Trial reportCancer immunology, immunotherapy : CII2026
Efficacy and safety of anti-LAG-3 IBI110 in combination with sintilimab and chemotherapy for advanced squamous non-small cell lung cancer: a randomized phase II study.
Trial report in Cancer immunology, immunotherapy : CII, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04085185 (A Phase 1a, Open-label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Initial Efficacy of IBI110 in Subjects With Advanced Malignant Tumors), which is not on this map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 1a, Open-label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Initial Efficacy of IBI110 in Subjects With Advanced Malignant Tumors
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
20 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo evaluate the efficacy and safety of the anti-lymphocyte activation gene-3 (LAG-3) antibody IBI110 in combination with sintilimab and chemotherapy in patients with advanced squamous non-small cell lung cancer (sqNSCLC).
methodsIn this multicenter, randomized, open-label, phase II study, 153 patients with previously untreated advanced sqNSCLC were randomly assigned at a 1:1:1 ratio to one of three groups: IBI110 200 mg plus sintilimab (200 mg) and chemotherapy (n = 51), IBI110 600 mg plus sintilimab and chemotherapy (n = 51), or sintilimab plus chemotherapy (standard-of-care, SOC, n = 51). The primary endpoints included the objective response rate (ORR), progression-free survival (PFS) and safety. LAG-3 expression in tumor tissue was detected by immunohistochemistry (IHC) to explore its correlation with treatment efficacy.
resultsWhile no statistically significant differences in ORR, PFS, or overall survival (OS) were observed across the three arms in the overall population, promising efficacy signals emerged in the LAG-3 expression ≥ 2% subgroup. In this subset, compared with the SOC regimen, the IBI110 200 mg regimen significantly improved the duration of response (DOR: 13.73 vs. 6.51 months, P = 0.037) and PFS (P = 0.0485). The safety results indicated that the IBI110 200 mg combination was manageable, with a higher incidence of grade ≥ 3 treatment-related adverse events (56.86% vs. 29.41%) primarily consisting of controllable hematological toxicities.
conclusionThe high-LAG-3 subgroup demonstrated enhanced efficacy following the addition of IBI110 to sintilimab and chemotherapy, despite the absence of improvement in the overall population with advanced sqNSCLC, supporting further investigations in biomarker-defined patients.
trial registrationThe current study has been registered with ClinicalTrial.gov (Identifier: NCT04085185).
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.