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NCT00777309 · ClinicalTrials.gov registry record · Phase 2

A Randomized Phase 2 Study of Erlotinib + ARQ 197 Versus Erlotinib + Placebo in Previously Treated Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

A Phase 2 study of Non-Small Cell Lung Cancer, sponsored by ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA).

Completed
Registry status
Phase 2
Development phase
167
Enrollment target
20
Study locations

NCT00777309: Completed Phase 2 study of Non-Small Cell Lung Cancer, sponsored by ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA).

NCT00777309 is a Phase 2 study of Non-Small Cell Lung Cancer that has completed, run by ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA). The registered enrollment target is 167 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (74% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00777309, a Phase 2 study of Non-Small Cell Lung Cancer, has completed, sponsored by ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA).

COMPLETED
Registry status
Phase 2
Development phase
167 participants
Enrollment target
20
Study locations

Study Summary

This is a randomized, placebo-controlled, double blind phase 2 study designed to compare treatment with ARQ 197 plus erlotinib to erlotinib plus placebo in patients with non-small cell lung cancer. The study will enroll patients who have had one prior chemotherapy regimen (other than erlotinib) for NSCLC.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Erlotinib
  • DRUG ARQ 197

Study Locations (20)

Texas

  • - Corpus Christi
  • - Dallas
  • - Dallas
  • - Houston

California

  • - Burbank
  • - Santa Monica

Indiana

  • - Batesville
  • - Indianapolis

Massachusetts

  • - Boston
  • - Worcester

Other

  • - Gauting
  • - Großhansdorf

Connecticut

  • - Torrington

Florida

  • - Jacksonville

Georgia

  • - Atlanta

Trial Details

FieldValue
Enrollment Target 167 participants
Start Date 2008-09
Est. Completion 2011-08
Phase Phase 2

What the finished NCT00777309 record still lists

NCT00777309 is an interventional study that assigns participants to a tested intervention. The registered 167 participants enrollment target is mid-sized for trials with a published cap, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (74% lower).

The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT00777309 names 20 study sites across 13 states, led by Texas, California, Indiana.

Frequently Asked Questions

What is clinical trial NCT00777309 about?

NCT00777309 is a clinical study titled "A Randomized Phase 2 Study of Erlotinib + ARQ 197 Versus Erlotinib + Placebo in Previously Treated Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)". This is a randomized, placebo-controlled, double blind phase 2 study designed to compare treatment with ARQ 197 plus erlotinib to erlotinib plus placebo in patients with non-small cell lung cancer. The study will enroll patients who have had one prior chemotherapy regimen (other than erlotinib) for ...

What is the current status of trial NCT00777309?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 167 participants. The study started on 2008-09. Estimated completion is 2011-08.

What conditions does trial NCT00777309 study?

This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.

What interventions are being tested in trial NCT00777309?

The interventions under investigation include: Placebo (DRUG), Erlotinib (DRUG), ARQ 197 (DRUG).

Who is sponsoring clinical trial NCT00777309?

This trial is sponsored by ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA), which has 27 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00777309 being conducted?

This trial has 20 study locations across California, Connecticut, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Non-Small Cell Lung Cancer

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 NCT00777309's enrollment target sits among peer trials

167 186th of 454 higher than 269 of 454 other Non-Small Cell Lung Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer 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 NCT00777309, the US trial registry maintained by the National Library of Medicine. NCT00777309 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.