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)

ClinicalTrials.gov ID: NCT00777309

Public ClinicalTrials.gov record NCT00777309. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 5, 2026, 10:32 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT00777309
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2
Lead sponsor: ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA); Industry
Enrollment: 167 participants

Conditions and interventions

Conditions

Non Small Cell Lung Cancer

Interventions

ARQ 197 Drug
Erlotinib Drug
Placebo Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Aug 31, 2008
Primary completion: Apr 30, 2011
Completion: Jul 31, 2011
Last update posted: Feb 27, 2013

2008 – 2011

United States locations

U.S. sites: 18
U.S. states: 12
U.S. cities: 17

Facility	City	State	ZIP	Site status
Not listed	Burbank	California	91505	—
Not listed	Santa Monica	California	90404	—
Not listed	Torrington	Connecticut	06790	—
Not listed	Jacksonville	Florida	32204	—
Not listed	Atlanta	Georgia	30309	—
Not listed	Chicago	Illinois	60612	—
Not listed	Batesville	Indiana	47006	—
Not listed	Indianapolis	Indiana	46107	—
Not listed	Louisville	Kentucky	40202	—
Not listed	Boston	Massachusetts	02114	—
Not listed	Worcester	Massachusetts	01608	—
Not listed	Charlotte	North Carolina	28204	—
Not listed	Canton	Ohio	44718	—
Not listed	Corpus Christi	Texas	78410	—
Not listed	Dallas	Texas	75246	—
Not listed	Dallas	Texas	75390	—
Not listed	Houston	Texas	77024	—
Not listed	Salt Lake City	Utah	84114	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 20 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00777309, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Feb 27, 2013 · Synced Sep 5, 2026

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The complete protocol, eligibility criteria, and contact information for NCT00777309 live on ClinicalTrials.gov.

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