WCLC 2025 - Posters & ePosters-P3.18.31 Phase II Study of CBDCA + Nab-PTX + Tremelimumab+Durvalumab for TTF-1 Negative Advanced non-sq NSCLC (WJOG17223L, TURNING)

P3.18.31 Phase II Study of CBDCA + Nab-PTX + Tremelimumab+Durvalumab for TTF-1 Negative Advanced non-sq NSCLC (WJOG17223L, TURNING)

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The TURNING trial (WJOG17223L) is an ongoing multicenter phase II study initiated in February 2025 across 30 institutions in Japan, evaluating the efficacy and safety of a combination therapy comprising carboplatin (CBDCA), nab-paclitaxel (nab-PTX), tremelimumab, and durvalumab in patients with untreated advanced or recurrent TTF-1 negative non-squamous non-small cell lung cancer (NSCLC). TTF-1 (thyroid transcription factor-1) is a lung epithelial marker, with negativity seen in 20-30% of lung adenocarcinomas and associated with poor prognosis and worse responses to standard treatments including pemetrexed-based chemotherapy and PD-1/PD-L1 inhibitors.<br /><br />The rationale for this study is based on prior findings that tremelimumab (an anti-CTLA-4 antibody) enhances T-cell priming and tumor infiltration, and the POSEIDON trial results demonstrating improved overall and progression-free survival when tremelimumab plus durvalumab was added to chemotherapy.<br /><br />Key eligibility criteria include TTF-1 negativity, negative EGFR/ALK status, ECOG performance status 0-1, measurable lesions, and adequate organ function. Patients with active infections, autoimmune diseases, or other driver mutations (ROS1, RET, BRAF V600E, MET exon 14 skipping) were excluded.<br /><br />Treatment consists of CBDCA (AUC6) and nab-PTX (100 mg/m²) every three weeks for four cycles alongside tremelimumab (75mg) and durvalumab (1500mg), with maintenance durvalumab continued every four weeks until disease progression.<br /><br />The primary endpoint is 12-month progression-free survival (PFS) rate with a threshold of 20% and expected 35%, targeting 57 patients to ensure adequate power (80%) at a one-sided significance level of 0.05. Secondary endpoints include overall survival, objective response rate, disease control rate, and safety.<br /><br />Findings from this trial aim to clarify the benefit of this immuno-chemotherapy regimen specifically in TTF-1 negative non-squamous NSCLC, a subgroup with historically poorer outcomes under current standard treatments. The study is supported by AstraZeneca K.K.

Asset Subtitle

Motoko Tachihara

Meta Tag

Speaker Motoko Tachihara

Topic Clinical Trials in Progress

Keywords

TURNING trial

TTF-1 negative NSCLC

non-squamous non-small cell lung cancer

carboplatin

nab-paclitaxel

tremelimumab

durvalumab

immuno-chemotherapy

phase II study

AstraZeneca