Non-small Cell Lung Cancer (NSCLC) Clinical Trial
Official title:
Phase II Study of a Novel Taxane (Cabazitaxel-XRP6258) in Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC) Patients
Lung cancer is the leading cause of cancer death worldwide and in the United States. The majority of lung cancers are non-small cell lung cancer (NSCLC). The majority of NSCLC cases are advanced at the time of diagnosis. Chemotherapy has improved overall survival but remains limited at < 12 months median overall survival. New approaches are needed for second line chemotherapy treatment. Cabazitaxel-XRP6258 has shown increased overall survival in metastatic prostate cancer and it is hopeful it can do the same in advanced NSCLC.
A substantial number of patients with lung cancer progress after first line treatment and
require second line chemotherapy. Lung cancer appears to account for 40-50% of all known
brain metastasis. The incidence of brain metastases among lung cancer patients ranges from
16-20%. Chemotherapy has had limited utility due to problems crossing the blood brain
barrier.
Currently there are three drugs approved by the FDA for second line treatment of NSCLC but
each has distinct toxicities. Cabazitaxel-XRP6258 is a potent novel taxane with enhanced
activity against an increased number of cell lines including lung, prostate, colon,
pancreas, head and neck, kidney, gastric, glioblastoma, and melanoma. It also has the
ability to cross the blood brain barrier. Cabazitaxel-XRP6258 was found to have an improved
antiproliferative activity than other chemotherapy agents against insensitive cell lines.
The Phase I studies of Cabazitaxel-SRP6258 have determined dosage and schedule
recommendations in advanced NSCLC patients to be utilized for a Phase II multicenter study.
Subjects will be placed on one of two schedules (A or B) each with a specified dosage and
administration schedule. All subjects will be followed for survival/progression after every
2 cycles of therapy with imaging studies. A two stage design will be used for each of the
two schedules. Fourteen subjects will be accrued for each schedule in the first stage with
possible accrual of an additional 34 subjects per schedule depending upon the first stage
results.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06040541 -
Study of RMC-9805 in Participants With KRASG12D-Mutant Solid Tumors
|
Phase 1 | |
Recruiting |
NCT05107674 -
A Study of NX-1607 in Adults With Advanced Malignancies
|
Phase 1 | |
Active, not recruiting |
NCT03667820 -
Study of Osimertinib and Stereotactic Ablative Radiation (SABR) in EGFR Mutant NSCLC
|
Phase 2 | |
Completed |
NCT02025114 -
Selumetinib in Combination With Gefitinib in NSCLC Patients
|
Phase 1/Phase 2 | |
Recruiting |
NCT01994057 -
A Retrospective Study of EGFR-TKIs,Gefitinib, Erlotinib and Osimertinib in NSCLC Patients Treatment
|
||
Completed |
NCT01193959 -
Pemetrexed in Advanced Non-small Cell Lung Cancer
|
||
Recruiting |
NCT01028729 -
A Study of Endostar Combined With Chemotherapy Followed by Endostar Maintenance Therapy to Treat Advanced Non-small Cell Lung Cancer (NSCLC)
|
Phase 4 | |
Completed |
NCT00770588 -
Assess the Efficacy, Safety and Tolerability of Gefitinib (Iressa® 250mg) as Maintenance Therapy in Locally Advanced or Metastatic (Stage IIIB/IV) Non Small Cell Lung Cancer (NSCLC)
|
Phase 4 | |
Active, not recruiting |
NCT05462717 -
Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors
|
Phase 1 | |
Completed |
NCT01951157 -
A Clinical Study in Three-arm of Lurbinectedin (PM01183) Alone or in Combination With Gemcitabine and a Control Arm With Docetaxel as Second Line Treatment in Non-Small Cell Lung Cancer (NSCLC) Patients
|
Phase 2 | |
Recruiting |
NCT01964157 -
An Open-label, Multicenter, Phase II Study of LDK378 in Patients With Non-small Cell Lung Cancer Harboring ROS1 Rearrangement
|
Phase 2 | |
Active, not recruiting |
NCT04026412 -
A Study of Nivolumab and Ipilimumab in Untreated Participants With Stage 3 Non-small Cell Lung Cancer (NSCLC) That is Unable or Not Planned to be Removed by Surgery
|
Phase 3 | |
Recruiting |
NCT05585320 -
A Phase 1/2a Study of IMM-1-104 in Participants With Previously Treated, RAS-Mutant, Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT03260491 -
HER3-DXd in Metastatic or Unresectable Non-Small Cell Lung Cancer
|
Phase 1 | |
Completed |
NCT05207423 -
A Chart Review Study of Adults With Advanced NSCLC
|
||
Terminated |
NCT02608528 -
Serial [18F]Fluorodeoxyglucose ([18F]FDG )PET/CT as a Biomarker of Therapeutic Response in Anti-PD1/PDL1 Therapy
|
||
Completed |
NCT01463423 -
Individualized Lung Tumor Stereotactic Ablative Radiotherapy (iSABR)
|
N/A | |
Recruiting |
NCT02927340 -
A Study of Lorlatinib in Advanced ALK and ROS1 Rearranged Lung Cancer With CNS Metastasis in the Absence of Measurable Extracranial Lesions
|
Phase 2 | |
Recruiting |
NCT02521051 -
Phase I/II Trial of Alectinib and Bevacizumab in Patients With Advanced, Anaplastic Lymphoma Kinase (ALK)-Positive, Non-Small Cell Lung Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT02403193 -
Trial of PBF-509 and PDR001 in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
|
Phase 1 |