Clinical Trials Logo
  1. Home
  2. Non-Small-Cell Lung Carcinoma
  3. NCT03054038

Afatinib and Necitumumab in Patients With EGFR Mutation Positive Advanced or Metastatic Non-small Cell Lung Cancer

Non-Small Cell Lung Carcinoma Clinical Trial

Official title:
Phase I Trial of Combination Afatinib and Necitumumab in EGFR Mutation Positive NSCLC With Acquired Resistance to First or Third Generation EGFR TKIs

Clinical Trial Summary

This phase I trial studies the side effects and best dose of afatinib and necitumumab and to see how well they work in treating patients with EGFR mutation positive non-small cell lung cancer that has spread to other places in the body. Afatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as necitumumab, may interfere with the ability of tumor cells to grow and spread. Giving afatinib and necitumumab may work better in treating patients with EGFR mutation positive non-small cell lung cancer.

Clinical Trial Description

PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose of combination afatinib and necitumumab therapy in EGFR mutation positive non-small cell lung cancer (NSCLC) patients who have progressed following first- and third-generation EGFR tyrosine kinase inhibitors (TKIs). II. To determine the efficacy and safety profile of afatinib and necitumumab combination therapy in patients with EGFR mutation positive NSCLC patients who have progressed following first- and third-generation EGFR TKIs. OUTLINE: This is a dose-escalation study. Patients receive afatinib orally (PO) once daily (QD) on days 1-28 and necitumumab intravenously (IV) over 60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 28 days and then every 3 months for up to 1 year. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03054038
Study type Interventional
Source Vanderbilt-Ingram Cancer Center
Contact
Status Terminated
Phase Phase 1
Start date July 20, 2017
Completion date March 23, 2022
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05110196 - Study of Capmatinib in Indian Patients With MET Exon 14 Skipping Mutation Positive Advanced NSCLC. Phase 4
Completed NCT02795156 - Study Assessing Activity of Molecularly Matched Targeted Therapies in Select Tumor Types Based on Genomic Alterations Phase 2
Terminated NCT02556593 - IMRT Combined With Erlotinib for EGFR Wild Type Non-small Cell Lung Cancer With 4-10 Brain Metastases Phase 2
Active, not recruiting NCT03678350 - Light Dosimetry for Photodynamic Therapy With Porfimer Sodium in Treating Participants With Malignant Mesothelioma or Non-Small Cell Lung Cancer With Pleural Disease Undergoing Surgery Phase 1
Recruiting NCT05358249 - Platform Study of JDQ443 in Combinations in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation Phase 1/Phase 2
Recruiting NCT02273271 - Evaluation of FLT-PET and DWI-MRI in Patients With NSCLC Treated With a Platinum-based Doublet as Preoperative Chemo N/A
Withdrawn NCT03408561 - Social Media Listening in Improving Clinical Trial Recruitment in Patients With Cancer N/A
Active, not recruiting NCT04984811 - NT-I7 in Combination With Atezolizumab in Previously Untreated, PD-L1-expressing, Locally Advanced or Metastatic NSCLC Phase 2
Completed NCT02922777 - Trial of Dose Escalated BGB324 in Previously Treated Non-small Cell Lung Cancer. Phase 1
Active, not recruiting NCT01279408 - Observing Patients With Palliative Asymptomatic Centrally Located Advanced Non-small Cell Lung Carcinoma (NSCLC)
Completed NCT00081315 - Subcutaneous Amifostine (Ethyol®) in the Prevention of Radiochemotherapy-Induced Esophagitis and Pneumonitis in Patients With Unresectable Non-Small Cell Lung Cancer Phase 2
Active, not recruiting NCT03731585 - Online Psychosocial Intervention in Improving Social Well-Being and Support in Women With Stage I-IV Non-small Cell Lung Cancer Undergoing Treatment N/A
Active, not recruiting NCT02009449 - A Phase 1 Study of Pegilodecakin (LY3500518) in Participants With Advanced Solid Tumors Phase 1
Completed NCT00540514 - Albumin-bound Paclitaxel (ABI-007) for Patients With Advanced Non-Small Cell Lung Cancer Phase 3
Completed NCT03849469 - A Study of XmAb®22841 Monotherapy & in Combination w/ Pembrolizumab in Subjects w/ Selected Advanced Solid Tumors Phase 1
Recruiting NCT05642195 - Evaluation of a Cancer Lysate Vaccine and Montanide (Registered Trademark) ISA-51 VG With or Without the IL-15 Super-Agonist N-803 as Adjuvant Therapy for PD-L1 Negative Non-Small Cell Lung Cancer Phase 1/Phase 2
Completed NCT02848872 - Evaluation of Tumor and Blood Immune Biomarkers in Resected Non-small Cell Lung Cancer
Not yet recruiting NCT06222489 - Whole Body HER3 Quantification With Radiolabelled Patritumab Deruxtecan (HER3-DXd) PET/CT Phase 2
Active, not recruiting NCT03752398 - A Study of XmAb®23104 in Subjects With Selected Advanced Solid Tumors (DUET-3) Phase 1
Terminated NCT01288430 - A Study of DS-2248 in Participants With Advanced Solid Tumors Phase 1