Studies
| Study First Submitted Date | 2020-02-27 |
| Study First Posted Date | 2020-03-02 |
| Last Update Posted Date | 2020-06-19 |
| Verification Month Year | June 2020 |
| Verification Date | 2020-06-30 |
| Last Update Posted Date | 2020-06-19 |
Conditions
| Sequence: | 52027921 |
| Name | Small Cell Lung Cancer |
| Downcase Name | small cell lung cancer |
Id Information
| Sequence: | 40046302 |
| Id Source | org_study_id |
| Id Value | LUR_EAP-001-2019 |
Interventions
| Sequence: | 52340190 |
| Intervention Type | Drug |
| Name | Lurbinectedin |
| Description | Powder for concentrate for solution for infusion in 4 mg vials |
Browse Conditions
| Sequence: | 192917709 | Sequence: | 192917710 | Sequence: | 192917711 | Sequence: | 192917712 | Sequence: | 192917713 | Sequence: | 192917714 | Sequence: | 192917715 | Sequence: | 192917716 | Sequence: | 192917717 | Sequence: | 192917718 |
| Mesh Term | Lung Neoplasms | Mesh Term | Small Cell Lung Carcinoma | Mesh Term | Respiratory Tract Neoplasms | Mesh Term | Thoracic Neoplasms | Mesh Term | Neoplasms by Site | Mesh Term | Neoplasms | Mesh Term | Lung Diseases | Mesh Term | Respiratory Tract Diseases | Mesh Term | Carcinoma, Bronchogenic | Mesh Term | Bronchial Neoplasms |
| Downcase Mesh Term | lung neoplasms | Downcase Mesh Term | small cell lung carcinoma | Downcase Mesh Term | respiratory tract neoplasms | Downcase Mesh Term | thoracic neoplasms | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | neoplasms | Downcase Mesh Term | lung diseases | Downcase Mesh Term | respiratory tract diseases | Downcase Mesh Term | carcinoma, bronchogenic | Downcase Mesh Term | bronchial neoplasms |
| Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48185498 |
| Agency Class | INDUSTRY |
| Lead Or Collaborator | lead |
| Name | Jazz Pharmaceuticals |
Eligibilities
| Sequence: | 30681263 |
| Gender | All |
| Minimum Age | 18 Years |
| Maximum Age | N/A |
| Criteria | Inclusion Criteria: Legally competent adult Confirmed and unresectable Small Cell Lung Cancer (SCLC) Patients must have received one prior chemotherapy containing line Adequate organ, hematological, kidney, metabolic and liver function Recovery from toxicities related to previous treatment(s) Pregnancy must be excluded, medically acceptable contraception method Exclusion Criteria: Prior treatment with lurbinectedin Certain concomitant diseases/conditions Symptomatic, steroid-requiring or progressive CNS involvement. Pregnant or breast-feeding women. |
| Adult | True |
| Child | False |
| Older Adult | True |
Calculated Values
| Sequence: | 253880827 |
| Registered In Calendar Year | 2020 |
| Were Results Reported | False |
| Has Single Facility | False |
| Minimum Age Num | 18 |
| Minimum Age Unit | Years |
Intervention Other Names
| Sequence: | 26595551 |
| Intervention Id | 52340190 |
| Name | PM01183 |
Responsible Parties
| Sequence: | 28794517 |
| Responsible Party Type | Sponsor |