Clinical Trials Logo
  1. Home
  2. Carcinoma, Non-Small-Cell Lung
  3. NCT00207116
  4. Details
NCT00207116 Clinical Trial

An Exploratory Pharmacogenomic Study of Monotherapy Erbitux in Subjects With Metastatic Non Small Cell Lung Carcinoma

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:
An Exploratory Pharmacogenomic Study of Monotherapy Erbitux in Subjects With Metastatic Non Small Cell Lung Carcinoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00207116
Other study ID # CA225-065
Secondary ID
Status Completed
Phase Phase 1
First received September 12, 2005
Last updated October 26, 2015
Start date September 2005
Est. completion date March 2006

Study information
Verified date October 2015
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to predict responses to Erbitux as a single agent in patients with Non Small Cell Lung Cancer

Other known NCT identifiers
  • NCT00118118

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date March 2006
Est. primary completion date March 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Measurable disease tumor available for biopsies

- Life expectancy of at least 3 months

Exclusion Criteria:

- Known or documented brain metastases prior to Cetuximab therapy

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Cetuximab
IV solution, IV, 400 mg/m2 initial dose followed by weekly doses of 250 mg/m2, Weekly, until disease progression.

Locations
Country Name City State
United States Local Institution Newark Delaware

Sponsors (1)
Lead Sponsor Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prediction of response to Erbitux with non small cell lung cancer
Secondary Radiographic Response
See also
  Status Clinical Trial Phase
Completed NCT04879849 - A Study of TAK-676 With Pembrolizumab After Radiation Therapy to Treat a Number of Cancers Phase 1
Completed NCT04426825 - A Study of Atezolizumab in Combination With Bevacizumab in Patients With EGFR Mutation Positive Stage IIIB-IV Non-Squamous Non-Small Cell Lung Cancer Phase 2
Terminated NCT03166631 - A Trial to Find the Safe Dose for BI 891065 Alone and in Combination With BI 754091 in Patients With Incurable Tumours or Tumours That Have Spread Phase 1
Completed NCT02810457 - Evaluation of FKB238 and Avastin in Patients With Advanced/Recurrent Non-squamous Non-small Cell Lung Cancer Phase 3
Completed NCT02864394 - Study of Pembrolizumab Versus Docetaxel in Participants Previously Treated for Non-Small Cell Lung Cancer (MK-3475-033/KEYNOTE-033) Phase 3
Recruiting NCT04592523 - A Study of Usage of Brigatinib in the Treatment of Adult Participants for Approved Indications In South Korea
Recruiting NCT04838548 - A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With EGFR-Positive Advanced Non-Small Cell Lung Cancer Phase 2
Recruiting NCT04077463 - A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer Phase 1
Recruiting NCT05167604 - Clinical Value of MRD Monitoring for Adjuvant Therapy in Postoperative NSCLC
Recruiting NCT04603807 - A Study to Compare the Efficacy and Safety of Entrectinib and Crizotinib in Participants With Advanced or Metastatic ROS1 Non-small Cell Lung Cancer (NSCLC) With and Without Central Nervous System (CNS) Metastases Phase 3
Completed NCT04948411 - Durvalumab as Maintenance in Patients Who Received Chemoradiotherapy for Unresectable Stage III NSCLC: Real World Data From an Expanded Access Program in Brazil
Active, not recruiting NCT04487080 - A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer Phase 3
Not yet recruiting NCT04255836 - Durvalumab Combined With Chemotherapy and Stereotactic Body Radiotherapy (SBRT) in Patients With Oligometastatic Non-small Cell Lung Cancer (NSCLC) Phase 2
Completed NCT01953913 - Afatinib (BIBW 2992) in Advanced Non-Small Cell Lung Cancer Patients With EGFR Mutation Phase 3
Recruiting NCT05715229 - Immune Profile Selection By Fraction of ctDNA in Patients With Advanced NSCLC Treated With Immunotherapy Phase 2
Recruiting NCT04931654 - A Study to Assess the Safety and Efficacy of AZD7789 in Participants With Advanced or Metastatic Solid Cancer Phase 1/Phase 2
Suspended NCT05421936 - Osimertinib for NSCLC With Uncommon EGFR Mutations
Completed NCT02847377 - A Positron Emission Tomography (PET) Imaging Agent [18F]-ODS2004436 as a Marker of EGFR Mutation in Subjects With NSCLC N/A
Completed NCT04427072 - Study of Capmatinib Efficacy in Comparison With Docetaxel in Previously Treated Participants With Non-small Cell Lung Cancer Harboring MET Exon 14 Skipping Mutation Phase 3
Recruiting NCT04823377 - Impact of a Process Optimizing the Decision to Continue or Stop Cancer Treatments in Patients With Advanced Non-small Cell Lung Cancer. N/A

External Links