This open-label randomized phase 3 trial (JCOG1914) compared daily low-dose carboplatin (30 mg/m²) vs. weekly carboplatin (AUC 2) plus nab-paclitaxel (30 mg/m²), each with concurrent thoracic radiotherapy and optional durvalumab maintenance, in patients aged ≥75 years with unresectable locally advanced NSCLC across 38 Japanese institutions (December 2020–March 2024).
The trial was stopped early for futility: Bayesian predictive probability of non-inferiority for carboplatin + nab-paclitaxel was only 8.0%. Median OS was not reached in the carboplatin-alone arm vs. 26.1 months in the combination arm (HR 1.56; 95% CI 0.79–3.11; p=0.200). The carboplatin-alone arm also had significantly better quality of life at 6 weeks (OR 0.39; 95% CI 0.18–0.81; p=0.012). Two treatment-related deaths and seven non-cancer-related deaths occurred in the combination arm.
- Trial stopped early for futility with only 124 patients enrolled, limiting statistical power for definitive OS conclusions. - Single-country (Japan) study population may limit generalizability. - Median OS was not yet reached in the control arm, making survival comparisons preliminary.
For patients aged ≥75 with unresectable LA-NSCLC, daily low-dose carboplatin with concurrent thoracic radiotherapy remains the standard of care — adding weekly nab-paclitaxel did not improve survival and worsened quality of life. Clinicians should not adopt the carboplatin + nab-paclitaxel regimen in this older population.
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