WCLC 2025 - Posters & ePosters-P3.18.25 Phase 2 Study of Carboplatin Plus Nab-Paclitaxel Rechallenge for NSCLC With Interstitial Lung Disease: TORG2442/CASTLE Study

P3.18.25 Phase 2 Study of Carboplatin Plus Nab-Paclitaxel Rechallenge for NSCLC With Interstitial Lung Disease: TORG2442/CASTLE Study

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The TORG2442/CASTLE study is a multicenter, single-arm phase II trial evaluating the efficacy and safety of rechallenging carboplatin plus nab-paclitaxel chemotherapy in patients with non-small-cell lung cancer (NSCLC) complicated by interstitial lung disease (ILD). ILD co-occurs in 2–8% of NSCLC cases, worsening prognosis and increasing risk of drug-induced lung injury and acute exacerbation (AE-ILD) during cancer treatment. While carboplatin plus nab-paclitaxel is effective and relatively safe as first-line therapy (with objective response rates [ORR] of 44–56% and AE-ILD incidence of 2–6%), treatment options following progression are limited and undefined, especially because immune checkpoint inhibitors (ICIs) pose risk in ILD patients.<br /><br />The study enrolls patients with unresectable stage III/IV or recurrent NSCLC and chronic fibrotic ILD diagnosed by HRCT (usual interstitial pneumonia or non-specific interstitial pneumonia patterns). Eligible patients have received and responded to first-line carboplatin plus nab-paclitaxel and exhibit progression 90 days or more after last treatment without prior thoracic radiotherapy or AE-ILD history. The rechallenge involves carboplatin (AUC6, day 1) and nab-paclitaxel (100 mg/m2, days 1, 8, 15), repeated every 28 days for 4–6 cycles.<br /><br />The primary endpoint is the 3-month progression-free survival (PFS) rate without AE-ILD. Secondary endpoints include ORR, disease control rate, overall survival, PFS without AE-ILD, and safety. Exploratory objectives address clinical practice patterns and platinum sensitivity. The planned sample size is 29 patients for the rechallenge phase, with an initial registration target of 150 patients.<br /><br />The study was approved by the Chiba University Clinical Review Board and registered in the Japan Registry of Clinical Trials. Enrollment began in June 2025. This trial aims to provide vital evidence for a safe and effective second-line therapy option for NSCLC patients with ILD, a population often excluded from clinical trials due to their increased risk of lung toxicity.

Asset Subtitle

Taku Itoh

Meta Tag

Speaker Taku Itoh

Topic Clinical Trials in Progress

Keywords

TORG2442

CASTLE study

non-small-cell lung cancer

NSCLC

interstitial lung disease

ILD

carboplatin

nab-paclitaxel

rechallenge chemotherapy

phase II trial