Clinical Trials Logo

Clinical Trial Summary

This is an open label, phase II study in which cetuximab with concurrent thoracic radiotherapy followed by consolidation chemotherapy with paclitaxel/carboplatin/cetuximab will be administered to subjects with locally advanced NSCLC.


Clinical Trial Description

This is a Phase II study to determine the overall survival for patients with locally advanced NSCLC treated with cetuximab with concurrent thoracic radiotherapy followed by consolidation chemotherapy with paclitaxel/carboplatin/cetuximab. This is a multicenter study including 36 subjects who will be males and females, both greater than 18 years of age. All subjects will initially receive radiation and cetuximab. Radiation will be given once a day (Monday-Friday) for approximately 6-8 weeks. During the course of radiation, cetuximab will be given intravenously once a week. Approximately 4-6 weeks after the last radiation dose, the subjects will be treated with chemotherapy, paclitaxel/carboplatin. Chemotherapy will be given intravenously once every 3 weeks for 3 cycles (1 cycle=3 weeks). Cetuximab intravenous administration will be continued throughout the entire study, once a week through week 26 including during chemotherapy. ;


Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00492206
Study type Interventional
Source University of Pittsburgh
Contact
Status Completed
Phase Phase 2
Start date June 2006
Completion date February 2012

See also
  Status Clinical Trial Phase
Completed NCT01204099 - Study of PX-866 and Docetaxel in Solid Tumors Phase 1/Phase 2
Recruiting NCT04083599 - GEN1042 Safety Trial and Anti-tumor Activity in Subjects With Malignant Solid Tumors Phase 1/Phase 2
Completed NCT00148798 - Study of Cisplatin/Vinorelbine +/- Cetuximab as First-line Treatment of Advanced Non Small Cell Lung Cancer (FLEX) Phase 3
Recruiting NCT06026410 - KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors Phase 1
Completed NCT02988817 - Enapotamab Vedotin (HuMax-AXL-ADC) Safety Study in Patients With Solid Tumors Phase 1/Phase 2
Completed NCT01005797 - Study of Panobinostat in Combination With Sorafenib in Kidney, Soft Tissue or Lung Cancers Phase 1
Recruiting NCT00637910 - Tarceva Italian Lung Optimization tRial Phase 3
Active, not recruiting NCT03447678 - Pembrolizumab in First Line Treatment of Advanced NSCLC Patients With PD-L1 Low Tumors. Phase 2
Completed NCT02456246 - Piloting the Feasibility of FLT-PET/CT Non-Small Cell Lung Cancer Managed With SBRT N/A
Completed NCT02014324 - Single Scope Staging of Lung Cancer With Endosonography N/A
Terminated NCT01741155 - Study of SPI-1620 in Combination With Docetaxel Versus Docetaxel Alone for Patients With Non Small-cell Lung Cancer (NSCLC) Phase 2
Completed NCT01594398 - Study to Assess Food Effect on Pharmacokinetics of Entinostat in Subjects With Breast Cancer or Non-Small Cell Lung Cancer Phase 1
Completed NCT01323062 - Bavituximab Plus Carbo and Pemetrexed in Chemo-Naive Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Subjects Phase 1
Active, not recruiting NCT04772989 - A Study to Evaluate AB308 in Combination With AB122 in Participants With Advanced Malignancies Phase 1
Completed NCT01702844 - Single Arm on the Tolerability of Weekly Nab-paclitaxel Phase 2
Completed NCT00820417 - Pharmocokinetic/Pharmacodynamic (PK/PD) Study of the Combination Cetuximab/Gefitinib Phase 1
Completed NCT02639026 - Trial Of Hypofractionated Radiotherapy In Combination With MEDI4736 And Tremelimumab For Patients With Metastatic Melanoma And Lung, Breast And Pancreatic Cancers Phase 1
Completed NCT01282437 - Prophylactic Cranial Irradiation (PCI) vs Observation in Stage III NSCLC Phase 3
Active, not recruiting NCT04721015 - Study of Intravenous (IV) ABBV-637 Alone or in Combination With IV Docetaxel/Osimertinib to Assess Adverse Events and Change in Disease Activity in Adult Participants With Relapsed/Refractory (R/R) Solid Tumors Phase 1
Not yet recruiting NCT05473156 - A Study to Investigate the Safety, Pharmacokinetics, and Clinical Activity of AP203 in Patients With Locally Advanced or Metastatic Solid Tumors, and Expansion to Selected Malignancies Phase 1/Phase 2