Trial reportJournal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer2019
SWOG S1400B (NCT02785913), a Phase II Study of GDC-0032 (Taselisib) for Previously Treated PI3K-Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-MAP Sub-Study).
Trial report in Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 54 papers, 3 of them syntheses that pooled it.
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
54 citing papers in PubMed, 3 syntheses or guidelines pooled it, 86 citations in OpenAlex.
- Precision Oncology Clinical Trials: A Systematic Review of Phase II Clinical Trials with Biomarker-Driven, Adaptive Design.Cancer research and treatment · 2024Pooled it
- Cost-effectiveness of immunotherapies for advanced squamous non-small cell lung cancer: a systematic review.BMC cancer · 2024Pooled it
- Risk and benefit for umbrella trials in oncology: a systematic review and meta-analysis.BMC medicine · 2022Pooled it
- Phase II study of durvalumab plus tremelimumab as therapy for patients with previously treated anti-PD-1/PD-L1 resistant stage IV squamous cell lung cancer (Lung-MAP substudy S1400F, NCT03373760).Journal for immunotherapy of cancer · 2021Trial
- Molecular subtyping and genomic profiling expand precision medicine in refractory metastatic triple-negative breast cancer: the FUTURE trial.Cell research · 2021Trial
- Biomarker-driven therapies for previously treated squamous non-small-cell lung cancer (Lung-MAP SWOG S1400): a biomarker-driven master protocol.The Lancet. Oncology · 2020Trial
- Review
- Targeting intrinsic and CAF-mediated signaling by PI3Kα inhibitor CYH33 attenuated metastasis in lung squamous cell carcinoma.Acta pharmacologica Sinica · 2026Article
- Synergistic effects through targeting the PI3K and IGFR pathways in treating lung cancer carrying activation alterations along the PI3K pathway.Translational oncology · 2026Article
- Article
- Synthesis of New Pyrazolo[1,5-a]Pyrazin-4(5H)-One Derivatives and Effects on PI3K Protein Levels in A549 Lung Adenocarcinoma Cell Line.Chemistry & biodiversity · 2026Article
- Article
- Ordinary differential equation model of cancer-associated fibroblast heterogeneity predicts treatment outcomes.NPJ systems biology and applications · 2025Article
- Review
- Efficacy of neoadjuvant immunochemotherapy in the treatment of stage III non-small-cell lung cancer with cancer driver gene mutations.Translational lung cancer research · 2025Article
- Targeting PI3K signaling in Lung Cancer: advances, challenges and therapeutic opportunities.Journal of translational medicine · 2025Review
- Durable immunotherapeutic response in molecularly complex pulmonary adenosquamous carcinoma: case report and literature review.Frontiers in immunology · 2025Review
- The continually evolving landscape of novel therapies in oncogene-driven advanced non-small-cell lung cancer.Therapeutic advances in medical oncology · 2025Review
- Lung-MAP Next-Generation Sequencing Analysis of Advanced Squamous Cell Lung Cancers (SWOG S1400).Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2024Article
- A potential therapeutic strategy based on acute oxidative stress induction for wild-type NRF2/KEAP1 lung squamous cell carcinoma.Redox biology · 2024Article
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Authors and funding
14 authors at 10 institutions in 1 country.
Funding
Abstract
backgroundS1400B is a biomarker-driven Lung-MAP substudy evaluating the phosphatidylinositol 3-kinase (PI3K) inhibitor taselisib (GDC-0032) in patients with PI3K pathway-activated squamous NSCLC (sqNSCLC).
methodsEligible patients had tumoral phosphatidylinositol-4,5-biphosphate 3 kinase catalytic subunit alpha (PIK3CA) alterations by next-generation sequencing and disease progression after at least one line of platinum-based therapy. Patients received 4-mg taselisib orally daily. The primary analysis population (PAP) was a subset of patients having substitution mutations believed to be associated with clinical benefit of PI3K inhibitors. Primary endpoint was response by Response Evaluation Criteria in Solid Tumors version 1.1; secondary endpoints included progression-free survival, overall survival and duration of response.
resultsTwenty-six patients treated with taselisib comprised the full evaluable population (FEP); 21 patients comprised the PAP. Median age for patients in the FEP was 68 years (range: 53-83 years), 19 were male (73%). The study was closed for futility at interim analysis with one responder in the PAP (5% response rate, 95% confidence interval [CI]: 0%-24%). Two possibly treatment-related deaths (one respiratory failure, one cardiac arrest) were observed; one patient had grades 4 and 11 had grade 3 adverse events. Median progression-free survival and overall survival in the PAP group were 2.9 months (95% CI: 1.8-4.0 mo) and 5.9 months (95% CI: 4.2-7.8 mo), respectively. These numbers were nearly the same in the FEP.
conclusionsStudy S1400B evaluating taselisib in PIK3CA-altered sqNSCLC failed to meet its primary endpoint and was closed after an interim futility analysis. The trial is unique in cataloguing the diversity of PIK3CA mutations in sqNSCLC.
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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.