Protocol: NRG – LU007

Please Note: Below is a partial list of eligibility, please contact GHCI Research Department at (810) 762-8181, (810) 762-8079 and/or (810) 762-8038 to discuss full eligibility requirements

Eligibility:

SCHEMA NRG-LU007

  1. Pathologically proven diagnosis of extensive stage small cell lung cancer.
  2. Partial response (PR) or stable disease (SD) after 4-6 cycles of etoposide/platinum (E/P) doublet plus atezolizumab by re-staging scans.
  3. Measurable disease and 3 or fewer observable liver metastases and no evidence of progressive disease at time of enrollment.
  4. Patients presenting with a pleural effusion will be eligible if thoracentesis is cytologically negative and non-bloody or if pleural fluid is too small a volume to effectively sample by thoracentesis and does not show increased metabolic activity on CT/PET imaging.
  5. Must be at least 18 years of age.
  6. ECOG Performance Status 0-2.
  7. Upfront radiation therapy of symptomatic metastatic site (excluding brain metastases) is permissible if causing patient pain or impending fracture.
  8. Patients with bone metastases are eligible. However, to assess response after radiation for bone metastases, must order at least diagnostic CT scan to measure response.

Ineligibility:

  1. Metastatic disease invading the liver (>3 metastases), heart or >10 metastatic sites detectable after induction systemic therapy.
  2. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for 5 years prior to randomization. Cancers with a negligible risk of metastasis or death (e.g., expected 5-year OS >90%) treated with expected curative outcome are eligible (such as adequately treated carcinoma in situ of the cervix or oral cavity; localized prostate cancer treated surgically with curative intent, or ductal carcinoma in situ treated surgically with curative intent).
  3. Prior radiotherapy in the thorax that would result in overlapping RT fields, unless the overlapping fields meet dose constraints for this trial.

 



February 22, 2021 Lung Small Cell Lung Cancer

Protocol – NRG – CC003

Please Note Below is a partial list of eligibility, please contact GHCI Research Department at (810) 762-8181, (810) 762-8079 and/or (810) 762-8038 to discuss full eligibility requirements.

Eligibility:

SCHEMA NRG-CC003

  1. Histologic proof or unequivocal cytologic proof (fine needle aspiration, biopsy or two positive sputa) of SCLC within 250 days prior to Step 1 registration. High-grade neuroendocrine carcinoma or combined SCLC and NSCLC is permitted.
  2. Patients must have received chemotherapy.
  3. For patients with extensive-stage small cell lung cancer who are being considered for consolidative thoracic radiotherapy after chemotherapy, concomitant administration of consolidative thoracic radiotherapy and protocol-specified prophylactic cranial irradiation with or without hippocampal avoidance is permitted.
  4. Prior to chemotherapy +/- thoracic radiotherapy, patients must be defined as limited-stage or extensive-stage SCLC after clinical staging evaluation.
  5. Zubrod Performance Status 0-2.
  6. Must be at least 18 years of age.

Ineligibility:

  1. Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation fields.
  2. Radiographic evidence of CNS metastases.
  3. Radiographic evidence of hydrocephalus or other architectural distortion of the ventricular system, including placement of external ventricular drain or ventriculoperitoneal shunt.
  4. Planned concurrent chemotherapy during PCI.
  5. Concomitant invasive malignancy or invasive malignancy within the past five years other than non-melanomatous skin cancer; history of in situ carcinoma (e.g. ductal carcinoma in situ of breast, in situ carcinoma of the cervix, vulva or larynx) is permitted.


PROTOCOL: NRG-LU005

Please Note: Below is a partial list of eligibility, please contact GHCI Research Department  at (810) 762-8181, (810) 762-8079 and/or (810) 762-8038 to discuss full eligibility requirements.

ELIGIBILITY:

SCHEMA NRG-LU005

  1. Pathologically (histologically or cytologically) proven diagnosis of limited stage small cell lung cancer (Stage Tx, T1-T4, N0-3, M0, AJCC Staging, 8th Ed.), within 60 days prior to registration.
  2. Patients must have received one cycle of platinum/etoposide chemotherapy preregistration (prior to study entry). Study registration must be within 21 days from day 1 of the pre-registration cycle of chemotherapy.
  3. Patients must have had measurable disease.
  4. Must be at least 18 years age.
  5. ECOG Performance Status -02.

INELIGIBILITY:

  1. Definitive clinical or radiologic evidence of metastatic disease.
  2. Definitive surgical resection of small cell lung cancer.
  3. Prior invasive malignancy (except non-melanomatous skin cancer, localized prostate
    cancer, or any early stage cancer treated with curative intent resection) unless disease free
    for a minimum of 2 years (carcinoma in situ of the breast, oral cavity, or cervix are all
    permissible).
  4. More than 1 cycle of prior platinum-based chemotherapy for SCLC prior to enrollment; note that prior chemotherapy for a different cancer is allowable.
  5. Any prior Atezolizumab or other immunotherapy agent.
  6. Prior radiotherapy to the lungs or mediastinum that would result in clinically significant overlap of radiation therapy fields; prior tangent fields for breast cancer with minimal overlap with target volumes are allowed per approval of study PIs.

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