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NCT01519804 · ClinicalTrials.gov registry record · Phase 2

A Study of Onartuzumab (MetMAb) Versus Placebo in Combination With Paclitaxel Plus Platinum in Patients With Squamous Non-Small Cell Lung Cancer

A Phase 2 study, sponsored by Genentech.

Completed
Registry status
Phase 2
Development phase
108
Enrollment target

NCT01519804: Completed Phase 2 study, sponsored by Genentech.

NCT01519804 is a Phase 2 study that has completed, run by Genentech. The registered enrollment target is 108 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (19% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01519804, a Phase 2 study, has completed, sponsored by Genentech.

COMPLETED
Registry status
Phase 2
Development phase
108 participants
Enrollment target

Study Summary

This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with paclitaxel plus platinum in patients with incurable Stage IIIB or Stage IV squamous non-small cell lung cancer (NSCLC). Patients will be randomized to receive either onartuzumab (MetMAb) 15 mg/kg iv or placebo on Day 1 of each 21-day cycle in combination with 4 cycles of paclitaxel 200 mg/m2 iv and platinum (carboplatin/cisplatin) iv on Day 1 of each 21-day cycle. Patients who have not progressed after 4 cycles will continue with either onartuzumab (MetMAb) or placebo as maintenance therapy until disease progression or unacceptable toxicity occurs.

Interventions

  • DRUG Placebo
  • DRUG paclitaxel
  • DRUG onartuzumab
  • DRUG cisplatin/carboplatin

Trial Details

FieldValue
Enrollment Target 108 participants
Start Date 2012-04
Est. Completion 2015-09
Phase Phase 2
Genentech

332 total trials

What the finished NCT01519804 record still lists

NCT01519804 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (19% lower).

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT01519804 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01519804 about?

NCT01519804 is a clinical study titled "A Study of Onartuzumab (MetMAb) Versus Placebo in Combination With Paclitaxel Plus Platinum in Patients With Squamous Non-Small Cell Lung Cancer". This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with paclitaxel plus platinum in patients with incurable Stage IIIB or Stage IV squamous non-small cell lung cancer (NSCLC). Patients will be randomized t...

What is the current status of trial NCT01519804?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 108 participants. The study started on 2012-04. Estimated completion is 2015-09.

What interventions are being tested in trial NCT01519804?

The interventions under investigation include: Placebo (DRUG), paclitaxel (DRUG), onartuzumab (DRUG), cisplatin/carboplatin (DRUG).

Who is sponsoring clinical trial NCT01519804?

This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01519804's enrollment target sits among peer trials

108 640th of 2000 higher than 1,355 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 NCT01519804, the US trial registry maintained by the National Library of Medicine. NCT01519804 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.