Clinical Trials

Current Clinical Trials

A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin Compared to IV Docetaxel in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
  1. Delshad Ahmad, MD
    Delshad Ahmad, MD
  2. for people 18 Years and up (full criteria)
  3. Rancho Mirage, CA
  4. study started March 2022
  5. Delshad Ahmad, MD
  6. Accepting new patients

Description

Summary

The purpose of this study is to determine if telisotuzumab vedotin therapy is superior to docetaxel in subjects with c-Met overexpressing epidermal growth factor receptor (EGFR) wildtype, non-squamous, Non-Small Cell Lung Cancer (NSCLC) that has progressed after standard of care therapies.

Official Title

AbbVie M18-868 Phase 3 Randomized, Controlled 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

Keywords

Non Small Cell Lung Cancer

Eligibility

for people 18 Years and up
Inclusion Criteria: 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 previ... more
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Inclusion Criteria: 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 Criteria: 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.

Lead Scientists at Eisenhower Health

Delshad Ahmad, MD
Board Certified Medical Oncologist and Hematologist, Delshad Ahmad, MD, is dedicated to providing personalized cancer care for his patients and their families. He received his medical degree from Damascus University in Syria, where he also attended a residency program in internal medicine. Once in the United States, he completed a residency program in internal medicine at the Hurley Medical Center in Flint, Michigan. He then went on to complete a fellowship in Hematology/Oncology at Michigan Sta... more
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Board Certified Medical Oncologist and Hematologist, Delshad Ahmad, MD, is dedicated to providing personalized cancer care for his patients and their families. He received his medical degree from Damascus University in Syria, where he also attended a residency program in internal medicine. Once in the United States, he completed a residency program in internal medicine at the Hurley Medical Center in Flint, Michigan. He then went on to complete a fellowship in Hematology/Oncology at Michigan State University, East Lansing, Michigan. Currently, Dr. Ahmad is the Director of Thoracic Oncology at Eisenhower Lucy Curci Cancer Center (LCCC).

In his younger years, Dr. Ahmad excelled in sciences and coupled with his desire to help people and encouragement from his family he decided to pursue a medical degree while at university. During rotations in his residency program, he was drawn to the specialty of oncology (cancer) and hematology (blood diseases). “Oncology/Hematology offered me the greatest opportunity to positively affect patient’s lives,” states Dr. Ahmad. “It is a field that is in constant change, with new protocols and treatments always on the forefront of study. I am a constant learner and knew that this specialty of medicine would always challenge me.” The specialty of oncology/hematology was personal as well for Dr. Ahmad. While in medical school and residency, a close cousin was battling cancer and he became very involved with her treatment and care.

With regard to his approach to patient care, Dr. Ahmad strives to provide patients with all the options, possibilities and treatments with regard to treating their disease. “Every patient is unique and every treatment is unique,” states Dr. Ahmad. “I want to understand my patients' goals, provide them with the information they need to accomplish those and partner with them in developing their treatment plan. I am with them all along their journey toward health.”

Dr. Ahmad sees patients in Rancho Mirage, La Quinta and Yucca Valley.
 

Clinical Study Details

  1. Accepting new patients
  2. study started March 2022
  3. Interventional
  4. Expecting 698 study participants
  5. May 28, 2024