Safety and efficacy of first-line iparomlimab and tuvonralimab (QL1706) plus carboplatin and etoposide in patients with extensive-stage small cell lung cancer: an open-label, single-arm, phase 2 trial (DUBHE-L-209).

Authors

Yun Fan, Runxiang Yang, Xuhong Min, Huiwen Ma, Yan Wang, Yanqiu Zhao, Hongmin Wang, Mingjun Zhang, Huayuan Wang, Tao Zhang, Zhehai Wang

Published in

Frontiers in immunology. Volume 17. Pages 1879524. Epub Aug 11, 2026.

Abstract

Iparomlimab and tuvonralimab (QL1706) is a MabPair product consisting of PD-1 and CTLA-4 monoclonal antibodies. This single-arm, multicenter, phase 2 study assessed the safety and efficacy of first-line QL1706 plus etoposide and carboplatin (EC) for extensive-stage small cell lung cancer (ES-SCLC).
Patients with ES-SCLC received QL1706 plus EC every 3 weeks for 4-6 cycles, followed by QL1706 maintenance therapy until disease progression. Primary endpoint was safety.
Among 40 patients enrolled, all patients experienced at least one treatment-related adverse event (TRAE). Most TRAEs were hematologic toxicities. Nine patients (22.5%) experienced immune-related adverse events, mostly grade 1-2, with a median time from treatment to the first irAE of 3.1 months (range 0.1-11.0) with a median duration of the irAEs of 1.3 months (range 0.1-10.7). Grade 3 irAEs occurred in 2 (5.0%) patients, one case each for rash and vomiting. No TRAEs leading to death or treatment discontinuation occurred. In 38 patients evaluable for efficacy, the confirmed objective response rate was 92.1% (95% confidence interval [CI] 78.6-98.3). Median progression-free survival (PFS) and overall survival (OS) were 6.0 months (95% CI 5.4-8.3) and 15.8 months (95% CI 11.4-20.0), respectively. In exploratory analyses, the median OS was 20.5 months (95% CI 11.4-not evaluable) in patients with a good lung immune prognostic index status and 19.7 months (95% CI 11.4-22.5) in patients with a combined positive score <1.
QL1706 plus EC was well-tolerated and showed promising anti-tumor activity and survival benefit in first-line treatment for ES-SCLC, and warranted further validation in larger scale phase 3 studies.

PMID:
42643500
Bibliographic data and abstract were imported from PubMed on 26 Aug 2026.

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