A Clinical Study in Three-arm of Lurbinectedin (PM01183) alone or in combination with Gemcitabine and a control arm with Docetaxel as second-line treatment in Small Cell Lung Cancer (NSCLC) patients.
- Conditions
- nresectable Non-Small Cell Lung Cancer (NSCLC).MedDRA version: 18.0Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-000548-25-BE
- Lead Sponsor
- Pharma Mar S.A. Sociedad Unipersonal
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
1) Voluntary written IC of the patient obtained before any study-specific procedure.
2) Histologically or cytologically confirmed unresectable NSCLC.
3) Patients must have failed one prior line of CT-based therapy for unresectable disease.
4) Age between 18 and 75 years, both inclusive.
5) Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 1.
6) Adequate hematological, renal, metabolic and hepatic function:
a) Hemoglobin = 9 g/dl (patients may have received prior red blood cell [RBC] transfusion up to 48 hours before
treatment start, if clinically indicated), absolute neutrophil count (ANC) = 2.0 x 109/l, and platelet count = 100 x 109/l.
b) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 3.0 x upper limit of normal (ULN).
c) Total bilirubin = ULN.
d) Albumin = 3.0 g/dl.
e) Calculated creatinine clearance (CrCl) = 30 ml/minute (using Cockcroft and Gault’s formula).
f) Creatine phosphokinase (CPK) = 2.5 x ULN.
7) At least four weeks (if the patient received a total dose = 30 Gy)/two weeks (if the patient received a total dose < 30 Gy) since the last prior therapy, at least four weeks since completion of any prior radiotherapy and recovery to grade = 1 from any adverse event (AE) derived from previous anticancer treatment, except alopecia, sensory neuropathy, anemia or asthenia (all of which must have recovered to grade = 2) according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, v.4).
8) Pre-menopausal women must have a negative pregnancy test before treatment start and not be breast feeding. Both women and men must agree to use a medically acceptable method of contraception throughout the treatment period and for at least six months after treatment discontinuation. Acceptable methods of contraception include intrauterine device (IUD), oral contraceptive,
subdermal implant, double barrier and/or complete abstinence (non-periodic).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 84
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 36
1) Concomitant diseases/conditions:
a) History (within the last year) or presence of unstable angina, myocardial infarction, symptomatic congestive heart failure or asymptomatic with left ventricular ejection fraction (LVEF) = 50% (assessed by multiple-gated acquisition scan [MUGA] or equivalent by ultrasound [US]) or clinically significant valvular heart disease.
b) Patients with dyspnea at rest or requiring any oxygen support within the last four weeks.
c) Known infection by human immunodeficiency virus (HIV), including seropositive patients without AIDs.
d) Chronic active hepatitis or cirrhosis. For Hepatitis B, this includes positive tests for both Hepatitis B surface antigen and Hepatitis B quantitative polymerase chain
reaction (qPCR). For Hepatitis C, this includes positive tests for both Hepatitis C antibody and Hepatitis C qPCR.
e) Active uncontrolled infection; patients undergoing active antibiotherapy for an ongoing infection must have finished treatment at least one week before treatment start.
f) Pleural or pericardial effusions requiring invasive management procedures.
g) Known myopathy of any cause.
h) Limitation of the patient’s ability to comply with the treatment or to follow-up the protocol.
I) Any other major illness that, in the Investigator’s judgment, will substantially increase the risk associated with the patient’s participation in this study.
2) More than one prior line of CT for advanced or unresectable disease.
3) Histological features of neuroendocrine or bronchioalveolar differentiation.
4) Unknown epidermal growth factor receptor (EGFR) mutation status or previously known EGFR mutated status in patients with adenocarcinoma.
5) Prior or concurrent invasive malignant disease, unless in complete remission for more than three years. Exceptions are completely resected or definitively treated squamous cell carcinoma of the cervix or head and neck without lymphatic spread, cutaneous basal cell carcinoma or superficial transitional cell carcinoma of the bladder.
6) Significant cancer-related weight loss (=10%) within four weeks prior to treatment start.
7) Prior treatment with gemcitabine or docetaxel-containing therapy (one full infusion at least completed).
8) Symptomatic, steroid-requiring or progressive CNS involvement. If there is prior or current, known or suspected CNS involvement, clinical stability and lack of radiological progression of lesions should be demonstrated for at least the immediate six weeks before study entry.
9) Ongoing symptomatic paraneoplastic syndromes.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method