zifeng-ai/TrialReviewBench huggingface dataset:
Study PMID 23610105 (2013)
Study design: Retrospective cohort study
Registration number: not mentioned
Classification of treatment: HER2‐TKIs therapy, Trastuzumab‐based therapy
Treatment: Afatinib, Lapatinib, Masatinib, Trastuzumab in combination with chemotherapy
Population: non‐small cell lung carcinoma
Gene type: HER2 exon‐20 insertion
Number of patients: 19
Outcomes: objective response rate, disease control rate
Country: France, Germany, Switzerland and Spain
Male (%): 31
Age, median (range): 60.4 (31–86)
Never-smokers (%): 52.3
Molecular diagnostics: Direct sequencing or fluorescent in‐situ hybridisation
Tumour stage: I‐IV
Study PMID 26598547 (2015)
Study design: Retrospective cohort study
Registration number: not mentioned
Classification of treatment: HER2‐TKIs therapy, Humanised monoclonal antibody
Treatment: Neratinib, Lapatinib, Afatinib, non‐small cell lung carcinoma
Population: non‐small cell lung carcinoma
Gene type: HER2 exon‐20 insertion
Number of patients: 87
Outcomes: objective response rate, disease control rate, progression‐free survival
Country: France, Switzerland, Spain, Italy, Poland, Portugal and the Netherlands
Male (%): 37.6
Age, median (range): 61 (30–87)
Never-smokers (%): 60.4
Molecular diagnostics: polymerase chain reaction or next generation sequencing
Tumour stage: I‐IV
Study PMID 25682316 (2015)
Study design: Prospective cohort study
Registration number: EudraCT: 2008–001546‐67
Classification of treatment: HER2‐TKIs therapy
Treatment: Afatinib, Afatinib plus Paclitaxel
Population: Lung adenocarcinoma
Gene type: HER2 mutation
Number of patients: 10
Outcomes: objective response rate, disease control rate
Country: Belgium, Spain, United Kingdom and United States
Male (%): 0
Age, median (range): 62 (50–79)
Never-smokers (%): 71
Molecular diagnostics: fluorescent in‐situ hybridisation
Tumour stage: IIIB/IV
Study PMID 25899785 (2015)
Study design: Phase II study
Registration number: NCT0114286
Classification of treatment: HER2‐TKIs therapy
Treatment: Dacomitinib
Population: HER2‐mutant or amplified tumours
Gene type: HER2 mutation or amplification
Number of patients: 30
Outcomes: objective response rate, disease control rate
Country: United States, China and Japan
Male (%): 50
Age, median (range): 58.7 (37–74)
Never-smokers (%): 60
Molecular diagnostics: fluorescent in‐situ hybridisation or sequencing by multiplexed testing
Tumour stage: IIIB‐IV
Study PMID 27825109 (2016)
Study design: Retrospective multicentre single‐arm study
Registration number: not mentioned
Classification of treatment: HER2‐TKIs therapy
Treatment: Afatinib
Population: non‐small cell lung carcinoma
Gene type: HER2 exon‐20 insertion
Number of patients: 4
Outcomes: disease control rate, progression‐free survival
Country: China
Male (%): 33.3
Age, median (range): 60 (39–70)
Never-smokers (%): 81
Molecular diagnostics: next generation sequencing
Tumour stage: I‐IV
Study PMID 30685684 (2017)
Study design: Retrospective study
Registration number: not mentioned
Classification of treatment: HER2‐TKIs therapy
Treatment: Afatinib
Population: Lung adenocarcinoma
Gene type: HER2mutation
Number of patients: 23
Outcomes: objective response rate, disease control rate
Country: Europe, Australia and North America
Male (%): 59
Age, median (range): 63 (40–84)
Never-smokers (%): 67
Molecular diagnostics: polymerase chain reaction or next generation sequencing
Tumour stage: IV or recurrent
Study PMID 30149884 (2018)
Study design: Retrospective study
Registration number: NCT02979821
Classification of treatment: HER2‐TKIs therapy
Treatment: Poziotinib or Afatinib
Population: Lung adenocarcinoma
Gene type: HER2 mutation
Number of patients: 7
Outcomes: objective response rate, disease control rate
Country: Korea
Male (%): 0
Age, median (range): 48.5 (55–61)
Never-smokers (%): 100
Molecular diagnostics: next generation sequencing
Tumour stage: I‐IV
Study PMID 30096481 (2018)
Study design: Retrospective single‐arm study
Registration number: not mentioned
Classification of treatment: HER2‐TKIs therapy
Treatment: Afatinib
Population: Lung adenocarcinoma
Gene type: HER2 exon 20 mutation
Number of patients: 16
Outcomes: objective response rate,disease control rate
Country: Switzerland, Israel, Taiwan, Slovenia, Austria and United States
Male (%): 43
Age, median (range): 55 (39–93)
Never-smokers (%): not mentioned
Molecular diagnostics: not mentioned
Tumour stage: IV
Study PMID 30425522 (2018)
Study design: Retrospective single‐arm study
Registration number: not mentioned
Classification of treatment: HER2‐TKIs therapy
Treatment: Afatinib
Population: Lung cancers
Gene type: HER2 exon 20 insertion
Number of patients: 19
Outcomes: objective response rate, disease control rate
Country: China
Male (%): 37
Age, median (range): 57 (41–86)
Never-smokers (%): not mentioned
Molecular diagnostics: next generation sequencing
Tumour stage: not mentioned
Study PMID 29686424 (2018)
Study design: Single‐arm phase II trial
Registration number: NCT03066206
Classification of treatment: HER2‐TKIs therapy
Treatment: Poziotinib
Population: non‐small cell lung carcinoma
Gene type: HER2 exon 20 mutation
Number of patients: 11
Outcomes: objective response rate, disease control rate
Country: United States
Male (%): not mentioned
Age, median (range): 57.6 (52–66)
Never-smokers (%): not mentioned
Molecular diagnostics: PCR‐based next generation sequencing
Tumour stage: not mentioned
Study PMID 30755741 (2018)
Study design: Single‐arm phase II trial
Registration number: NCT01953926
Classification of treatment: HER2‐TKIs therapy
Treatment: Neratinib
Population: AdvancedNSCLC
Gene type: HER2 mutation
Number of patients: 26
Outcomes: objective response rate, disease control rate
Country: United States, Spain and Australia
Male (%): 34.6
Age, median (range): 62 (46–74)
Never-smokers (%): not mentioned
Molecular diagnostics: DNA sequencing
Tumour stage: not mentioned
Study PMID 30825613 (2019)
Study design: Single‐arm phase II trial
Registration number: NCT02369484
Classification of treatment: HER2‐TKIs therapy
Treatment: Afatinib
Population: non‐small cell lung carcinoma
Gene type: HER2 exon 20 mutation
Number of patients: 13
Outcomes: objective response rate, disease control rate, progression‐free survival
Country: Poland, Netherlands, Greece, Germany, Ireland Switzerland and Spain
Male (%): 30.8
Age, median (range): 59 (39–82)
Never-smokers (%): 61.5
Molecular diagnostics: not mentioned
Tumour stage: IIIB/IV
Study PMID 31588020 (2019)
Study design: Single‐arm phase II trial
Registration number: NCT03066206
Classification of treatment: HER2‐TKIs therapy
Treatment: Poziotinib
Population: non‐small cell lung carcinoma
Gene type: HER2 mutation
Number of patients: 12
Outcomes: objective response rate, disease control rate
Country: United States
Male (%): 16.7
Age, median (range): 59.5 (56.5–61)
Never-smokers (%): not mentioned
Molecular diagnostics: not mentioned
Tumour stage: not mentioned
Study PMID 30596880 (2019)
Study design: Single‐arm phase II study
Registration number: NCT02535507
Classification of treatment: HER2‐TKIs therapy
Treatment: Pyrotinib
Population: non‐small cell lung carcinoma
Gene type: HER2 exon 20 insertion
Number of patients: 15
Outcomes: objective response rate, disease control rate, progression‐free survival
Country: China
Male (%): 53
Age, median (range): 58 (42–78)
Never-smokers (%): 67
Molecular diagnostics: ADx HER2 Mutation Detection Kit, ARMS, next generation sequencing, or DNA direct sequencing
Tumour stage: not mentioned
Study PMID 32614698 (2020)
Study design: Single‐arm phase II study
Registration number: not mentioned
Classification of treatment: HER2‐TKIs therapy
Treatment: Pyrotinib
Population: Lung adenocarcinoma
Gene type: HER2 mutation
Number of patients: 60
Outcomes: objective response rate, disease control rate
Country: China
Male (%): 45
Age, median (range): 57 (40–72)
Never-smokers (%): 71.7
Molecular diagnostics: next generation sequencing or ADx HER2 Mutation Detection Kit
Tumour stage: IIIB/IV
Study PMID 32647540 (2020)
Study design: Retrospective cohort study
Registration number: not mentioned
Classification of treatment: HER2‐TKIs therapy, Trastuzumab‐based therapy
Treatment: Afatinib or Pyrotinib, Trastuzumab‐based therapy
Population: Advanced lung cancers
Gene type: HER2 mutation
Number of patients: 28
Outcomes: objective response rate, disease control rate, progression‐free survival
Country: China
Male (%): 45
Age, median (range): 56 (32–76)
Never-smokers (%): 73
Molecular diagnostics: amplification refractory mutation system‐polymerase chain reaction or polymerase chain reaction
Tumour stage: IIIB/IV
Study PMID 14967075 (2003)
Study design: Randomised controlled trial
Registration number: not mentioned
Classification of treatment: Humanised monoclonal antibody, Trastuzumab‐based therapy
Treatment: Trastuzumab, Trastuzumab plus Docetaxel
Population: non‐small cell lung carcinoma
Gene type: HER2 protein overexpression or HER2 amplification
Number of patients: 17
Outcomes: objective response rate, disease control rate
Country: United States
Male (%): 61.5
Age, median (range): 66 (42–82)
Never-smokers (%): not mentioned
Molecular diagnostics: IHC, enzyme‐linked immunosorbent assay and fluorescent in‐situ hybridisation
Tumour stage: not mentioned
Study PMID 17947484 (2007)
Study design: Multicentre phase II study
Registration number: not mentioned
Classification of treatment: Humanised monoclonal antibody
Treatment: Pertuzumab
Population: Advanced or metastatic non‐small cell lung carcinoma
Gene type: HER2 mutation
Number of patients: 43
Outcomes: objective response rate, disease control rate, progression‐free survival
Country: United States
Male (%): 60
Age, median (range): 62 (33–79)
Never-smokers (%): not mentioned
Molecular diagnostics: IHC
Tumour stage: not mentioned
Study PMID 14981103 (2004)
Study design: Phase II trial
Registration number: ECOG 2598
Classification of treatment: Trastuzumab‐based therapy
Treatment: Trastuzumab plus Carboplatin and Paclitaxel
Population: non‐small cell lung carcinoma
Gene type: HER2 overexpression
Number of patients: 53
Outcomes: objective response rate, disease control rate, progression‐free survival
Country: United States
Male (%): 50.9
Age, median (range): 59 (52–65)
Never-smokers (%): not mentioned
Molecular diagnostics: IHC
Tumour stage: IIIB/IV, recurrent
Study PMID 14679114 (2004)
Study design: Randomised phase II study
Registration number: not mentioned
Classification of treatment: Trastuzumab‐based therapy
Treatment: Gemcitabine–cisplatin plus Trastuzumab
Population: non‐small cell lung carcinoma
Gene type: HER2‐positive
Number of patients: 51
Outcomes: objective response rate, disease control rate, progression‐free survival
Country: United States
Male (%): 65.3
Age, median (range): 58 (35–76)
Never-smokers (%): not mentioned
Molecular diagnostics: IHC, fluorescent in‐situ hybridisation or enzyme‐linked immunosorbent assay
Tumour stage: IB, IIIB/IV
Study PMID 29320312 (2018)
Study design: Phase II study
Registration number: NCT02091141
Classification of treatment: Trastuzumab‐based therapy
Treatment: Trastuzumab plus Pertuzumab
Population: non‐small cell lung carcinoma
Gene type: HER2 mutation, amplification, or overexpression
Number of patients: 30
Outcomes: objective response rate, disease control rate
Country: United States and United Kingdom
Male (%): 51
Age, median (range): 62 (23–86)
Never-smokers (%): not mentioned
Molecular diagnostics: IHC, fluorescent in‐situ hybridisation, chromogenic in‐situ hybridisation, or next generation sequencing
Tumour stage: not mentioned
Study PMID 30061586 (2018)
Study design: Single‐arm phase II study
Registration number: NCT02226757
Classification of treatment: Trastuzumab‐based therapy
Treatment: Trastuzumab and Paclitaxel
Population: Non‐squamous non‐small cell lung carcinoma
Gene type: HER2 overexpression
Number of patients: 24
Outcomes: objective response rate, disease control rate, progression‐free survival
Country: The Netherlands
Male (%): 29
Age, median (range): 68 (40–82)
Never-smokers (%): not mentioned
Molecular diagnostics: IHC
Tumour stage: IV
Study PMID 32213540 (2020)
Study design: Phase I study
Registration number: NCT02564900
Classification of treatment: Trastuzumab‐based therapy
Treatment: Trastuzumab deruxtecan (DS‐8201)
Population: non‐small cell lung carcinoma
Gene type: HER2 overexpression, or mutation
Number of patients: 18
Outcomes: objective response rate, disease control rate, progression‐free survival
Country: Japan and United States
Male (%): 27.8
Age, median (range): 58 (23–83)
Never-smokers (%): not mentioned
Molecular diagnostics: IHC or next generation sequencing
Tumour stage: not mentioned
Study PMID 29313813 (2017)
Study design: Randomised controlled trial
Registration number: not mentioned
Classification of treatment: Antibody drug conjugate, T‐DM1
Treatment: Trastuzumab emtansine (T‐DM1)
Population: Adenocarcinomas
Gene type: HER2 overexpression
Number of patients: 15
Outcomes: objective response rate, disease control rate, progression‐free survival
Country: Japan
Male (%): 47
Age, median (range): 67 (45–77)
Never-smokers (%): 67
Molecular diagnostics: IHC and fluorescent in‐situ hybridisation
Tumour stage: IV/recurrence
Study PMID 29989854 (2018)
Study design: Phase II basket trial
Registration number: NCT02675829
Classification of treatment: Antibody drug conjugate, T‐DM1
Treatment: Ado‐trastuzumab emtansine
Population: Lung cancers
Gene type: HER2 mutation, overexpression or amplification
Number of patients: 18
Outcomes: objective response rate, progression‐free survival
Country: United States
Male (%): 28
Age, median (range): 64 (47–74)
Never-smokers (%): 39
Molecular diagnostics: next generation sequencing, IHC or fluorescent in‐situ hybridisation
Tumour stage: IV/recurrence
Study PMID 30206164 (2019)
Study design: Prospective multicentre single‐arm study
Registration number: NCT02289833
Classification of treatment: Antibody drug conjugate, T‐DM1
Treatment: Trastuzumab Emtansine (T‐DM1)
Population: non‐small cell lung carcinoma
Gene type: HER2 overexpression
Number of patients: 49
Outcomes: objective response rate, progression‐free survival
Country: Switzerland, United States, Poland, Spain, Germany and Italy
Male (%): 59.2
Age, median (range): 61 (36–80)
Never-smokers (%): 20.4
Molecular diagnostics: IHC
Tumour stage: Advanced, recurrent, or metastatic