Search Results Within Category "Lung Disease & Asthma"
6results
Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments (PROPHETIC)
clinicaltrials@northshore.org
All
18 years and over
NCT04056247
Inclusion Criteria:
• Cancer patients with stage IV NSCLC or stage IV malignant melanoma
• Patient must have at least one measurable lesion and the relevant images in order to enable assessment of response
• ECOG PS - 0/1-2
• Normal hematologic, renal and liver function:
• Absolute neutrophil count higher than 1500/mm3
• Platelets count higher than 100,000/mm3
• haemoglobin higher than 9 g/dL
• Creatinine concentration ≤1.4 mg/dL, or creatinine clearance higher than 40 mL/min
• Total bilirubin lower than 1.5 mg/dL, ALT and AST levels ≤ 3 times above the upper normal limit.
Exclusion Criteria:
• Concurrent and/or other active malignancy that has required systemic treatment within 2 years of first dose of study drug
• Generalized impairment or mental incompetence that would render the patient unable to understand his/her participation in the study.
Other: Plasma sample collection
Stage IV Non-small Cell Lung Cancer, Stage IV Malignant Melanoma, Stage IV Small Cell Lung Cancer, Stage III Malignant Melanoma
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)
clinicaltrials@northshore.org
ALL
18 years and over
PHASE3
NCT04928846
Inclusion Criteria:
* Projected life expectancy of at least 12 weeks.
* 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 or cytologically 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 adequate treatment (such as surgery, radiotherapy, or drug therapy) is provided and:
* They are asymptomatic and off or on a stable or reducing dose of systemic steroids (on no more than 10 mg per day \[QD\] prednisone or equivalent) and/or anticonvulsants for at least 2 weeks prior to randomization.
Exclusion Criteria:
* Evidence of new, untreated CNS metastases.
* Evidence of leptomeningeal disease.
* Participants with adenosquamous or neuroendocrine histology, nor sarcomatoid features.
* 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 or neuroendocrine histology, nor sarcomatoid features adverse event (AE) \>= Grade 2 from prior anticancer therapy, except for alopecia or anemia. Participants with hormone deficiencies caused by prior anticancer therapy who are asymptomatic and on a stable dose of replacement hormone are eligible for study.
* Major surgery within 21 days prior to randomization.
* Clinically significant condition(s) as listed in the protocol. BIOLOGICAL: Telisotuzumab Vedotin, DRUG: Docetaxel
Non Small Cell Lung Cancer
c-Met Overexpressing Non-Small Cell Lung Cancer, c-Met NSCLC, Telisotuzumab Vedotin, ABBV-399, Docetaxel, Cancer, Non Small Cell Lung Cancer, NSCLC, TeliMET NSCLC-01, Teliso-V
Study Assessing the Long-term Effect of Dupilumab on Prevention of Lung Function Decline in Adult Patients With Uncontrolled Moderate to Severe Asthma (ATLAS)
clinicaltrials@northshore.org
ALL
18 years and over
PHASE4
NCT05097287
Inclusion Criteria:
* Participant must be at least 18 (or the legal age of consent in the jurisdiction in which the study is taking place) years of age inclusive, at the time of signing the informed consent.
* Patients with a physician diagnosis of asthma (according to Global Initiative for Asthma (GINA) 2021) for ≥12 months
* Treatment with medium to high dose inhaled corticosteroids (ICS) in combination with a second controller (eg, long-acting beta-2 adrenergic receptor agonists (LABA), leukotriene receptor antagonists (LTRA) with a stable dose ≥1 month prior to Visit 1. Patients requiring a third controller for their asthma will be considered eligible for this study, and it should also be on stable dose ≥1 month prior to Visit 1. Patients requiring an additional controller as a fourth controller (Montelukast) for another type 2 comorbid condition such as allergic rhinitis will be considered eligible for this study, and should be on a stable dose for ≥1 month prior to Visit 1.
* Pre-bronchodilator forced expiratory volume (FEV1) ≤ 80% of predicted normal for adults at Visits 1 and 2, prior to randomization
* Asthma Control Questionnaire 5-question version (ACQ-5) score ≥1.5 at Visits 1 and 2, prior to randomization.
* Variable airflow obstruction as documented by one or more of the following (at least 1 needs to be met):
i) Positive reversibility test: ≥12% and 200 mL improvement in FEV1 after SABA administration prior to randomization, or documented in the 24 months prior to Visit 1. OR, ii) Positive bronchial challenge test: fall in FEV1 of ≥20% with standard doses of methacholine, or ≥15% with standardized hyperventilation, hypertonic saline or mannitol challenge prior to randomization or documented in the 24 months prior to Visit 1 OR, iii) Average daily diurnal Peak flow variability of \>10% over a 2-week period, documented in the past 24 months prior to Screening Visit 1. OR, iv) Airflow variability in clinic FEV1 \>12% and 200 mL between visits outside of respiratory infections, documented in the past 24 months prior to Screening Visit 1. OR v) FEV1 increases by more than 12% and 200mL from baseline after 4 weeks of anti-inflammatory treatment.
* Reversibility test: Three attempts may be made during the Screening Period until the Baseline visit to meet the qualifying criteria for reversibility. This is only required if reversibility or other evidence of expiratory airflow limitation eligibility criteria was not performed within 24 months prior to Visit 1.
* FeNO ≥35 ppb at Visit 2, prior to randomization.
* History of ≥1 severe exacerbation(s) in the previous year before Visit1 defined as a deterioration of asthma requiring:
i) Use of systemic corticosteroids for ≥3 days; or ii) Hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids.
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
* History or clinical evidence of chronic obstructive pulmonary disease (COPD) including Asthma-COPD Overlap Syndrome (ACOS) or any other significant lung disease (eg, emphysema, lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome).
* Severe asthma exacerbation requiring treatment with systemic corticosteroid (SCS) in the past month before visit 1 or during the screening period.
* Current acute bronchospasm or status asthmaticus.
* Diagnosed pulmonary (other than asthma) or systemic disease associated with elevated peripheral eosinophil counts.
* Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the participant's participation in the study. Examples include, but are not limited to, participants with short life expectancy, uncontrolled diabetes, cardiovascular conditions, severe renal conditions (eg, participants on dialysis), or other severe endocrinological, gastrointestinal, metabolic, pulmonary, psychiatric, or lymphatic diseases. The specific justification for participants excluded under this criterion will be noted in the study documents (chart notes, case report forms \[CRFs\], etc).
* Patients with active tuberculosis (TB) or non-tuberculous mycobacterial infection, or a history of incompletely treated TB will be excluded from the study unless it is well documented by a specialist that the participant has been adequately treated and can now start treatment with a biologic agent, in the medical judgment of the Investigator and/or infectious disease specialist. Tuberculosis testing will be performed on a country by country basis, according to local guidelines if required by regulatory authorities or ethics boards, or if TB is suspected by the investigator
* Known or suspected immunodeficiency, including history of invasive opportunistic infections (eg, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, and aspergillosis) despite infection resolution, or otherwise recurrent infections of abnormal frequency or prolonged duration suggesting an immune-compromised status, as judged by the Investigator.
* Active malignancy or history of malignancy within 5 years before Visit 1 (screening visit), except completely treated in situ carcinoma of the cervix and completely treated and resolved non metastatic squamous or basal cell carcinoma of the skin.
* Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antifungals or receiving only symptomatic treatment (e.g. influenza or COVID-19) within 2 weeks before the screening visit (Visit 1) or during the screening period.
* History of human immunodeficiency virus (HIV) infection or positive HIV 1/2 serology at Visit 1 (screening visit).
* Diagnosed with, suspected of, or at high risk of endoparasitic infection, and/or use of antiparasitic drugs within 2 weeks before Visit 1 (screening visit) or during the screening and run-in period
* Current smoker (cigarette or e-cigarette) or cessation of smoking within 6 months prior to Visit 1.
* Previous smoker with a smoking history \>10 pack-years.
* History of systemic hypersensitivity or anaphylaxis to dupilumab or any other biologic therapy, including any excipient.
* Any biologic therapy (including experimental treatments and dupilumab) or any other biologic therapy/immunosuppressant/immunomodulators within 4 weeks prior to V1 or 5 half-lives, whichever is longer.
* Treatment with a live (attenuated) vaccine within 4 weeks before Visit 1 (screening visit) or during the screening period.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. DRUG: Dupilumab, DRUG: Placebo
Asthma
To Evaluate Efficacy and Safety of Serplulimab + Chemotherapy (Carboplatin- Etoposide) in US Patients With ES-SCLC
clinicaltrials@northshore.org
ALL
18 years and over
PHASE3
NCT05468489
Inclusion Criteria:
Voluntary participation in clinical studies.
Male or female aged ≥ 18 years at the time of signing the ICF.
Histologically or cytologically diagnosed with ES-SCLC (according to the Veterans Administration Lung Study Group staging system).
No prior systemic therapy for ES-SCLC.
At least one measurable lesion as assessed according to RECIST 1.1 within 4 weeks prior to randomization.
Major organs are functioning well.
Every effort should be made to provide tumor tissues for the determination of PD-L1 expression.
An ECOG PS score of 0 or 1.
An expected survival ≥ 12 weeks.
Subjects with prior denosumab use that can and agree to switch to bisphosphonate therapy for bone metastases starting prior to randomization and throughout treatment.
Participant must keep contraception.
Exclusion Criteria:
Histologically or cytologically confirmed mixed SCLC.
Known history of severe allergy to any monoclonal antibody.
Known hypersensitivity to carboplatin or etoposide.
Patients with myocardial infarction within half a year before the first dose of the study drug, poorly controlled arrhythmia.
Pregnant or breastfeeding females.
Patients with a known history of psychotropic drug abuse or drug addiction.
Patients who have other factors that could lead to the early termination of this study based on the investigator's judgment. DRUG: Serplulimab + chemotherapy (carboplatin-etoposide), DRUG: Atezolizumab + chemotherapy (carboplatin-etoposide)
Extensive Stage Small Cell Lung Cancer
Extensive Stage Small Cell Lung Cancer, Anti-PD-1 Monoclonal Antibody
Real World Treatment Experience of Patients With Breast, Lung, Ovarian, Multiple Myeloma, or Acute Myelogenous Leukemia Using Remote Symptom Monitoring
clinicaltrials@northshore.org
All
18 years and over
NCT05974150
Inclusion Criteria:
• All participants must be 18 years of age or older.
• Subjects may be any stage and anywhere in the treatment continuum.
• Subject participants must have a diagnosis of a breast, lung, AML, ovarian cancer or multiple myeloma.
• Subjects must be able to complete on-line surveys using a cell phone, tablet, or computer.
• All participants must be able to understand English.
Exclusion Criteria:
• Any patient who cannot understand written or spoken English.
• Any patient without the ability to complete on-line surveys using a cell phone, tablet, or computer.
• Any patient on a treatment clinical trial.
• Any prisoner and/or other vulnerable persons as defined by NIH (45 CFR 46, Subpart B, C and D).
Other: Web based survey
Breast Cancer, Lung Cancer, Multiple Myeloma, Ovarian Cancer, Acute Myelogenous Leukemia
A Study to Assess Efficacy and Safety of Pembrolizumab With or Without Sacituzumab Tirumotecan (MK- 2870) in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019)
clinicaltrials@northshore.org
ALL
18 years and over
PHASE3
NCT06312137
The key inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
* Has histological or cytological confirmation of squamous or nonsquamous non-small cell lung cancer (NSCLC), resectable clinical Stage II, IIIA or IIIB (with nodal involvement \[N2\]) per AJCC eighth edition guidelines.
* Has confirmation that epidermal growth factor receptor (EGFR)-directed therapy is not indicated as primary therapy.
* Is able to undergo surgery based on opinion of investigator after consultation with surgeon.
* Is able to receive neoadjuvant pembrolizumab and platinum-based doublet chemotherapy.
* Applies to screening for the adjuvant period only, before randomization: Has not achieved pathological complete response (pCR) at surgery by local review of pathology.
* Applies to screening for the adjuvant period only, before randomization: Tumor tissue sample from surgical resection has been provided for determination of programmed cell death ligand 1 (PD-L1) and trophoblast cell surface antigen 2 (TROP2) status by central vendor before randomization into the adjuvant period.
* Applies to screening for the adjuvant period only, before randomization: Confirmed to be disease-free based on re-baseline radiological assessment as documented by contrast enhanced chest/abdomen/pelvis computed tomography (CT) (or magnetic resonance imaging (MRI)) within 28 days before randomization.
* Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement are eligible.
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART).
* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load at screening.
* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at least 4 weeks before the start of study intervention.
Exclusion Criteria:
* Has one of the following tumor locations/types:
* NSCLC involving the superior sulcus
* Large cell neuro-endocrine cancer (LCNEC)
* Sarcomatoid tumor
* Diagnosis of SCLC or, for mixed tumors, presence of small cell elements
* Documentation by local test report indicating presence of anaplastic lymphoma kinase (ALK) gene rearrangements
* Has Grade ≥2 peripheral neuropathy.
* Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing.
* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease.
* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QT corrected for heart rate by Fridericia's cube root formula (QTcF) interval to \>480 ms, and/or other serious cardiovascular and cerebrovascular diseases within the 6 months preceding study intervention.
* Has received prior neoadjuvant therapy for their current NSCLC diagnosis.
* Has received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention.
* Has received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids.
* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication.
* Has a known additional malignancy that is progressing or has required active treatment within the past 5 years.
* Has an active autoimmune disease that has required systemic treatment in the past 2 years.
* Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
* Has an active infection requiring systemic therapy.
* Is an HIV-infected participant with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
* Has a concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV deoxyribonucleic acid (DNA)) and Hepatitis C virus (defined as anti-HCV antibody (Ab) positive and detectable HCV ribonucleic acid (RNA)) infection.
* Has a severe hypersensitivity (Grade ≥3) to sacituzumab tirumotecan, any of its excipients and/or to another biologic therapy.
* Has a history of allogeneic tissue/solid organ transplant.
* Has not adequately recovered from major surgery or have ongoing surgical complications. BIOLOGICAL: Sacituzumab tirumotecan, BIOLOGICAL: Pembrolizumab, DRUG: Cisplatin, DRUG: Pemetrexed, DRUG: Gemcitabine, DRUG: Carboplatin, DRUG: Paclitaxel
Non Small Cell Lung Cancer
Carcinoma, Lung cancer, non small cell lung cancer