NSCLC Clinical Trial
Official title:
A Randomized, Non-comparative, Multicenter, Open-Label, Phase 2 Study of Tarceva™ (Erlotinib) Alone and of Tarceva Plus VELCADE* (Bortezomib) for Injection in Patients With Relapsed or Refractory, Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Tarceva, an orally available small molecule, has demonstrated potent activity in tumor models and humans. This randomized, open-label phase 2 study of Tarceva alone and of Tarceva plus VELCADE is designed primarily to determine the objective tumor response rates to these treatments in patients with Stage IIIB or Stage IV non-small cell lung cancer (NSCLC) that is refractory to or has relapsed after front-line chemotherapy.
Status | Terminated |
Enrollment | 0 |
Est. completion date | August 2007 |
Est. primary completion date | July 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1)Relapsed or refractory, Stage IIIB or Stage IV NSCLC that has been histologially or cytologically confirmed. 2)One prior line of conventional cytotoxic chemotherapy. 3)Documented progressive disease(PD) during or since last prior therapy as determined by the investigator. 4)18 y/o or older. 5)Have measurable disease by RECIST. 6)Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 7)Life expectancy greater than 3 mo from the date of enrollment. 8)Female patient is either post-menopausal, surgically sterilized or willing to use an acceptable method of birth control. 9)Male pateint agrees to use an acceptable method of birth control during study treatment. 10)Provide written informed consent before the conduct of any study-related procedure. 11)Willing and able to comply with the protocol requirements. Exclusion Criteria: 1)Previous treatment w/VELCADE. 2)Pre-existing interstitial lung disease. 3)Peripheral neuropathy of Grade 2 or greater. 4)Diarrhea or vomiting greater than Grade 1 in intensity whether in the absence or presence of antidiarrheal and/or antiemetic therapy. 5)Chemotherapy, radiation therapy, treatment wtih monoclonal Antibodies, or major surgery w/in 4 wks prior to enrollment. 6)Documented greater than 10% WT loss in the 6 wks. prior to enrollment. 7)Inadequate organ function during screening as per laboratory values. 8)Myocardial infarction w/in 6 months prior to enrollment. 9)Brain metastases. 10)Any malignancy other than NSCLC occuring w/in 5 years of enrollment with the exception of basal cell carcinoma of the sin, and carcinoma in situ of the cervix. 11)Hx of allergic reaction to compounds containing boron or mannitol. 12)Known human immunodeficiency virus (HIV)+ or hepatitis B. 13)Poorly controlled hypertension, diabetes mellitus, or pyschiatric illness. 14)Pregnant or breast-feeding woman. Confirmation that patient is not pregnant must be established by a negative serum (B-hCG).15)Currently enrolled in another clinical research study or has received an investigational agent w/in 4 weeks prior to enrollment. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Tennesee | Knoxville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Millennium Pharmaceuticals, Inc. | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
United States,
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05821933 -
RC108 Combine With Furmonertinib With/Without Toripalimab in Patients With EGFR-mutated NSCLC
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03269162 -
Postoperative NSCLC Treated With Integrated Medicine Base on Circulating Tumor Cell Detection
|
Phase 3 | |
Recruiting |
NCT05002270 -
JAB-21822 Activity in Adult Patients With Advanced Solid Tumors Harboring KRAS G12C Mutation
|
Phase 1/Phase 2 | |
Recruiting |
NCT06315686 -
The Dynamic Monitoring of Cerebrospinal Fluid ctDNA
|
Phase 2 | |
Active, not recruiting |
NCT05059522 -
Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing
|
Phase 3 | |
Recruiting |
NCT05466149 -
Efficacy and Safety of Furmonertinib in Patients With Locally Advanced or Metastatic NSCLC With EGFR Exon 20 Insertion
|
Phase 2 | |
Recruiting |
NCT03175224 -
APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
|
Phase 2 | |
Completed |
NCT03609918 -
Comprehensive Analysis of Gene Mutation Profile in Chinese NSCLC Patients by Next-generation Sequencing
|
||
Recruiting |
NCT06043817 -
First-In-Human Study of STX-721 in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations
|
Phase 1/Phase 2 | |
Completed |
NCT03652077 -
A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies
|
Phase 1 | |
Recruiting |
NCT05078931 -
A Study to Evaluate Pembrolizumab Plus Lenvatinib in PD-L1 Positive TKI Resistant NSCLC Patients
|
Phase 2 | |
Not yet recruiting |
NCT05547737 -
Multicenter, Prospective, Real World Study of Camrelizumab in Cross-line Treatment of Non-small Cell Lung Cancer
|
||
Not yet recruiting |
NCT05909137 -
Omitting Clinical Target Volume in Radical Treatment of Unresectable Stage III Non-small Cell Lung Cancer
|
||
Withdrawn |
NCT05959473 -
EGFR_IUO 3.20 Clinical Study Protocol
|
N/A | |
Not yet recruiting |
NCT05005468 -
A Phase II Trial of Camrelizumab Combined With Famitinib for Adjuvant Treatment of Stage II-IIIA NSCLC.
|
Phase 2 | |
Recruiting |
NCT01690390 -
Dose Escalation of Icotinib in Advanced Non-small Cell Lung Carcinoma (NSCLC) Patients Evaluated as Stable Disease
|
Phase 2 | |
Completed |
NCT01852578 -
Cabazitaxel in Relapsed and Metastatic NSCLC
|
Phase 2 | |
Active, not recruiting |
NCT01460472 -
Immunotherapy With Racotumomab in Advanced Lung Cancer
|
Phase 3 | |
Completed |
NCT00702975 -
Study of Combination Therapy of Carboplatin -Gemcitabine Plus Bevacizumab Beyond Progression in Patients With Locally Advanced and/or Metastatic Non-small Cell Lung Cancer (NSCLC) Who Have Not Received Prior Systemic Therapy
|
Phase 2 | |
Completed |
NCT00866970 -
Safety, Efficacy and Pharmacokinetics of ALD518 in Patients With Non-Small Cell Lung Cancer-related Fatigue and Cachexia
|
Phase 2 |