Current Clinical Trials

S1900J:Targeted Treatment for Advanced Non-Small Cell Lung Cancer That Has Increased Copies of the MET Gene (An Expanded Lung-MAP Treatment Trial)
  1. Delshad Ahmad, MD
    Delshad Ahmad, MD
  2. for people 18 Years and up (full criteria)
  3. Rancho Mirage, CA
  4. study started April 2025
  5. Delshad Ahmad, MD
  6. Accepting new patients

Description

Summary

This phase II Expanded Lung-MAP treatment trial tests how well amivantamab-subcutaneous (SC) works in treating patients patients with MET amplification non-small cell lung cancer. Amivantamab-SC is a drug that reduces extra copies of the MET gene, a change present in your tumor. Giving amivantamab-SC may lower the chance of the growth or spread of advanced non-small cell lung cancer that has extra copies of the MET gene in the tumor.

Official Title

A Phase II Study of Amivantamab SC (Subcutaneous) in Participants with MET Amplification-Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (LUNG-MAP SUB-STUDY)

Detailed Description

PRIMARY OBJECTIVE:I. To evaluate the objective response rate (ORR) (confirmed and unconfirmed, complete and partial) in participants with MET amplification-positive non-small cell lung cancer (NSCLC) treated with amivantamab-SC within each cohort.SECONDARY OBJECTIVES:I. To evaluate progression-free survival (PFS) within each cohort. II. To evaluate overall survival (OS) within each cohort. III. To evaluate the duration of response among responders within each cohort. IV. To evaluate the frequenc... more
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PRIMARY OBJECTIVE:I. To evaluate the objective response rate (ORR) (confirmed and unconfirmed, complete and partial) in participants with MET amplification-positive non-small cell lung cancer (NSCLC) treated with amivantamab-SC within each cohort.SECONDARY OBJECTIVES:I. To evaluate progression-free survival (PFS) within each cohort. II. To evaluate overall survival (OS) within each cohort. III. To evaluate the duration of response among responders within each cohort. IV. To evaluate the frequency and severity of toxicities within each cohort and combined across all study participants.TRANSLATIONAL MEDICINE OBJECTIVES:I. To collect, process, and bank cell-free deoxyribonucleic acid (cfDNA) prior to treatment on Cycle 1 Day 1, Cycle 3 Day 1, and at first progression for future development of a proposal to evaluate comprehensive next-generation sequencing of circulating tumor deoxyribonucleic acid (ctDNA).II. To establish a tissue/blood repository from participants with refractory non-small cell lung cancer (NSCLC).OUTLINE:Patients receive amivantamab subcutaneously (SC) on days 1, 8, 15, and 22 of cycle 1 and then on days 1 and 15 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo computerized tomography (CT) or magnetic resonance imaging (MRI) and collection of blood samples throughout the trial.After completion of study treatment, patients are followed up for up to 3 years.

Keywords

Lung Non-Small Cell Carcinoma

Eligibility

for people 18 Years and up
Inclusion Criteria:* Participants must have been assigned to S1900J by the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC). Assignment to S1900J is determined by the LUNGMAP protocol* Participants must have documentation of NSCLC with MET amplification determined by FMI tissue-based next generation sequencing (NGS) assay* Participants must have measurable disease documented by CT or MRI. The CT from a combined positron emission tomography (PET)/CT may be used to docu... more
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Inclusion Criteria:* Participants must have been assigned to S1900J by the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC). Assignment to S1900J is determined by the LUNGMAP protocol* Participants must have documentation of NSCLC with MET amplification determined by FMI tissue-based next generation sequencing (NGS) assay* Participants must have measurable disease documented by CT or MRI. The CT from a combined positron emission tomography (PET)/CT may be used to document measurable disease ONLY if it is of diagnostic quality: otherwise, it may be used to document non-measurable disease only. Measurable disease must be assessed within 28 days prior to sub-study registration. Pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease. Non-measurable disease must be assessed within 42 days prior to sub-study registration. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form. Participants whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to sub-study registration to be considered measurable* Participants must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to sub-study registration* Participants with asymptomatic CNS metastasis (brain metastases or leptomeningeal disease) must be clinically stable and asymptomatic for at least 14 days prior to sub-study registration * NOTE: Participants can be on a low-dose corticosteroid treatment (= 10 mg prednisone or equivalent) for at least 14 days prior to study treatment* Participants must not have other known actionable oncogenic alterations, such as (but not limited to) EGFR sensitizing mutations, EGFR T790M mutation, MET Exon-14 skipping mutant NSCLC, ALK gene fusion, ROS1 gene rearrangement, RET gene rearrangement, NTRK rearrangement, HER2 mutation, KRAS activating mutations, and BRAF V600E mutation* Participants must have progressed (in the opinion of the treating physician) following the most recent line of therapy* Participants must have received at least one line of systemic treatment for Stage IV or recurrent NSCLC* Participants must have recovered (= Grade 1) from any side effects of prior therapy. The exception is if a side effect from a prior treatment is known to be permanent without expected further recovery or resolution (i.e., endocrinopathy from immunotherapy or cisplatin neurotoxicity)* Participants must not have been previously treated for any cancer with MET tyrosine kinase inhibitors (TKIs) such as tepotinib, capmatinib, and crizotinib* Participants must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 21 days prior to sub-study registration* Participants must not have a prior treatment with anti-PD-1 or anti-PD-L1 antibody within 6 weeks of sub-study registration* Participants must not have received any radiation therapy within 14 days prior to sub-study registration* Participants must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment while receiving treatment on this study* Participants must not have had major surgery excluding placement of vascular access or tumor biopsy, or had significant traumatic injury within 28 days prior to sub-study registration, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study * NOTE: Participants with planned surgical procedures to be conducted under local anesthesia may participate* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen* Absolute neutrophil count = 1.5 x 10^3/uL (within 28 days prior to sub-study registration)* Hemoglobin >= 10.0 g/dL (within 28 days prior to sub-study registration)* Platelets = 75 x 10^3/uL (within 28 days prior to sub-study registration)* Total bilirubin = 1.5 x institutional upper limit of normal (ULN) unless history of Gilbert’s disease. Participants with history of Gilbert’s disease must have total bilirubin = 5 x institutional ULN (within 28 days prior to sub-study registration)* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 3 × institutional ULN. Participants with history of liver metastasis must have AST and ALT = 5 x ULN (within 28 days prior to sub-study registration)* Participants must have a serum creatinine = the institutional upper limit of normal (IULN) or calculated creatinine clearance = 45 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to sub-study registration. For creatinine clearance formula see the tools on the CRA Workbench* Participants’ most recent Zubrod performance status must be 0-2 and be documented within 28 days prior to sub-study registration* Participants must have a completed medical history and physical exam within 28 days prior to sub-study registration* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better* Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy and have undetectable viral load test on the most recent test results obtained within 6 months prior to sub-study registration* Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to sub-study registration* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to sub-study registration* Participants with known diabetes as determined by the treating investigator must show evidence of controlled disease within 14 days prior to sub-study registration* Participants of reproductive potential must have a negative serum pregnancy test within 7 days prior to sub-study registration* Participants must not have other clinically active infectious liver disease* Participants must not have clinically significant hypertension within 28 days prior to sub-study registration as determined by the treating investigator* Participants must not have a history of pneumonitis that required drug therapy or an active symptomatic interstitial lung disease (ILD)/pneumonitis, including drug-induced or radiation ILD/pneumonitis* Participants must not have ongoing or active infection or be diagnosed or suspected viral infection as determined by the treating investigator. NOTE: Participants that have an infection requiring antimicrobial therapy will be required to complete antibiotics 1 week prior to starting treatment* Participants must not have active bleeding diathesis as determined by the treating investigator* Participants must not have impaired oxygenation requiring continuous oxygen supplementation as determined by the treating investigator* Participants must not have psychiatric illness, social situation, or any other circumstances that would limit compliance with study requirements as determined by the treating investigator* Participants must not have any ophthalmologic condition that is unstable in the opinion of the treating investigator* Participants must not be pregnant or breastfeeding (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen* Participants must agree to have blood specimens submitted for circulating tumor DNA (ctDNA)* Participants must also be offered participation in specimen banking. With participant consent, specimens must be collected and submitted via the SWOG Specimen Tracking System* Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines * NOTE: Participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations

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 April 2025
  3. INTERVENTIONAL
  4. May 08, 2025