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NCT01951157 · ClinicalTrials.gov registry record · Phase 2

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 Phase 2 study of Non-small Cell Lung Cancer (NSCLC), sponsored by PharmaMar.

Completed
Registry status
Phase 2
Development phase
69
Enrollment target
1
Study location

NCT01951157: Completed Phase 2 study of Non-small Cell Lung Cancer (NSCLC), sponsored by PharmaMar.

NCT01951157 is a Phase 2 study of Non-small Cell Lung Cancer (NSCLC) that has completed, run by PharmaMar. The registered enrollment target is 69 participants, below the 284-participant average among 59 other Non-small Cell Lung Cancer (NSCLC) trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01951157, a Phase 2 study of Non-small Cell Lung Cancer (NSCLC), has completed, sponsored by PharmaMar.

COMPLETED
Registry status
Phase 2
Development phase
69 participants
Enrollment target
1
Study location

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

Primary Outcome

The rate estimate of the percentage of patients who are alive and progression-free at 16 weeks (\~4 months) after randomization. Progession disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions w

Interventions

  • DRUG Docetaxel
  • DRUG Gemcitabine
  • DRUG Lurbinectedin (PM01183)

Study Locations (1)

New York

  • - New York

Trial Details

FieldValue
Enrollment Target 69 participants
Start Date 2013-09-11
Est. Completion 2016-11
Phase Phase 2
PharmaMar

32 total trials

What the finished NCT01951157 record still lists

NCT01951157 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 284-participant average among 59 other Non-small Cell Lung Cancer (NSCLC) trials with a reported enrollment target (76% lower).

The record links to 1 condition, with Non-small Cell Lung Cancer (NSCLC) appearing as the primary indexed condition, and to 3 interventions - of which Docetaxel is the first listed.

NCT01951157 reports a single indexed study location in New York.

Frequently Asked Questions

What is clinical trial NCT01951157 about?

NCT01951157 is a clinical study titled "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 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

What is the current status of trial NCT01951157?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 69 participants. The study started on 2013-09-11. Estimated completion is 2016-11.

What conditions does trial NCT01951157 study?

This clinical trial studies the following conditions: Non-small Cell Lung Cancer (NSCLC).

What interventions are being tested in trial NCT01951157?

The interventions under investigation include: Docetaxel (DRUG), Gemcitabine (DRUG), Lurbinectedin (PM01183) (DRUG).

Who is sponsoring clinical trial NCT01951157?

This trial is sponsored by PharmaMar, which has 32 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01951157 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Non-small Cell Lung Cancer (NSCLC)

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01951157's enrollment target sits among peer trials

69 40th of 59 higher than 20 of 59 other Non-small Cell Lung Cancer (NSCLC) trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Non-small Cell Lung Cancer (NSCLC) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01951157, the US trial registry maintained by the National Library of Medicine. NCT01951157 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.