ArticleClinical cancer research : an official journal of the American Association for Cancer Research2012
Design of a phase III clinical trial with prospective biomarker validation: SWOG S0819.
Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
19 citing papers in PubMed, 43 citations in OpenAlex.
- Trial
- Cetuximab plus carboplatin and paclitaxel with or without bevacizumab versus carboplatin and paclitaxel with or without bevacizumab in advanced NSCLC (SWOG S0819): a randomised, phase 3 study.The Lancet. Oncology · 2018Trial
- Weekly and every 2 weeks cetuximab maintenance therapy after platinum-based chemotherapy plus cetuximab as first-line treatment for non-small cell lung cancer: randomized non-comparative phase IIIb NEXT trial.Targeted oncology · 2015Trial
- Estimating individualized treatment rules by optimizing the adjusted probability of a longer survival.Statistical methods in medical research · 2024Article
- Quantifying treatment effects using the personalized chance of longer survival.Statistics in medicine · 2019Article
- Immune-Checkpoint Blockade Opposes CD8Cancer immunology research · 2019Article
- Discussion of Trial Designs for Biomarker Identification and Validation Through the Use of Case Studies.JCO precision oncology · 2019Article
- Phase III Precision Medicine Clinical Trial Designs That Integrate Treatment and Biomarker Evaluation.JCO precision oncology · 2019Review
- Challenges and future of biomarker tests in the era of precision oncology: Can we rely on immunohistochemistry (IHC) or fluorescenceOncotarget · 2017Review
- An adaptive design for updating the threshold value of a continuous biomarker.Statistics in medicine · 2016Article
- Introducing Cytology-Based Theranostics in Oral Squamous Cell Carcinoma: A Pilot Program.Pathology oncology research : POR · 2016Article
- Clinical trial designs incorporating predictive biomarkers.Cancer treatment reviews · 2016Review
- Drug designs fulfilling the requirements of clinical trials aiming at personalizing medicine.Chinese clinical oncology · 2014Article
- Biomarker enrichment strategies: matching trial design to biomarker credentials.Nature reviews. Clinical oncology · 2014Review
- Biomarker-guided repurposing of chemotherapeutic drugs for cancer therapy: a novel strategy in drug development.Frontiers in oncology · 2013Review
- Phase III clinical trials that integrate treatment and biomarker evaluation.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2013Article
- Impact of bioinformatic procedures in the development and translation of high-throughput molecular classifiers in oncology.Clinical cancer research : an official journal of the American Association for Cancer Research · 2013Review
- Fool's gold, lost treasures, and the randomized clinical trial.BMC cancer · 2013Article
- How to develop treatments for biologically heterogeneous "diseases".Clinical cancer research : an official journal of the American Association for Cancer Research · 2012Article
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Authors and funding
5 authors at 2 institutions in 1 country.
Funding
Abstract
The role of cetuximab in the treatment of advanced non-small cell lung cancer (NSCLC) is currently unclear. The molecular target of cetuximab, epidermal growth factor receptor (EGFR), as measured by FISH, has shown potential as a predictive biomarker for cetuximab efficacy in NSCLC. SWOG S0819 is a phase III trial evaluating both the value of cetuximab in this setting and EGFR FISH as a predictive biomarker. This work describes the decision process for determining the design and interim monitoring plan for S0819. Six possible designs were evaluated in terms of their properties and the hypotheses that can be addressed within the design constraints. A subgroup-focused, multiple-hypothesis design was selected for S0819 that incorporates coprimary endpoints to assess cetuximab in both the overall study population and among EGFR FISH-positive (FISH(+)) patients, with the sample size determined based on evaluation in the EGFR FISH(+) group. The chosen interim monitoring plan specifies interim evaluations of both efficacy and futility in the EGFR FISH(+) group alone. The futility-monitoring plan to determine early stopping in the EGFR FISH-nonpositive group is based on evaluation within the positive group, the entire study population, and the nonpositive group. SWOG S0819 uses a design that addresses both the biomarker-driven and general-efficacy objectives of this study.
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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.