Phase 2 study of Nintedanib + Chemo for SCLC with IPF

What is it about?

A fatal acute exacerbation (AE) occasionally develops during chemotherapy for small-cell lung cancer (SCLC) with comorbid interstitial pneumonia (IP). Since patients with comorbid IP are excluded from most pivotal trials of the standard of care for lung cancer, there is an urgent need to establish safe and effective pharmacotherapy, especially for SCLC with comorbid idiopathic pulmonary fibrosis (IPF). The combination of nintedanib with cytotoxic chemotherapy for unresectable SCLC with IPF would be promising in terms of both suppressing chemotherapy-induced AEs and enhancing antitumor effects. This NEXT-SHIP study is a multicenter, single-arm, phase 2 trial for unresectable SCLC with IPF (N = 33). The incidence of IPF-AE at 28 days after last administration of cytotoxic chemotherapy, the primary endpoint, was 3.0% (90% confidence interval [CI]: 0.2-13.6). The median progression free survival and overall survival times were 4.2 months (95% CI: 4.2–5.5) and 13.4 months (95% CI 8.1–21.6), respectively. This study met its primary endpoint regarding the incidence of IPF-AEs with promising results for efficacy. Carboplatin, etoposide, and nintedanib combination therapy may be one of the standard treatment options for SCLC with comorbid IPF.

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Photo by Hush Naidoo Jade Photography on Unsplash

Photo by Hush Naidoo Jade Photography on Unsplash

Why is it important?

Based on these results, the combination of carboplatin, etoposide, and nintedanib is one of the safest treatment options for SCLC with comorbid IPF. Another key finding of this study is the long median OS of 13.4 months, despite the poor prognosis of SCLC with comorbid IPF. In recent years, the development and clinical application of various ICIs and antibody drug conjugates that are at high risk for drug-induced interstitial lung disease (ILD) have advanced dramatically. In this context, global interest in the evaluation of comorbid IP, a common risk factor for drug-induced ILD, and the establishment of a treatment for lung cancer with comorbid IP has been growing rapidly. We believe that the findings of this study will be of interest to clinicians.

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