A Phase III, Open Label, Randomised, Multi-centre, International Study of MEDI4736, Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB-IV) Who Have Received at Least Two Prior Systemic Treatment Regimens Including One Platinum Based Chemotherapy Regimen and Do Not Have Known EGFR TK Activating Mutations or ALK Rearrangements (ARCTIC). ...
This study is a Phase III, randomised, open label, multi-centre study assessing the efficacy and safety of MEDI4736 (durvalumab) versus Standard of Care in NSCLC patients with PD-L1 positive tumours and the combination of MEDI4736 (durvalumab) plus tremelimumab (MEDI4736+treme) versus Standard of Ca...
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| Language: | English |
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Vivli
2023
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| Online Access: | https://dx.doi.org/10.25934/pr00009467 https://search.vivli.org/doiLanding/studies/PR00009467/isLanding |
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ftdatacite:10.25934/pr00009467 |
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ftdatacite:10.25934/pr00009467 2023-12-31T10:04:02+01:00 A Phase III, Open Label, Randomised, Multi-centre, International Study of MEDI4736, Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB-IV) Who Have Received at Least Two Prior Systemic Treatment Regimens Including One Platinum Based Chemotherapy Regimen and Do Not Have Known EGFR TK Activating Mutations or ALK Rearrangements (ARCTIC). ... AstraZeneca 2023 https://dx.doi.org/10.25934/pr00009467 https://search.vivli.org/doiLanding/studies/PR00009467/isLanding en eng Vivli Study data may be accessed by completing a request form at https://vivli.org. It will then be reviewed according to the data contributor’s governance policy, see https://vivli.org/members/ourmembers/ for Vivli member’s review process. If approved, use of the data is governed by the data use agreement at https://vivli.org/resources/vivli-data-use-agreement/ Conditions Non - Small Cell Lung Cancer NSCLC Interventions MEDI4736 durvalumab Interventions Vinorelbine Interventions Gemcitabine Interventions Erlotinib Interventions MEDI4736 durvalumab in combination with tremelimumab anti-CTLA4 Interventions tremelimumab anti-CTLA4 Dataset dataset 2023 ftdatacite https://doi.org/10.25934/pr00009467 2023-12-01T12:21:32Z This study is a Phase III, randomised, open label, multi-centre study assessing the efficacy and safety of MEDI4736 (durvalumab) versus Standard of Care in NSCLC patients with PD-L1 positive tumours and the combination of MEDI4736 (durvalumab) plus tremelimumab (MEDI4736+treme) versus Standard of Care in NSCLC patients with PD-L1-negative tumours in the treatment of male and female patients with locally advanced or metastatic NSCLC (Stage IIIB-IV), who have received at least 2 prior systemic treatment regimens including 1 platinum-based chemotherapy regimen for NSCLC. Patients with known EGFR (Epidermal growth factor receptor) tyrosine kinase (TK) activating mutations and anaplastic lymphoma kinase (ALK) rearrangements are not eligible for the study (prospective testing is not planned within this study). The Standard of Care options are: an EGFR tyrosine kinase inhibitor (erlotinib [TARCEVA®]), gemcitabine or vinorelbine (NAVELBINE®) ... Dataset Arctic DataCite Metadata Store (German National Library of Science and Technology) |
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Open Polar |
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DataCite Metadata Store (German National Library of Science and Technology) |
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ftdatacite |
| language |
English |
| topic |
Conditions Non - Small Cell Lung Cancer NSCLC Interventions MEDI4736 durvalumab Interventions Vinorelbine Interventions Gemcitabine Interventions Erlotinib Interventions MEDI4736 durvalumab in combination with tremelimumab anti-CTLA4 Interventions tremelimumab anti-CTLA4 |
| spellingShingle |
Conditions Non - Small Cell Lung Cancer NSCLC Interventions MEDI4736 durvalumab Interventions Vinorelbine Interventions Gemcitabine Interventions Erlotinib Interventions MEDI4736 durvalumab in combination with tremelimumab anti-CTLA4 Interventions tremelimumab anti-CTLA4 AstraZeneca A Phase III, Open Label, Randomised, Multi-centre, International Study of MEDI4736, Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB-IV) Who Have Received at Least Two Prior Systemic Treatment Regimens Including One Platinum Based Chemotherapy Regimen and Do Not Have Known EGFR TK Activating Mutations or ALK Rearrangements (ARCTIC). ... |
| topic_facet |
Conditions Non - Small Cell Lung Cancer NSCLC Interventions MEDI4736 durvalumab Interventions Vinorelbine Interventions Gemcitabine Interventions Erlotinib Interventions MEDI4736 durvalumab in combination with tremelimumab anti-CTLA4 Interventions tremelimumab anti-CTLA4 |
| description |
This study is a Phase III, randomised, open label, multi-centre study assessing the efficacy and safety of MEDI4736 (durvalumab) versus Standard of Care in NSCLC patients with PD-L1 positive tumours and the combination of MEDI4736 (durvalumab) plus tremelimumab (MEDI4736+treme) versus Standard of Care in NSCLC patients with PD-L1-negative tumours in the treatment of male and female patients with locally advanced or metastatic NSCLC (Stage IIIB-IV), who have received at least 2 prior systemic treatment regimens including 1 platinum-based chemotherapy regimen for NSCLC. Patients with known EGFR (Epidermal growth factor receptor) tyrosine kinase (TK) activating mutations and anaplastic lymphoma kinase (ALK) rearrangements are not eligible for the study (prospective testing is not planned within this study). The Standard of Care options are: an EGFR tyrosine kinase inhibitor (erlotinib [TARCEVA®]), gemcitabine or vinorelbine (NAVELBINE®) ... |
| format |
Dataset |
| author |
AstraZeneca |
| author_facet |
AstraZeneca |
| author_sort |
AstraZeneca |
| title |
A Phase III, Open Label, Randomised, Multi-centre, International Study of MEDI4736, Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB-IV) Who Have Received at Least Two Prior Systemic Treatment Regimens Including One Platinum Based Chemotherapy Regimen and Do Not Have Known EGFR TK Activating Mutations or ALK Rearrangements (ARCTIC). ... |
| title_short |
A Phase III, Open Label, Randomised, Multi-centre, International Study of MEDI4736, Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB-IV) Who Have Received at Least Two Prior Systemic Treatment Regimens Including One Platinum Based Chemotherapy Regimen and Do Not Have Known EGFR TK Activating Mutations or ALK Rearrangements (ARCTIC). ... |
| title_full |
A Phase III, Open Label, Randomised, Multi-centre, International Study of MEDI4736, Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB-IV) Who Have Received at Least Two Prior Systemic Treatment Regimens Including One Platinum Based Chemotherapy Regimen and Do Not Have Known EGFR TK Activating Mutations or ALK Rearrangements (ARCTIC). ... |
| title_fullStr |
A Phase III, Open Label, Randomised, Multi-centre, International Study of MEDI4736, Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB-IV) Who Have Received at Least Two Prior Systemic Treatment Regimens Including One Platinum Based Chemotherapy Regimen and Do Not Have Known EGFR TK Activating Mutations or ALK Rearrangements (ARCTIC). ... |
| title_full_unstemmed |
A Phase III, Open Label, Randomised, Multi-centre, International Study of MEDI4736, Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB-IV) Who Have Received at Least Two Prior Systemic Treatment Regimens Including One Platinum Based Chemotherapy Regimen and Do Not Have Known EGFR TK Activating Mutations or ALK Rearrangements (ARCTIC). ... |
| title_sort |
phase iii, open label, randomised, multi-centre, international study of medi4736, given as monotherapy or in combination with tremelimumab determined by pd-l1 expression versus standard of care in patients with locally advanced or metastatic non-small cell lung cancer (stage iiib-iv) who have received at least two prior systemic treatment regimens including one platinum based chemotherapy regimen and do not have known egfr tk activating mutations or alk rearrangements (arctic). ... |
| publisher |
Vivli |
| publishDate |
2023 |
| url |
https://dx.doi.org/10.25934/pr00009467 https://search.vivli.org/doiLanding/studies/PR00009467/isLanding |
| genre |
Arctic |
| genre_facet |
Arctic |
| op_rights |
Study data may be accessed by completing a request form at https://vivli.org. It will then be reviewed according to the data contributor’s governance policy, see https://vivli.org/members/ourmembers/ for Vivli member’s review process. If approved, use of the data is governed by the data use agreement at https://vivli.org/resources/vivli-data-use-agreement/ |
| op_doi |
https://doi.org/10.25934/pr00009467 |
| _version_ |
1786828689518886912 |