Metastatic Non-Small Cell Lung Cancer Clinical Trial
Official title:
A Randomized, Phase II, Double-Blind Study of Nimotuzumab Plus Whole-Brain Radiation Therapy (WBRT) Compared With WBRT Alone in Patients With Brain Metastases From Non-Small Cell Lung Cancer
This is a randomized, Phase II study designed to investigate Nimotuzumab plus whole-brain radiation therapy (WBRT)and to compare it rith WBRT alone in patients with brain metastases from non-small cell lung cancer (NSCLC). The purpose of the study is to assess the efficacy of nimotuzumab in combination with WBRT.
A phase II, randomized, controlled, double blinded and multicenter study with 2 arms,
administering the study drug during radiotherapy and following radiotherapy until disease
progression, unacceptable toxicity or at the discretion of the physician. Randomization will
be done 2:1 (experimental:control). Chemotherapy can be added before documented disease
progression at the discretion of the physician.
The primary objective is to assess the efficacy of Nimotuzumab in combination with WBRT. The
primary endpoint is intracranial disease progression over 6 months.
The secondary endpoints are overall survival (OS); time to neurologic progression (TNP) or
death with evidence of neurologic progression; OS rate at 6 months; time to intracranial
disease progression; and time to overall progression.
Tissue samples and serum will be collected for future correlative studies.
All the images will be centrally reviewed at the end of study.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02857270 -
A Study of LY3214996 Administered Alone or in Combination With Other Agents in Participants With Advanced/Metastatic Cancer
|
Phase 1 | |
| Not yet recruiting |
NCT05985330 -
Pilot Study of the Contribution of Fractional Exhaled Nitric Oxide as a Prognostic Marker of Response to Anti-PD-L1 Immunotherapy in Non-small Cell Lung Cancer
|
||
| Recruiting |
NCT05013450 -
Dupilumab_Metastatic NSCLC
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05984277 -
A Global Study of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for Participants With Metastatic Non-small Cell Lung Cancer.
|
Phase 3 | |
| Completed |
NCT03215810 -
Nivolumab and Tumor Infiltrating Lymphocytes (TIL) in Advanced Non-Small Cell Lung Cancer
|
Phase 1 | |
| Completed |
NCT05675683 -
Real-World Assessment of Clinical Outcomes in Metastatic NSCLC Patients With MET Exon 14 Skipping Mutation and Brain Metastases Treated With Capmatinib
|
||
| Active, not recruiting |
NCT02411448 -
A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Previously Untreated Participants With EGFR Mutation-Positive Metastatic NSCLC (RELAY)
|
Phase 3 | |
| Recruiting |
NCT04410796 -
Osimertinib Alone or With Chemotherapy for EGFR-Mutant Lung Cancers
|
Phase 2 | |
| Recruiting |
NCT06343402 -
Study of BBO-8520 in Adult Subjects With KRASG12C Non-small Cell Lung Cancer
|
Phase 1 | |
| Recruiting |
NCT03300115 -
Clinical Trial of the Efficacy and Safety of AC0010 in the Treatment of EGFR T790M Patients With Advanded NSCLC
|
Phase 2 | |
| Recruiting |
NCT05635708 -
A Study of Tislelizumab in Combination With Investigational Agents in Participants With Non-Small Cell Lung Cancer
|
Phase 2 | |
| Terminated |
NCT03265080 -
A Study of ADXS-NEO Expressing Personalized Tumor Antigens
|
Phase 1 | |
| Active, not recruiting |
NCT05226598 -
Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination With Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007)
|
Phase 3 | |
| Withdrawn |
NCT02639234 -
Vigil™ + Nivolumab in Advanced Non-Small Cell Lung Cancer
|
Phase 2 | |
| Recruiting |
NCT05364073 -
Study of Furmonertinib in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Activating, Including Uncommon, Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) Mutations
|
Phase 1 | |
| Completed |
NCT03926260 -
Early Assessment of Response to Treatment of Metastatic LUng Tumors Based on CIrculating Tumor DNA
|
N/A | |
| Active, not recruiting |
NCT03976375 -
Efficacy and Safety of Pembrolizumab (MK-3475) With Lenvatinib (E7080/MK-7902) vs. Docetaxel in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) and Progressive Disease (PD) After Platinum Doublet Chemotherapy and Immunotherapy (MK-7902-008/E7080-G000-316/LEAP-008)
|
Phase 3 | |
| Recruiting |
NCT05546905 -
A Study in Patients With BRAF V600E-mutant Metastatic Non-small Cell Lung Cancer (OCTOPUS)
|
||
| Withdrawn |
NCT01936961 -
Study of Immunochemotherapy +/- Hypofractionated Radiation for Complete Response in Solid Tumors
|
N/A | |
| Not yet recruiting |
NCT06428422 -
The Impact of Probiotic on Survival and Treatment Response in Metastatic Non-small Cell Lung Cancer Patients
|
N/A |