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NCT01788566 · ClinicalTrials.gov registry record · Phase 2

A Study of Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab in the First-Line Treatment of Participants With Squamous Lung Cancer

A Phase 2 study, sponsored by Eli Lilly and Company.

Completed
Registry status
Phase 2
Development phase
61
Enrollment target

NCT01788566: Completed Phase 2 study, sponsored by Eli Lilly and Company.

NCT01788566 is a Phase 2 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 61 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01788566, a Phase 2 study, has completed, sponsored by Eli Lilly and Company.

COMPLETED
Registry status
Phase 2
Development phase
61 participants
Enrollment target

Study Summary

The purpose of this study is to see how participants with late stage lung cancer do on gemcitabine-cisplatin chemotherapy plus necitumumab. The study will also see how safe the drugs are in combination and to see how long the medicine stays in the body. The study will last approximately 2 years.

Primary Outcome

ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.1, PR defined as a \>30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD; CR was defined as the disappearance of all target and non-target lesions. Percentage of participants was calculated as: total number of participants with a best tumor response of PR or CR among participants counted in the denominator/total number of participants treated wi

Interventions

  • DRUG Cisplatin
  • DRUG Gemcitabine
  • DRUG Necitumumab

Trial Details

FieldValue
Enrollment Target 61 participants
Start Date 2013-03
Est. Completion 2015-12
Phase Phase 2
Eli Lilly and Company

1,341 total trials

What the finished NCT01788566 record still lists

NCT01788566 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% lower).

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

NCT01788566 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01788566 about?

NCT01788566 is a clinical study titled "A Study of Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab in the First-Line Treatment of Participants With Squamous Lung Cancer". The purpose of this study is to see how participants with late stage lung cancer do on gemcitabine-cisplatin chemotherapy plus necitumumab. The study will also see how safe the drugs are in combination and to see how long the medicine stays in the body. The study will last approximately 2 years.

What is the current status of trial NCT01788566?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 61 participants. The study started on 2013-03. Estimated completion is 2015-12.

What interventions are being tested in trial NCT01788566?

The interventions under investigation include: Cisplatin (DRUG), Gemcitabine (DRUG), Necitumumab (DRUG).

Who is sponsoring clinical trial NCT01788566?

This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01788566's enrollment target sits among peer trials

61 1026th of 2000 higher than 974 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 NCT01788566, the US trial registry maintained by the National Library of Medicine. NCT01788566 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.