Clinical trial · Interventional
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 Non-Small Cell Lung Cancer (NSCLC) Patients
A Randomized-Controlled Three-arm Phase II Study of Lurbinectedin (PM01183) Alone or In Combination With Gemcitabine and a Control Arm With Docetaxel as Second-Line Treatment in Unresectable Non-Small Cell Lung Cancer (NSCLC) Patients
NCT01951157CI-TRIAL-00040793completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A clinical study of lurbinectedin(PM01183) alone or in combination with gemcitabine in comparison to docetaxel for the treatment of unresectable non-small cell lung cancer (NSCLC)patients
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer (NSCLC) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Lurbinectedin (PM01183) | Drug | Lurbinectedin | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- A - docetaxel
- description
- 75 mg/m2 docetaxel day 1, 1-hour intravenous, every three weeks
- interventionNames
- Drug: Docetaxel
- type
- EXPERIMENTAL
- label
- B - lurbinectedin (PM01183)
- description
- 3.2 mg/m2 PM01183, day 1, 1-hour intravenous, every three weeks
- interventionNames
- Drug: Lurbinectedin (PM01183)
- type
- EXPERIMENTAL
- label
- C - gemcitabine + lurbinectedin (PM01183)
- description
- 800 mg/m2 gemcitabine / 1.6 mg/m2 PM01183 both on day 1 and day 8, 30-minutes gemcitabine/1-hour PM01183 intravenous, every three weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed unresectable NSCLC * Patients must have failed one prior line of CT-based therapy for unresectable disease * Age between 18 and 75 years * Eastern Cooperative Oncology Group (ECOG)performance status (PS) ≤ 1 * Adequate hematological, renal, metabolic and hepatic function * At least three weeks since the last prior therapy, at least four weeks since completion of any prior radiotherapy * Negative pregnancy test for pre-menopausal women Exclusion Criteria: * Concomitant diseases/conditions as unstable angina, myocardial infarction, symptomatic congestive heart failure or asymptomatic with left ventricular ejection fraction (LVEF) ≤ 50%, dyspnea, infection by human immunodeficiency virus (HIV), active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, active uncontrolled infection, pleural or pericardial effusions, myopathy, limitation of the patient's ability to comply with the treatment or to follow-up the protocol, any other major illness * Histological features of neuroendocrine or bronchioalveolar differentiation. * Unknown epidermal growth factor receptor (EGFR)mutation status or previously known EGFR mutated status in patients with adenocarcinoma. * Prior or concurrent invasive malignant disease, unless in complete remission for more than three years. * Significant cancer-related weight loss (≥10%)within four weeks prior to treatment start * Prior treatment with docetaxel-containing therapy * Symptomatic, steroid-requiring or progressive central nervous system (CNS) involvement * Paraneoplastic syndromes
References
Publications (0)
Data not yet available
No reference posted for this study.