Quality Awards
Lung Clinical Trials
Study Coordinator
Cynthia Evancho
484-658-2534
Cynthia.Evancho@sluhn.org
This is a Phase 2 study evaluating the efficacy of a CDK, PI3K, or NTRK/ROS1 inhibitor in patients with progressive brain metastases from solid tumors harboring the alterations predicting sensitivity to each of these inhibitors.
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Histologically confirmed parenchymal metastatic disease to the brain from any solid tumor
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Tissue must be available for biomarker testing (any brain metastasis tissue and extracranial site from any prior resection or biopsy). If extracranial tissue is not available or there is no evidence of extracrania disease, brain metastasis tissue is sufficient for eligibility
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Measurable CNS disease (≥ 10mm) that is new or progressive after systemic therapy or prior radiotherapy
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Patients must be able to undergo MRI with contrast
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Presence of clinically actionable alteration in NTRK, ROS1, CDK pathway or PI3K pathway in both a brain metastais and extracranial site per central review
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For HER2+ breast cancer, patients must have received prior HER-2 directed therapy in the metastatic setting
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For TNBC, patients must have had at least one chemotherpy in the metastatic setting
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For ER and/or PR+ HER2- breast cancer, patients must have had at least one endocrine therapy in the metastatic setting
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For melanoma, patietnts must have progressed after immunotherapy or after BRAF/MEK inhibitors for BRAF+ disease
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For lung cancer, patients must have failed EGFR therapies for EGFR mutated disease
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No known current diffuse leptomeningeal involvement
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No surgery within 2 weeks prior to or after registration
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No chemotherapy within 14 days prior to registration
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
Nicholas Taylor, 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: 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.
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.
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
The purpose of this study is to determine if high dose radiation therapy delivered only to the small areas of brain metastases from small cell lung cancer and avoiding the surrounding normal brain tissue, called stereotactic radiosurgery (SRS), will decrease side effects related to memory and thinking as compared to radiation to the entire brain while avoiding the hippocampus (the memory zone in the brain), called hippocampal-avoidant whole brain radiation therapy (HA-WBRT). The HA-WBRT will be administered in conjunction with memantine, an oral drug that helps preserve memory and thinking.
- Pathologically proven diagnosis of small cell lung cancer within 5 years of registration (de novo or recurrent small cell lung cancer are permitted)
- 10 or fewer brain metastases ≤ 3 cm in largest diameter and outside of a 5-mm margin around either hippocampus must be visible on contrast-enhanced MRI performed ≤ 21 days prior to study entry. Total tumor volume must be 30 cm3 or less
- Specific criteria related to the MRI imaging for this study must be reviewed with the PI and/or lead CRC
- Karnofsky performance score of ≥ 70
- Patients can initiate treatment with systemic (chemo and/or immunotherapy) before enrollment only if their brain metastases are asymptomatic and not located in eloquent locations (e.g. brainstem, pre-/post-central gyrus, visual cortex)
- Concurrent immunotherapy with brain radiation is permitted on trial
- Patients may have had prior intracranial surgical resection if completed at least 14 days prior to registration
- Patients with intractable seizures while on adequate anticonvulsant therapy are excluded
- Patients with prior allergic reactions to memantine are excluded
- Patients with contraindications to MR imaging are excluded
- Patients with prior radiotherapy to the brain, including SRS, WBRT, or PCI are excluded
