Non-small-cell Lung Cancer Clinical Trial
Official title:
A Phase I-II Clinical Study of Nimotuzumab (TheraCIM h-R3) in Combination With External Radiotherapy in Stage IIB, III and IV NSCLC
This is a Phase I-II study designed to investigate nimotuzumab (TheraCIM h-R3) in
combination with external radiation in patients with non-small cell lung cancer. The purpose
of the Phase I portion of the study is to evaluate the safety and feasibility of the
administration of nimotuzumab with palliative radiation in patients who are unsuitable for
radical therapy and to select the optimal dose for the Phase II component of the study. The
primary objective for the Phase II portion of the study is to examine the efficacy of this
combination treatment.
The Phase I component of this study has been completed. The Phase II is now closed to
recruitment.
This is a randomized, double blind, multicenter Phase II study with Phase I lead-in.
Patients enrolled in this study will receive external radiotherapy with or without
nimotuzumab (TheraCIM h-R3). The objective of the Phase I component of the study is to
evaluate the safety and feasibility of the administration of nimotuzumab with palliative
radiation in patients who are unsuitable for radical therapy (curative intent
chemoradiation) and to select the optimal biologically effective dose (BED) for Phase II
component of the study. In the Phase II component, overall survival, local and systemic
response rates and quality of life will be evaluated inpatients treated with nimotuzumab in
combination with palliative radiation vs. radiation alone.
The Phase I component of this study has been completed. The Phase II is now closed to
recruitment.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT02495233 -
A Study of ASP2215 in Combination With Erlotinib in Subjects With Epidermal Growth Factor Receptor (EGFR) Activating Mutation-Positive (EGFRm+) Advanced Non-Small-Cell Lung Cancer (NSCLC) Who Have Acquired Resistance to an EGFR Tyrosine Kinase Inhibitor (TKI)
|
Phase 1/Phase 2 | |
Withdrawn |
NCT02672358 -
Study of Efficacy and Safety of Dabrafenib and Trametinib Combination Therapy in Japanese Patients With BRAF V600E Stage IV NSCLC
|
Phase 2 | |
Recruiting |
NCT05815472 -
Advanced Patient Monitoring and A.I. Supported Outcomes Assessment in Lung Cancer Using Internet of Things Technologies (A.I. - APALITT)
|
N/A | |
Not yet recruiting |
NCT05900219 -
Efficacy and Safety of HL-085 Combined With Vemurafenib in BRAF V600E Patients With Non-small Cell Lung Cancer: a Phase II Clinical Study
|
Phase 2 | |
Not yet recruiting |
NCT04560244 -
A Trial of SHR1701 Combined With Radiotherapy for Metastatic Non-small Cell Lung Cancer Failure After First-line Treatment
|
Phase 2 | |
Not yet recruiting |
NCT02907606 -
Urinary Circulating Tumor DNA Detection in Non-small Cell Lung Cancer: a Prospective Study
|
N/A | |
Completed |
NCT01924416 -
Lung Cancer Information Study (LCIS-R01)
|
N/A | |
Completed |
NCT01136083 -
Effect of Exercise Training on Angiogenesis and Cachexia in Lung Cancer Patients
|
N/A | |
Completed |
NCT00831454 -
Identification of EGFR-TKIs Sensitivity or Resistance Markers in NSCLC May Help in Optimal Patient Selection
|
N/A | |
Completed |
NCT00363766 -
Study of LY573636-Sodium in Patients With Metastatic Non-Small Cell Lung Cancer
|
Phase 2 | |
Completed |
NCT00913705 -
Neoadjuvant or Adjuvant Chemotherapy in Patients With Operable Non-small-cell Lung Cancer
|
Phase 3 | |
Completed |
NCT01383135 -
Biodistribution and Safety of the PET Probes [18F]FPRGD2 and [18F]FPPRGD2
|
Early Phase 1 | |
Completed |
NCT01124864 -
A Study of AUY922 in Non-small-cell Lung Cancer Patients Who Have Received Previous Two Lines of Chemotherapy.
|
Phase 2 | |
Completed |
NCT00049998 -
Oral Topotecan Versus Intravenous Docetaxel In Pretreated, Advanced Non-Small Cell Lung Cancer
|
Phase 3 | |
Terminated |
NCT05061537 -
Study of PF-07263689 in Participants With Selected Advanced Solid Tumors
|
Phase 1 | |
Completed |
NCT03320044 -
Early Diagnosis of Small Pulmonary Nodules by Multi-omics Sequencing
|
||
Recruiting |
NCT04895930 -
Furmonertinib Combined With Anlotinib as the First-line Treatment in Patients With EGFR Mutation-positive NSCLC
|
Phase 2 | |
Recruiting |
NCT03267654 -
Gefitinib With Chemotherapy or Anti-angiogenesis in NSCLC Patients With Bim Deletion or Low EGFR Mutation Abundance
|
Phase 2 | |
Recruiting |
NCT04401059 -
Synergistic Effect of Elemene Plus TKIs Compared With TKIs in EGFR-mutated Advanced NSCLC:Prospective Study
|
Phase 4 | |
Completed |
NCT02965391 -
Dynamic Changes of Circulating Tumor DNA in Surgical Lung Cancer Patients
|