Non Small Cell Lung Cancer (NSCLC) Clinical Trial
Official title:
Complete Endosonographic Staging of Lung Cancer: a Systematic Single Scope Approach
Rationale: Lung cancer is the most commonly diagnosed cancer worldwide and is the most
frequent cause of cancer death. Accurate staging is important because it directs treatment
and prognosis. Mediastinal staging can be done by both EBUS-TBNA and EUS-FNA. These two
techniques have a complementary diagnostic range and the combined procedure is suited for
assessment of almost the entire mediastinum. In practice, when mediastinal tissue staging is
indicated, endoscopists often perform either an EBUS or an EUS investigation (instead of the
combined procedure). Second, frequently only one or two, by imaging suspected lymph node
stations, are sampled (ie. targeted approach).
Objectives: main and secondary:
1. Complete endosonographic (combined endobronchial and esophageal) staging using a single
EBUS scope improves locoregional staging (N2, N3, T4) versus EBUS staging alone.
2. Systematic mediastinal staging results in improved locoregional staging compared to
PET-CT directed assessment of the mediastinum (ie targeted approach).
Study population: Patients with potentially operable and resectable NSCLC are eligible if
there is an indication for mediastinal nodal sampling. Patients have an indication for
EBUS-TBNA.
Intervention: Patients will undergo an EBUS investigation followed by EUS-B in the same
session. During this single scope procedure, lymph nodes that are suspected on prior CT-PET
imaging and on subsequent ultrasound are sampled.
Main study endpoint: The main study parameter is the sensitivity for locoregional disease
(N2, N3, T4 disease) of complete endosonographic staging (by EBUS-TBNA and EUS-B-FNA) in
comparison with EBUS staging alone.
n/a
Observational Model: Cohort, Time Perspective: Prospective
| 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 | |
| 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 |
NCT00492206 -
Study of Cetuximab With Radiation Followed by Consolidation Chemotherapy for NSCLC
|
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 |