The DOI matches its Crossref record; 13 of the 23 references it cites were found in a registry or an index, and 10 are not checked yet; none of the 18 sources its claims cite is checked for support yet.
Association Between Plasma Genotyping and Outcomes of Treatment With Osimertinib (AZD9291) in Advanced Non–Small-Cell Lung Cancer
Open accessAbstract
Purpose: Third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) have demonstrated potent activity against TKI resistance mediated by EGFR T790M. We studied whether noninvasive genotyping of cell-free plasma DNA (cfDNA) is a useful biomarker for prediction of outcome from a third-generation EGFR-TKI, osimertinib. Methods: Plasma was collected from all patients in the first-in-man study of osimertinib. Patients who were included had acquired EGFR-TKI resistance and evidence of a common EGFR-sensitizing mutation. Genotyping of cell-free plasma DNA was performed by using BEAMing. Plasma genotyping accuracy was assessed by using tumor genotyping from a central laboratory as reference. Objective response rate (ORR) and progression-free survival (PFS) were analyzed in all T790M-positive or T790M-negative patients. Results: Sensitivity of plasma genotyping for detection of T790M was 70%. Of 58 patients with T790M-negative tumors, T790M was detected in plasma of 18 (31%). ORR and median PFS were similar in patients with T790M-positive plasma (ORR, 63%; PFS, 9.7 months) or T790M-positive tumor (ORR, 62%; PFS, 9.7 months) results. Although patients with T790M-negative plasma had overall favorable outcomes (ORR, 46%; median PFS, 8.2 months), tumor genotyping distinguished a subset of patients positive for T790M who had better outcomes (ORR, 69%; PFS, 16.5 months) as well as a subset of patients negative for T790M with poor outcomes (ORR, 25%; PFS, 2.8 months). Conclusion: In this retrospective analysis, patients positive for T790M in plasma have outcomes with osimertinib that are equivalent to patients positive by a tissue-based assay. This study suggests that, upon availability of validated plasma T790M assays, some patients could avoid a tumor biopsy for T790M genotyping. As a result of the 30% false-negative rate of plasma genotyping, those with T790M-negative plasma results still need a tumor biopsy to determine presence or absence of T790M.
Checked 2026-10-06 · 10 references not checked yet
Overview
AI snapshot
Written from the paper’s full text.
TL;DR
In a retrospective analysis of the phase I AURA trial, patients with T790M detected in plasma by BEAMing had osimertinib outcomes similar to those with T790M detected in tumor tissue. Because plasma genotyping had a 30% false-negative rate for T790M, patients with T790M-negative plasma still needed tumor biopsy to determine T790M status.
Key findings
- Plasma genotyping sensitivity was 70% for T790M (111 of 158; 95% CI, 63% to 77%), 82% for exon 19 deletion (112 of 136; 95% CI, 75% to 88%), and 86% for L858R (63 of 73; 95% CI, 76% to 93%).
- Of 58 patients with T790M-negative tumors, T790M was detected in plasma in 18 (31%); repeat testing with an alternative plasma assay confirmed T790M in 14 of 18 (78%).
- ORR and median PFS were similar for T790M-positive plasma (ORR, 63%; PFS, 9.7 months) and T790M-positive tumor (ORR, 62%; PFS, 9.7 months).
- Among patients with T790M-negative plasma, tumor genotyping distinguished T790M-positive tumors (ORR, 69%; PFS, 16.5 months) from T790M-negative tumors (ORR, 25%; PFS, 2.8 months).
Methods
- Post hoc/exploratory analysis of the phase I AURA study of osimertinib in advanced EGFR-mutant NSCLC; 402 patients enrolled, 60 first-line patients excluded, 34 without a common EGFR-sensitizing mutation excluded, leaving 308 patients.
- Plasma cfDNA was collected before osimertinib and genotyped by BEAMing for T790M, L858R, and exon 19 deletion variants; positivity thresholds were ≥ 0.04% allelic fraction for exon 19 deletion or L858R and ≥ 0.06% for T790M; discordant plasma/tumor T790M results were retested with cobas plasma EGFR assay or ddPCR.
- Outcomes included confirmed ORR, maximum change in target lesion size, and PFS by RECIST version 1.1 per investigator; analyses used Clopper-Pearson exact CIs, Fisher’s exact or χ2 tests, and Kaplan-Meier estimates with log-rank tests.
Limitations
- The paper states the analysis was not preplanned, the study population was not fully representative of all acquired EGFR-TKI resistance because of intentional enrichment for T790M-positive patients, BEAMing was not performed under Clinical Laboratory Improvement Amendments conditions, and prospective validation is needed.
- Evident from the text: this was a retrospective post hoc analysis, and some key subgroups were small, such as the 18 patients with T790M-positive plasma but T790M-negative tumor genotyping.
Model-written summary. Check it against the paper before relying on it.
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A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“T790M was detected in 80% of patients (110 of 137) with versus only 5% of patients (1 of 21) without a detectable EGFR-sensitizing mutation in plasma (P<.001, Fig A2B)”
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In the paper
“Plasma genotyping resulted in rare false positives for exon 19 deletions and L858R (specificity, 98% and 97%, respectively; Table 1, Appendix Fig A2C, online only)”
Strength:plain· not yet calibratedn = 148Tests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesA result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“sensitivity of plasma genotyping for the known sensitizing mutation was 82% for exon 19 deletions (112 of 136; 95% CI, 75% to 88%)”
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In the paper
“sensitivity of plasma genotyping for EGFR-sensitizing mutations was significantly higher in patients with liver metastases (94% v 79%; P = .008)”
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In the paper
“Of 102 patients from this study with T790M-negative plasma, 45 had tumor genotyping that was positive for T790M, and these patients had a median PFS of 16.2 months, whereas 40 patients had tumor genotyping that was negative for T790M and a median PFS of 2.8 months.”
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In the paper
“and median PFS was 4.4 months (95% CI, 2.8 to 6.8 months; Appendix Fig A3, online only).”
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesA result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“In 69 patients with TKI-sensitive EGFR mutation detected in plasma (T790M negative/sens positive), ORR was 38% (26 of 69; 95% CI, 26% to 50%)”
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesA result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Of 58 patients with T790M-negative tumors, T790M was detected in plasma of 18 (31%).”
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesA result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“T790M positivity was confirmed by using an alternative assay in 14 of 18 tested plasmas (78%)”
Load-bearingStrength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesA result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Of 102 patients from this study with T790M-negative plasma, 45 had tumor genotyping that was positive for T790M, and these patients had a median PFS of 16.2 months, whereas 40 patients had tumor genotyping that was negative for T790M and a median PFS of 2.8 months.”
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- It may state two separate claims as one. 21
- Probably not a substantial claim. 8
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“If plasma genotype is positive for T790M, this may obviate the need for a biopsy—this predicts for excellent outcomes on osimertinib (ORR, 63%; median PFS, 9.7 months), similar to that observed when treating with osimertinib on the basis of tumor genotyping results (ORR, 62%; median PFS, 9.7 months).”
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A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“If plasma genotype is positive for T790M, this may obviate the need for a biopsy—this predicts for excellent outcomes on osimertinib (ORR, 63%; median PFS, 9.7 months), similar to that observed when treating with osimertinib on the basis of tumor genotyping results (ORR, 62%; median PFS, 9.7 months).”
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“median PFS was not significantly lower in those with T790M-negative plasma genotyping (8.2 months; 95% CI, 5.3 to 10.9 months; P = .188; Fig 3B).”
Load-bearingStrength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“In contrast, in 33 patients with no EGFR mutations detected (T790M negative/sens negative), ORR was higher at 64% (21 of 33; 95% CI, 45% to 79%; P = .019)”
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A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“a 9.7-month median PFS (95% CI, 8.3 to 11.1 months; Fig 3B), which is similar to outcomes in patients positive for T790M on tumor biopsy.”
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A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“ORR was surprisingly high at 46% (47 of 102; 95% CI, 36% to 56%) in patients with T790M-negative plasma genotyping; however, this was still lower than in patients with T790M-positive plasma (P = .011; Fig 2D)”
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A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“and median PFS was longer at 15.2 months (95% CI, 11.0 to 17.9 months; P = .002; Appendix Fig A3)”
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“ORR was 62% (108 of 173; 95% CI, 54% to 70%) in patients with T790M-positive tumors, higher than the 26% ORR (15 of 58; 95% CI, 15% to 39%; P < .001) in patients with T790M-negative tumors”
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A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“In patients with T790M-negative/sens-positive plasma genotyping, ORR to osimertinib was 38% and median PFS was 4.4 months.”
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A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Of 164 patients from this study with T790M-positive plasma genotyping, 18 had T790M-negative tumor genotyping, presumably as a result of heterogeneous presence of resistance mutation as a minor clone, and these patients had a response rate of 28% (5 of 18) and median PFS of 4.2 months.”
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In the paper
“In patients with T790M-negative/sens-negative plasma results, high ORR and prolonged PFS was observed.”
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None of the sources cited for this claim have been checked yet.
In the paper
“Standard of care is rapidly changing with the development of third-generation, mutant-selective EGFR-TKIs that have activity against cells that harbor TKI-sensitive EGFR mutations. Unlike conventional EGFR-TKIs, this activity is maintained in the presence of T790M resistance mutation.8,9”
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A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Our data suggest that plasma and tumor genotyping can have complementary roles for T790M testing, where plasma genotyping could be the initial step and a biopsy for tumor genotyping could be supplementary (Fig 5B).”
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In the paper
“This represents a clinical challenge because tumor genotyping for EGFR T790M requires a biopsy to be performed after resistance develops, which is a procedure that carries risks, can delay subsequent therapy, and may not always be feasible.18”
What the sources say
- Not checked yetcites [18] source
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None of the sources cited for this claim have been checked yet.
In the paper
“At least five third-generation EGFR-TKIs are in clinical development (rociletinib, osimertinib, HM61713/BI1482694, ASP8273, and EGF816) and all have reported objective response rates (ORRs) that exceed 45% in patients with EGFR-mutant NSCLC and T790M-positive resistance.12-16”
What the sources say
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“which suggests that heterogeneous presence of resistance mutations across disease sites, and not false-positives of the BEAMing assay, account for the majority of T790M tissue–plasma discordance.”
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In the paper
“Noninvasive genotyping of cell-free plasma DNA (cfDNA) represents an attractive alternative for detection of EGFR T790M, noting that plasma genotyping for EGFR-sensitizing mutations is an established alternative in Europe when tumor genotyping is not feasible.19”
What the sources say
- Not checked yetcites [19] source
Strength:boosted· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it.
None of the sources cited for this claim have been checked yet.
In the paper
“Resistance to conventional EGFR-TKIs develops after a median of 10 to 12 months and is most commonly mediated by an acquired mutation, T790M1-5.”
What the sources say
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A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Given the ease and reduced risk of plasma analysis compared with an invasive biopsy procedure, data support a new paradigm for resistance management, with rapid plasma genotyping as a diagnostic option before undergoing a tumor biopsy.”
Load-bearingStrength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesProbably not a substantial claim. It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Whereas it is a large analysis of a prospective dataset, it was not a preplanned analysis, in part because of the rapid evolution of plasma genotyping technologies.”
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Despite this discordance, outcomes in patients with T790M-positive plasma are similar to outcomes of patients with T790M-positive tumors, which highlights that a single tumor biopsy may not be representative of the spatial heterogeneity of resistant lung cancer.”
Load-bearingStrength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt may state two separate claims as one.
- Rests on an assumption: Resistant cancers are inherently more heterogeneous than treatment-naïve cancers.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Lastly, BEAMing was not performed under Clinical Laboratory Improvement Amendments conditions; this analysis used an investigational assay that is identical to the commercially available BEAMing assay.”
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“In a setting in which it is unclear whether tumor genotyping is representative of the entirety of the disease, clinical outcome will be the best reference standard for development of a noninvasive assay.”
Load-bearingStrength:plain· not yet calibratedTests✓ Asserted: passes✗ Checkable: fails✓ Load-bearing: passes✓ Based: passesProbably not a substantial claim. It may be too vague to check against evidence.
- Rests on an assumption: Resistant cancers are inherently more heterogeneous than treatment-naïve cancers.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Patients negative for T790M in plasma, however, should undergo a biopsy to determine T790M status because of the risks of false-negative plasma results.”
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesProbably not a substantial claim.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“As the plasma T790M-negative population is a mixture of true and false negatives, biopsy to further investigate the presence of T790M-positive tumor tissue is warranted (Fig 5B).”
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A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“In this example, approximately 54% of resistant patients would be T790M positive in plasma and, if treated on the basis of that result, could potentially avoid a biopsy.”
Strength:hedged· not yet calibratedCausal:conditional· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesIt may state two separate claims as one.
The paper relies on this without support.
Resistant cancers are inherently more heterogeneous than treatment-naïve cancers.
“Resistant cancers are inherently more heterogeneous than treatment-naïve cancers and, therefore, a single tumor biopsy may not be representative of the entire resistant cancer.”
The paper relies on this without support.
The BEAMing assay has negligible false positives for T790M.
“We found that 31% of patients who are negative for T790M on central tumor genotyping have detectable T790M in plasma with a BEAMing assay that otherwise has negligible false positives, though the relative AF of plasma T790M is lower in these patients than in patients with T790M-positive plasma and tumors.”
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
Each contradiction between two passages listed here was confirmed by an independent check.
Different median PFS values for the same subgroup
MinorFor patients with T790M-negative plasma but T790M-positive tumors, the Results report a median PFS of 16.5 months, while the Discussion reports 16.2 months.
“ORR was higher in patients with T790M-positive tumors (31 of 45; 69%; 95% CI, 53% to 82%) than in patients with T790M-negative tumors (10 of 40; 25%; 95% CI, 13% to 41%; P < .001), as was median PFS (16.5 months v 2.8 months; P < .001; Fig 3C).”
“Of 102 patients from this study with T790M-negative plasma, 45 had tumor genotyping that was positive for T790M, and these patients had a median PFS of 16.2 months, whereas 40 patients had tumor genotyping that was negative for T790M and a median PFS of 2.8 months.”
Response-evaluable count presented as the plasma-positive cohort size
MinorThe Results say that 164 of the 271 plasma-genotyped patients were T790M positive, but Table A1 lists 167. The 164 figure is the denominator used for ORR, not the tabulated size of the plasma-positive cohort.
“Of 271 patients with plasma genotyping, 164 were positive for T790M in plasma and displayed a 63% ORR (103 of 164; 95% CI, 55% to 70%; Fig 2C)”
“Central (plasma) T790M mutation, No. (%) Positive 167 (54.2) 129 (54.4) 167 (61.6) 129 (59.7) Negative 104 (33.8) 87 (36.7) 104 (38.4) 87 (40.3)”
Incorrect percentage for the 80 mg tumor-genotyping subgroup
MinorTable A1 reports 90 patients at 80 mg among 237 patients with central tumor genotyping. That is 38.0%, not 40.0%.
Reported 40 · recomputed 37.974684
“Osimertinib dose, No. (%) 20 mg 21 (6.8) 13 (5.5) 21 (7.7) 13 (6.0) 40 mg 52 (16.9) 43 (18.1) 52 (19.2) 43 (20.0) 80 mg 126 (40.9) 90 (40.0) 108 (39.9) 88 (40.7)”
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Metadata
- Authors
- Oxnard, G. R., Thress, K. S., Alden, R. S., Lawrance, R., Paweletz, C. P., Cantarini, M., Yang, J. C.-H., Barrett, J. C., & Jänne, P. A.
- Affiliations
- National Taiwan University (TW)
- Geoffrey R. Oxnard, Ryan S. Alden, Cloud P. Paweletz, and Pasi A. Jänne, Dana-Farber Cancer Institute, Boston; Kenneth S. Thress and J. Carl Barrett, AstraZeneca, Waltham, MA; Rachael Lawrance and Mireille Cantarini, AstraZeneca, Macclesfield, United Kingdom; and James Chih-Hsin Yang, National Taiwan University and National Taiwan University Hospital, Taipei, Taiwan.
- ORCID
- Venue
- Journal of Clinical Oncology
- Published
- 2016-10-01
- Volume
- 34
- Issue
- 28
- Pages
- 3375-3382
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- PMC
- PMC5035123
- OpenAlex
- W2468983064
- Semantic Scholar
- 120643ae96c264f871673844d9f7ad68e25ce532
- Cited by
- 850
- References
- 23
- Citations by year
- 2026: 23 · 2025: 21 · 2024: 35 · 2023: 61 · 2022: 66 · 2021: 105 · 2020: 99 · 2019: 120 · 2018: 151 · 2017: 149 · 2016: 18
- FWCI
- 130.49
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Journal of Clinical Oncology (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- AstraZeneca
- National Institutes of Health
- National Cancer Institute (R01CA135257, U01CA210171)
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Cancer Genomics and Diagnostics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
- Keywords
- osimertinib, T790M mutation, liquid biopsy, plasma cell-free DNA, beaming, EGFR tyrosine kinase inhibitors, non-small cell lung cancer, treatment response prediction, false negative rate, tumor biopsy, progression-free survival, objective response rate, first-in-man trial
- MeSH terms
- Acrylamides, Aniline Compounds, Antineoplastic Agents, Carcinoma, Non-Small-Cell Lung, DNA, Neoplasm, Genotype, Humans, Indoles, Lung Neoplasms, Piperazines, Pyrimidines, Retrospective Studies, Biomarkers, Tumor, Treatment Outcome, Disease-Free Survival, Protein Kinase Inhibitors, Kaplan-Meier Estimate, ErbB Receptors
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
A language model drew the claims from the paper on 2026-10-06, under version 3 of the claim definition (model deepseek-v4.1-flash, prompt extract-v3).
A second model labelled each claim on 2026-10-06 (model jev-1.13-20260917, definition revision gold-guideline-v0.2).
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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