Randomized Phase II/III Trial of Consolidation Radiation + Immunotherapy for ES-SCLC RAPTOR TRIAL

January 26, 2022

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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