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RecruitingLast updated: 6 October 2023

TRAIN: This phase III study is evaluating whether targeted therapy (telisotuzumab vedotin) is more effective than chemotherapy (docetaxel) in people with non-small cell lung cancerA Phase 3 Open-Label, Randomized, Controlled, Global Study of Telisotuzumab Vedotin (ABBV-399) Versus Docetaxel in Subjects With Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer

Clinical summary

Summary

Eligible participants will be randomly allocated to either the Experimental Arm or the Active Comparator Arm. In the Experimental Arm, participants will receive telisotuzumab vedotin every 2 weeks via intravenous (IV) infusion. In the Active Comparator Arm, participants will receive docetaxel every 3 weeks via IV infusion.

Conditions

This trial is treating patients with c-MET overexpressing advanced or metastatic non-small cell lung cancer

Cancer

Lung Cancers Lung cancer

Age

People18+

Phase

III

Trial Acronym

TRAIN

More information

Trial Identifiers

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Trial sponsor

AbbVie

Scientific Title

A Phase 3 Open-Label, Randomized, Controlled, Global Study of Telisotuzumab Vedotin (ABBV-399) Versus Docetaxel in Subjects With Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer

Eligibility

Inclusion

  • Participants must have c-Met overexpressing non-small cell lung cancer (NSCLC) as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory using the VENTANA MET (SP44) RxDx assay.
  • Archival or fresh tumor material must be submitted for assessment of c-Met levels during the Pre-Screening period. Tumor material from the primary tumor site and/or metastatic sites are allowed.

    • If a participant was prescreened for Study M14-239 but did not enroll, tumor material previously submitted for Study M14-239 may be used for Study M18-868 Pre-Screening upon confirmation from AbbVie that sufficient evaluable tumor material is available (Except China).
  • A histologically documented non-squamous cell NSCLC that is locally advanced or metastatic.
  • A known epidermal growth factor receptor (EGFR) activating mutation status.
  • Actionable alterations in genes other than EGFR .
  • Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
  • An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
  • Have received no more than 1 line of prior systemic cytotoxic chemotherapy in the locally advanced or metastatic setting.

    • Neoadjuvant and adjuvant systemic cytotoxic chemotherapy will count as a prior line for eligibility purposes if progression occurred within 6 months of the end of therapy.
  • Have progressed on at least 1 line of prior therapy for locally advanced/metastatic NSCLC:

    • Participants WITHOUT an actionable gene alteration: must have progressed on (or be considered ineligible for) platinum-based chemotherapy and immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy).
    • Participants WITH an actionable gene alteration for which immune checkpoint inhibitor therapy is not standard of care (e.g., anaplastic lymphoma kinase [ALK] translocation): must have progressed on (or be considered ineligible for) anti-cancer therapy targeting driver gene alterations and platinum-based chemotherapy.

      • Participants with actionable gene alterations for which immune checkpoint inhibitor is standard of care must have also progressed on (or be considered ineligible for) immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy).
  • Must be considered appropriate for docetaxel therapy based on the assessment of the treating physician.
  • Participants with metastases to the central nervous system (CNS) are eligible only after definitive therapy (such as surgery or radiotherapy) is provided and:

    • There is no evidence of progression of CNS metastases at least 2 weeks after definitive therapy.
    • They are asymptomatic and off or on a stable or reducing dose of systemic steroids and/or anticonvulsants for at least 2 weeks prior to first dose of telisotuzumab vedotin.

Exclusion

  • Participants with adenosquamous histology.
  • Actionable epidermal growth factor receptor (EGFR) activating mutations.
  • Participants who have received prior c-Met-targeted antibodies, prior telisotuzumab vedotin, or prior antibody-drug conjugates either targeting c-Met or consisting of monomethylauristatin E..
  • Participants who have received prior docetaxel therapy.
  • A history of other malignancies except:

    • Malignancy treated with curative intent and with no known active disease present for >=2 years before the first dose of study drug and felt to be at low risk for recurrence by investigator.
    • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
    • Adequately treated carcinoma in situ without current evidence of disease.
  • 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. A history of prior radiation pneumonitis in the radiation field (fibrosis) is permitted.
  • Unresolved adverse event (AE) >= Grade 2 from prior anticancer therapy, except for alopecia or anemia.
  • Major surgery within 21 days prior to the first dose of telisotuzumab vedotin.
  • Clinically significant condition(s) as listed in the protocol.

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • 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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