A Multicenter Expanded Access Treatment Protocol of Lurbinectedin in Previously Treated SCLC in the USA


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


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


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


Sequence: 48185498
Agency Class INDUSTRY
Lead Or Collaborator lead
Name Jazz Pharmaceuticals


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