by the Sponsor-designated central laboratory MET FISH Assay or in plasma and/or tissue by a Sponsor-approved assay.
  • Must have histologically documented non-squamous adenocarcinoma non-small cell lung cancer (NSCLC) that is locally advanced or metastatic.
  • Must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
  • Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Participant may have received prior adjuvant/neoadjuvant systemic chemotherapy and/or radiation and/or immunotherapy provided that the subject has not progressed on or within 6 months of completing the regimen and it was completed >= 6 months before subject's first dose of study drug.
  • Metastases to the central nervous system (CNS) are eligible only after definitive therapy is provided as noted in the protocol.
  • History of radiation pneumonitis in the radiation field (fibrosis) is permitted.

Exclusion

  • Alterations in EGFR, ALK, ROS1, or BRAF that predict sensitivity to available targeted therapy. Participants with other alterations that are candidates for available targeted therapy.
  • Prior systemic therapy for locally advanced/metastatic NSCLC. Of note, limited treatment with no more than 1 cycle of chemotherapy is allowed prior to receiving the first dose of study drug provided there is no evidence of progression.
  • Have a history of other malignancies except those noted in the protocol.
  • Have a history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan.
  • Received prior c-Met-targeted antibodies.
  • Have NSCLC that is eligible for treatment with curative intent.
  • Have unresolved adverse events (AEs) >= Grade 2 from prior anticancer therapy, except for alopecia or anemia.
  • Have had major surgery within 21 days prior to the first dose of telisotuzumab vedotin.
  • Have clinically significant condition(s) as noted in the protocol.

Inclusion

  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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