Research & Innovation

Lung Clinical Trials

Clinical Trials

Alliance A071701

Genomically-Guided Treatment Trial in Brain Metastases (NCT03994796)

Physician & Study Coordinator

Study Coordinator

Angela Rankin
484-658-1792
Angela.Rankin@sluhn.org

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Synopsis

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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Eligibility Criteria
  • Histologically confirmed parenchymal metastatic disease to the brain from any solid tumor

  • 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

  • Measurable CNS disease (≥ 10mm) that is new or progressive after systemic therapy or prior radiotherapy

  • Patients must be able to undergo MRI with contrast

  • Presence of clinically actionable alteration in NTRK, ROS1, CDK pathway or PI3K pathway in both a brain metastais and extracranial site per central review

  • For HER2+ breast cancer, patients must have received prior HER-2 directed therapy in the metastatic setting

  • For TNBC, patients must have had at least one chemotherpy in the metastatic setting

  • For ER and/or PR+ HER2- breast cancer, patients must have had at least one endocrine therapy in the metastatic setting

  • For melanoma, patietnts must have progressed after immunotherapy or after BRAF/MEK inhibitors for BRAF+ disease

  • For lung cancer, patients must have failed EGFR therapies for EGFR mutated disease

  • No known current diffuse leptomeningeal involvement

  • No surgery within 2 weeks prior to or after registration

  • No chemotherapy within 14 days prior to registration

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Alliance 151216

Physician & Study Coordinator

Study Coordinator

Angela Rankin RN
484-658-1792

Angela.Rankin@sluhn.org

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Synopsis

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.

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Eligibility Criteria
  • 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

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DHF 009-053P – NIGHTINGALE

Clinical Utility of Management of Patients with CT and LDCT Identified Pulmonary Nodules Using the Percepta Nasal Swab Classifier - with Familiarization

Physician & Study Coordinator

Physician

Deborah Stahlnecker, MD

Study Coordinator

Vivian Colon
484-658-1793
Vivian.Colon@sluhn.org

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Synopsis

The purpose of this research is to evaluate the usefulness of a genomic test, the Percepta Nasal Swab, in determining risk of lung cancer when a lung nodule is detected by imaging performed as part of lung cancer screening or incidentally during a medical workup.

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Eligibility Criteria
  • Patients must have a NEW lung nodule that is ≤ 30 mm identified on a CT completed < 90 days from enrollment
  • Current or former smoker; if a smoker must have smoked > 100 cigarettes in a lifetime
  • Patients must be 29-85 years of age
  • Patients may not have undergone diagnostic procedure for management of their index nodule after the index CT prior to enrollment
  • Patients may not have prior lung cancer (prior non-lung cancer acceptable); no active cancer
  • Concurrent or planned use of tools or tests for assigning lung nodule risk of malignancy (e.g., genomic or proteomic blood tests) other than clinical validated risk calculators are NOT allowed
  • Patients must be able to tolerate nasal epithelial sample collection

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ECOG 4512

A Randomized Phase III Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Observation for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein

Physician & Study Coordinator

Study Coordinator

Angela Rankin RN
484-658-1792

Angela.Rankin@sluhn.org

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Synopsis

Synopsis: Randomized Phase III Trial for Surgically Resected Early Stage NSCLC: Crizotinib VS Observation for Tumors Harboring ALK Mutations (ALCHEMIST) (NCT 02201992)

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Inclusion Criteria
  • 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.

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NRG-CC009

Phase III Trial of Stereotactic Radiosurgery (SRS) versus Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) for 10 or Fewer Brain Metastases from Small Cell Lung Cancer (NCT 04804644)

Physician & Study Coordinator

Physician

Nimisha Deb, MD

Study Coordinator

Angela Rankin
484-658-1792
Angela.Rankin@sluhn.org

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Synopsis

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.

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Eligibility Criteria
  • 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

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