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CompletedPhase 2NCT01951157
Official study title

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

Study 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

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedDocetaxel and Gemcitabine

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Early-stage or resectable

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 24, 2019 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?PharmaMar

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
PharmaMar
Interventions being studied
Drug: Docetaxel; Drug: Gemcitabine; Drug: Lurbinectedin (PM01183)
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Early-stage or resectable→
Treatment approach
Chemotherapy→
Study topics
After prior treatment→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Study locationNew York, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 24, 2019. Always confirm current availability with the study team.

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