Quality Awards
Lung Clinical Trials
Physician
Neil Belman, DO
Synopsis: A Randomized Phase II Trial of Cabozantinib and Cabozantinib Plus Nivolumab Versus Standard Chemotherapy in Patients with Previously Treated NonSquamous NSCLC
- Is ≥18 years of age, at the time of signing the informed consent
- Patient must have pathologically confirmed non-squamous non-small cell lung carcinoma NSCLC)
- Patient must have Stage IV disease (includes M1a, M1b, or recurrent earlier stage disease), according to the 8th edition of the lung cancer TNM classification system.
- Patient’s tumor(s) must be tested and known negative for EGFR TKI sensitizing mutations (EGFR Exon 19 deletions, L858R, L861Q, G719X) and ALK gene rearrangements.
- Patients with tumors with known molecular alterations in ROS1, MET, and RET must have progressed radiographically (per local investigator clinical assessment) on at least one line of prior chemotherapy or targeted therapy, but there is no limit on number of prior number of therapies.
- Patients WITHOUT tumors with known molecular alterations in ROS1, MET, RET or must have progressed radiographically (per local investigator assessment) following one, but only one, line of platinum-based chemotherapy AND one, but only one, line of prior immunotherapy.
Synopsis: A Prospective Blood Sample Collection Study to Develop and Validate a Panel of Protein-based Biomarkers in Patients with Pulmonary Nodules
- Is ≥18 years of age, at the time of signing the informed consent
- One or more pulmonary nodules 6 to 30 mm in largest diameter, confirmed by any radiologic modality within 90 days prior to enrollment; nodules can be newly identified or undergoing follow-up of earlier scan
- One or more pulmonary lesions/nodules >30 mm in largest diameter, confirmed by any radiologic modality within 90 days prior to enrollment
- Surgery or biopsy to confirm a pathologic diagnosis is planned or scheduled
- No prior history of any cancer with documented evidence of no cancer within 5 years of nodule detection except non-melanoma skin cancer
Physician
Neil Belman, DO
Synopsis: Phase 3 study of SBRT +/- pembrolizumab for participants with unresected stage I or IIa NSCLC
- Is ≥18 years of age, at the time of signing the informed consent
- Previously untreated NSCLC Stage I or Stage II A NSCLC (AJCC 8th edition)
- Inoperable disease due to existing medical illness(es) or anatomically unresectable tumor as determined by multidisciplinary tumor board or documented patient choice of SBRT for definitive treatment rather than surgical intervention.
- No prior treatment with anti PD-1, anti-PD-LS or with an agent directed to another stimulatory or coinhibitory T- cell receptor (ex CTLA-4, OX-40, CD 137)
- Patients must be deemed able to receive SBRT and do not have an ultra-centrally located tumor as defined in the radiation manual
Physician
Asim Ali, MD
Synopsis: A Phase 3 Radomized Placebo Controlled Double Blind Study of Romiplostim for the treatment of Chemotherapy- induced Thrombocytopenia in Patients receiving chemotherapy for treatment Non-small cell lung cancer (NSCLC), Ovarian Cancer, or Breast cancer
- Is ≥18 years of age, at the time of signing the informed consent
- Stage I, II, III, or IV locally advanced NSCLC, Breast cancer, or ovarian cancer or any stage recurrent disease.
- Patients must have platelet count less than 85 x 10^9/L on day 1 of the study
- Patients must be receiving cancer treatment wih 21 – or 28- day cycles using one of the following carboplatin- based combination chemotherapy regimens: carboplatin/ gemcitabine based, carboplatin/ premextred based, carboplatin/ liposomal doxorubicin based, or carboplatin/ taxane based (which includes either paclitaxel, nab- paclitaxel, or docetaxel)
- Patients must have at least 3 remaining planned cycles of chemotherapy at study enrollment
- No previous use of romiplostim, pegylated recombinant human megakaryocyte growth and development factor, eltromobag, recombinant human TPO, any other TPO receptor antagonist, or any investigational platelet producing agent
Physician
Neil Belman, DO
Synopsis: The purpose of this research study is to examine lung cancer patients’ surgically removed tumors for certain genetic changes, and to possibly refer these patients to a treatment study with drugs that may specifically target tumors that have these genetic changes.
- Is ≥18 years of age, at the time of signing the informed consent
- Patient Pre-Registration Eligibility Criteria:- For pre-surgical patients: Suspected resectable NSCLC IIA, IIB, IIIA, or IIIB NSCLC- For post-surgical patients: Complete resection of NSCLC, negative margins, pathologic stage IIA, IIB, IIIA or IIIB- For all patients: No prior neoadjuvant therapy (chemotherapy or radiotherapy), No prior treatment with agents targeting EGFR mutation, ALK rearrangement or PD-1/PD-L1/CTLA-4Patient
- Registration Eligibility Criteria:- Adequate tissue available for the required analyses (either clinical tissue block or slides and scrolls)
- Completely resected NSCLC, pathologic stage IIA, IIB, IIIA, IIIB- Patients need to be registered within specific timeframes based on adjuvant treatment plan
Physician
Neil Belman, DO
Synopsis: Randomized Phase III Trial for Surgically Resected Early Stage NSCLC: Crizotinib VS Observation for Tumors Harboring ALK Mutations (ALCHEMIST) (NCT 02201992)
- Is ≥18 years of age, at the time of signing the informed consent
- Previously untreated NSCLC Stage I or stage IIA NSCLC ( AJCC 8th edition)- Inoperable disease due to existing medical illness(es) or anatomically unresectable tumor as determined by multidiciplinary tumor board, or documented patient choice of SBRT for definitive treatment rather than surgical intervention
- No prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2 or with an agent directed to another stimulatory or coinhibitory T-cell receptor (ex CTLA-4, OX-40, CD137)- Patients must be deemed able to receive SBRT and do not have an ultra-centrally located tumor as defined in radiation manual.
