Research & Innovation

Lung Clinical Trials

Clinical Trials

AstraZeneca D926TC00001 TROPION-Lung 12

A Phase III, Randomised, Open-label, Global Study of Adjuvant Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma Non-small Cell Lung Cancer who are ctDNA-positive or Have High-risk Pathological Features (TROPION-Lung12) (NCT06564844).

Physician & Study Coordinator

Physician

Neil Belman, DO

Study Coordinator

Angela Rankin
email: Angela.Rankin@sluhn.org
phone: 484-658-1792

 

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Synopsis

The purpose of this study is to learn more about whether an investigational drug called rilvegostomig, when used alone or in combination with another anti-cancer drug called datopotamab deruxtecan (also called Dato-DXd), given intravenously (IV) after surgery, will work and be safe for the treatment of patients with Stage I adenocarcinoma NSCLC. You will meet one of the eligibility criteria for this study if your pre-surgical circulating tumor DNA (ctDNA) blood test result is positive (stage IA or IB), or high-risk features are found in your tumor sample from surgery (if your cancer is Stage IB). There are two parts of this study. The first part is to test for ctDNA via a blood test. The second part is the treatment part which occurs after you have completed surgery.

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Eligibility Criteria

Your doctor will determine whether this clinical trial is an appropriate option for you. Some key eligibility criteria are as follows:

  • Patients must have clinical stage I adenocarcinoma non-small cell lung cancer
  • Patients must consent to test for ctDNA prior to surgery
  • ctDNA-positive result for stage IA
  • ctDNA-positive or ctDNA-negative with pathological high-risk features for stage IB
  • Complete surgical resection of the primary lung cancer with unequivocal no evidence of disease at the post-surgical baseline radiological imaging
  • The lung cancer must be negative for EGFR and ALK mutations
  • Patients must be fully recovered from surgery and able to start on treatment within 12 weeks of surgery
  • Patients must be  18 years of age with a performance status of 0-1
  • Patients must have a life expectancy of > 6 months

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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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Nanobiotix 1100

A Phase I Study of NBTXR3 Activated by Radiotherapy for Patients with Advanced Cancers Treated With An Anti-PD-1 Therapy (NCT 03589339)

Physician & Study Coordinator

Physician

William Smith, MD

Study Coordinator

Angela Rankin
email: Angela.Rankin@sluhn.org
phone: 484-658-1792

 

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Synopsis

The purpose of this research is to determine the recommended dose(s), safety, efficacy and tolerability of the study drug NBTXR3. NBTXR3 is a sterile white suspension made of hafnium oxide nanoparticles that will be injected directly into the tumor. NBTXR3 is an experimental drug made of extremely small particles with a special coating designed to get inside and stay inside cancer cells. These particles are designed to improve the benefit of Radiation Therapy to treat your cancer. It will be directly injected into a tumor that will then be radiated. After completion of radiation, patients will undergo treatment with immunotherapy with an anti-PD-1 inhibitor at the direction of their medical oncologist.

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Eligibility Criteria

Your study doctor will determine whether this clinical trial is an appropriate option for you. Some key eligibility criteria are as follows:

  • Patients must have biopsy-confirmed advanced/unresectable malignant solid tumor diagnosis indicated to receive an FDA-approved anti-PD-1 therapy that:
    • Is inoperable locoregional recurrent or metastatic HNSCC with at least one lesion that is amenable to irradiation within head and neck region, lung or liver
    • Is inoperable cancer of the lung, liver, kidney, bladder, cervix, breast (triple negative) or malignant melanoma that has metastasized to soft tissues, lung (including mediastinal lymph nodes) or liver with at least one lesion that is amenable to irradiation
  • Patients must have received prior anti-PD-1 therapy and meet criteria consistent with anti-PD-1 primary or secondary resistance or have not received anti-PD-1 therapy (i.e., anti-PD1 naïve)
  • Patients must have at least one tumor lesion that can be accurately measured according and is amenable for intratumoral injection and amenable for irradiation, as determined by the study investigator
  • Patients cannot have a history of immune-related adverse events related to the administration of anti-PD-1/L1 that led to the termination of the previous anti-PD-1 therapy due to intolerance or toxicity and precludes further PD-1 exposure.
  • Symptomatic central nervous system metastases and/or carcinomatous meningitis is not allowed
  • Active autoimmune disease that has required systemic treatment in 1 year before study treatment (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) is not allowed
  • Extensive metastatic disease burden defined as more than five lesions overall including the primary tumor is not allowed
  • Patients must not have received prior systemic anti-neoplastic therapy, including investigational agents, within 4 weeks prior to NBTXR3 injection
  • Patient must not have received prior therapy with a checkpoint inhibitor (e.g., anti-CTLA-4, anti-PD-1/L1, and/or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways) within two weeks prior to NBTXR3 injection

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NRG-LU007

Randomized Phase II/III Trial of Consolidation Radiation + Immunotherapy for ES-SCLC: RAPTOR trial (NCT 04402788).

Physician & Study Coordinator

Physician

William Smith, MD

Study Coordinator

Angela Rankin
email: Angela.Rankin@sluhn.org
phone: 484-658-1792

 

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Synopsis

The purpose of this study is to help determine if the addition of radiation therapy to immune therapy (atezolizumab) alone after initial treatment with chemotherapy plus immune therapy (atezolizumab) can extend the progression-free survival of patients with extensive-stage small cell lung cancer. The usual approach to treatment for extensive-stage small cell lung cancer after initial treatment with chemotherapy and immune therapy is maintenance with immune therapy alone. Patients may also have whole brain radiation, called prophylactic cranial irradiation, after completing chemotherapy plus immune therapy to help prevent cancer spreading to the brain.

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Eligibility Criteria

Your doctor will determine whether this clinical trial is an appropriate option for you. Some key eligibility criteria are as follows:

  • Confirmation of extensive stage small cell lung cancer at any stie, either primary or metastases
  • Partial response or stable disease after 4-6 cycles of etoposide/platinum doublet chemotherapy plus atezolizumab by re-staging imaging
  • Enrollment onto study must occur within 9 weeks from last dose of etoposide/platinum if no prophylactic cranial irradiation is given, or within 6 week from completion of prophylactic cranial irradiation
  • There must be measurable disease and 3 or fewer observable liver metastases and no evidence of progressive disease at time of enrollment
  • Patients must be ≥ 18 year of age
  • Patients must have an ECOG performance status of 0-2 within 14 days of enrollment
  • Patients with brain metastases are eligible for study after receiving whole brain radiation before enrollment (anytime during induction systemic therapy). Patients must be neurologically stable and do not require steroids above a dose of 10 mg of prednisone daily after completing radiotherapy.

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