Protocol: SWOG – S1929

SCHEMA SWOG S1929

Please Note: Below is brief eligibility, for full eligibility requirement’s, please contact GHCI Research Department at (810) 762-8181, (810) 762-8079 and/or (810) 762-8038. Thank you!

Eligibility:

  1. Participants must have histologically or pathologically confirmed diagnosis of extensive stage small cell lung cancer (ES-SCLC). Participants who have transformed to
    SCLC from NSCLC or have SCLC with mixed histology are not eligible.
  2. Participants must have completed at least day 3 of cycle 1 dosing of frontline induction treatment with platinum plus etoposide plus atezolizumab prior to Step 1 Screening Registration. Cycle 1 of frontline induction treatment may or may not contain atezolizumab. NOTE: Participants may be screened while receiving consolidation
    thoracic radiation or during prophylactic cranial irradiation (PCI) at the time of Step 1 Screening Registration. Participants may or may not receive consolidation thoracic radiation and/or PCI per the discretion of their treating investigator.
  3. Participants must not have received any immunotherapy for SCLC prior to starting the frontline induction treatment for ES-SCLC.
  4. Participants must not have received any investigational agent for the treatment of ES-SCLC.
  5. ≥ 18 years of age.
  6. Participants must have adequate tumor tissue available from a core biopsy or fine needle aspiration


Protocol: NRG – LU007

SCHEMA NRG LU007

Please Note: Below is partial eligibility, for full eligibility requirement’s, please contact GHCI Research Department at (810) 762-8181, (810) 762-8079 and/or (810) 762-8038. Thank you!

Eligibility:

  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.

 


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