Single-arm multicenter phase II study on aggressive local consolidative therapy in combination with systemic chemotherapy for stage IV non-small cell lung carcinoma with oligometastases: CURE-OLIGO (TORG1529).

Introduction: Stage IV non-small cell lung carcinoma (NSCLC) with oligometastases is potentially curable by radical treatment. This study aimed to evaluate the efficacy and safety of chemoradiotherapy (CRT) for thoracic disease, including the primary lesion and lymph node metastases, combined with local consolidative therapy (LCT) for oligometastases.

Methods: This was a multicenter Phase II trial for patients with Stage IV NSCLC with oligometastases for whom CRT for thoracic disease was feasible. The treatment procedures included CRT containing platinum-doublet for thoracic disease and LCT for oligometastases within 8 weeks of starting or completing CRT. The primary endpoint was the 2-year survival rate.

Results: We enrolled 19 patients between June 2016 and May 2020. The median age was 68 (range: 51-74) years. Twelve patients had adenocarcinoma, and 6 had squamous cell carcinoma. The metastasis sites included the brain, bone, adrenal gland, lung, and cervical lymph node (n = 9, 7, 2, 1, and 1, respectively). All patients completed CRT concurrently with LCT for all oligometastases. There were 11 partial responses, resulting in a response rate of 58% (95% confidence interval [CI] 33.5-79.7%). Median progression-free survival and overall survival were 8.6 (95% CI 7.0-10.2) and 42.1 (80% CI 13.6-not reached) months, respectively. The 2-year survival rate was 68.4% (80% CI 52.6%-79.9%). Fourteen patients (74%) showed progression with newly observed lesions. There were no severe adverse events, and toxicities were tolerable.

Conclusion: Chemotherapy in combination with aggressive LCT for NSCLC with oligometastases might extend survival and achieve local control.

Clinical Trial Registration: University Hospital Medical Information Network, Japan (protocol identification number: UMIN000022431, first registration date: 01/JUN/2016).