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NCT02426658 · ClinicalTrials.gov registry record · Phase 2

Pemetrexed Disodium in Treating Patients With Stage IV Non-small Cell Lung Cancer and ECOG Performance Status 3

A Phase 2 study, sponsored by Wake Forest University Health Sciences.

Completed
Registry status
Phase 2
Development phase
16
Enrollment target

NCT02426658: Completed Phase 2 study, sponsored by Wake Forest University Health Sciences.

NCT02426658 is a Phase 2 study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 16 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02426658, a Phase 2 study, has completed, sponsored by Wake Forest University Health Sciences.

COMPLETED
Registry status
Phase 2
Development phase
16 participants
Enrollment target

Study Summary

This pilot phase II trial studies how well pemetrexed disodium works in treating patients with stage IV non-small cell lung cancer and an Eastern Cooperative Oncology Group (ECOG) performance status of 3. Performance status means how well patients are able to perform daily activities and care for themselves. Patients with a performance status of 3 have a limited ability to move around. Currently, only patients who are able to perform most of their daily activities may receive chemotherapy, due to the side effects it may cause. Pemetrexed disodium causes fewer side effects than many chemotherapy drugs and may help treat patients with stage IV non-small cell lung cancer and a lower performance status.

Primary Outcome

Quality of life will be assessed at each treatment time (i.e. every three weeks). A longitudinal mixed models analysis will be used to look at QOL over the time course. A paired t-test will also be calculated to see if the average change is more than 0 (worsening) versus a two-sided alternative that the difference is 0 or better. Score range from 0-100 (1 = not at all, 2 = a little, 3 = quite a bit, or 4 = very much). The higher the score, the greater the change in the quality of life for the wo

Interventions

  • OTHER Quality-of-Life Assessment
  • OTHER Laboratory Biomarker Analysis
  • DRUG Pemetrexed Disodium

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2015-05
Est. Completion 2022-10-07
Phase Phase 2
Wake Forest University Health Sciences

1,140 total trials

What the finished NCT02426658 record still lists

NCT02426658 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower).

The record links to 0 conditions, and to 3 interventions - of which Quality-of-Life Assessment is the first listed.

NCT02426658 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02426658 about?

NCT02426658 is a clinical study titled "Pemetrexed Disodium in Treating Patients With Stage IV Non-small Cell Lung Cancer and ECOG Performance Status 3". This pilot phase II trial studies how well pemetrexed disodium works in treating patients with stage IV non-small cell lung cancer and an Eastern Cooperative Oncology Group (ECOG) performance status of 3. Performance status means how well patients are able to perform daily activities and care for th...

What is the current status of trial NCT02426658?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2015-05. Estimated completion is 2022-10-07.

What interventions are being tested in trial NCT02426658?

The interventions under investigation include: Quality-of-Life Assessment (OTHER), Laboratory Biomarker Analysis (OTHER), Pemetrexed Disodium (DRUG).

Who is sponsoring clinical trial NCT02426658?

This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02426658's enrollment target sits among peer trials

16 1908th of 2000 higher than 82 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT02426658, the US trial registry maintained by the National Library of Medicine. NCT02426658 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.