Phase 2
Completed N=69
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
Source: ClinicalTrials.gov NCT01951157 ↗Enrolled (actual)
69
Serious AEs
57.4%
Results posted
Sep 2019
Primary outcomePrimary: Progression-free Survival Rate at Four Months (PFS4) — 27.3; 15.8; 26.1 percentage of participants
Summary
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival Rate at Four Months (PFS4) |
27.3; 15.8; 26.1 | — |
| SECONDARY Progression-free Survival |
3.1; 1.9; 3.3 | = 0.3873 |
| SECONDARY Progression-free Survival Rate at Six Months (PFS6) |
18.2; 16.7; 17.5 | — |
| SECONDARY Overall Response Rate |
9.1; 0; 17.4 | — |
| SECONDARY Objective Response Per RECIST v.1.1 |
2; 0; 4; 10; 7; 11 | — |
| SECONDARY Duration of Response |
1.2; 6.1 | = 0.0177 sig |
| SECONDARY Overall Survival (OS) |
9.4; 5.5; 7.2 | 0.3526 |
| SECONDARY Information on Quality of Life (QoL) |
27.2; 36.4; 38.1; 29.5; 32.2; 36.4 | 0.9026 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01951157). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.