Trial reportClinical lung cancer2026
Efficacy of Neratinib-Based Therapy in ERBB2-Mutant Lung Adenocarcinomas: Findings From 2 International Phase 2 Studies.
Trial report in Clinical lung cancer, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 2 papers.
What it found
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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 2 Study of Neratinib and Neratinib Plus Temsirolimus in Patients With Non-Small Cell Lung Cancer Carrying Known HER2 Activating Mutations
An Open-Label, Phase 2 Basket Study of Neratinib in Patients With Solid Tumors With Somatic Activating HER Mutations
Who cites it
2 citing papers in PubMed.
- New Treatment Strategies for Rare Genomic Alterations:Cancers · 2026Review
- Evaluating zongertinib in the treatment of patients with HER2-mutant non-small cell lung cancer.Future oncology (London, England) · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
25 authors.
Funding
Abstract
backgroundERBB2 mutations are oncogenic drivers in 2% to 4% of lung cancers and potentially actionable using HER2 tyrosine kinase inhibitors. PATIENTS AND
methodsPatients with advanced ERBB2-mutant lung cancer entered 2 phase 2 studies (PUMA-NER-4201 [4201]; PUMA-NER-5201 [SUMMIT]). Patients received neratinib (monotherapy 4201; monotherapy SUMMIT), or neratinib with weekly temsirolimus (combination 4201), or trastuzumab every 3 weeks (combination SUMMIT). Protocol-defined endpoints common to both studies were analyzed. Exploratory genomic analyses were conducted. CLINICALTRIALS: gov: NCT01827267; NCT01953926.
resultsSixty patients in 4201 (neratinib, n = 17; neratinib plus temsirolimus, n = 43) and 78 in SUMMIT (neratinib, n = 26; neratinib plus trastuzumab, n = 52) received study treatment. Objective response rates were 0% (95% confidence interval [CI], 0.0-19.5; 4201) and 3.8% (95% CI, 0.1-19.6; SUMMIT) with neratinib, 14.0% (95% CI, 5.3-27.9) with neratinib plus temsirolimus, and 9.6% (95% CI, 3.2-21.0) with neratinib plus trastuzumab. Five patients whose tumors harbored ERBB2 exon 20 insertion, L755P and D769Y missense mutations, and a novel ERBB2-SHC1 fusion had responses ≥ 1 year (neratinib monotherapy, n = 1; SUMMIT; neratinib plus temsirolimus, n = 2; neratinib plus trastuzumab, n = 2). Grade ≥ 3 treatment-related adverse events occurred in 23.5% (4201) and 34.6% (SUMMIT) of neratinib-treated patients, 37.2% of patients treated with neratinib plus temsirolimus, and 48.1% of patients treated with neratinib plus trastuzumab.
conclusionSingle-agent neratinib has limited activity in ERBB2-mutated lung cancers. Combinations with temsirolimus or trastuzumab did not markedly improve overall outcomes, producing durable responses in a limited subset of patients.
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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.