Protocol: 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:
- Pathologically proven diagnosis of extensive stage small cell lung cancer.
- Partial response (PR) or stable disease (SD) after 4-6 cycles of etoposide/platinum (E/P) doublet plus atezolizumab by re-staging scans.
- Measurable disease and 3 or fewer observable liver metastases and no evidence of progressive disease at time of enrollment.
- 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.
- Must be at least 18 years of age.
- ECOG Performance Status 0-2.
- Upfront radiation therapy of symptomatic metastatic site (excluding brain metastases) is permissible if causing patient pain or impending fracture.
- 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:
- Metastatic disease invading the liver (>3 metastases), heart or >10 metastatic sites detectable after induction systemic therapy.
- 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).
- Prior radiotherapy in the thorax that would result in overlapping RT fields, unless the overlapping fields meet dose constraints for this trial.