NSCLC Clinical Trial
Official title:
A Phase III, Multi Center, Randomized, Placebo Controlled Study to Evaluate the Efficacy of the Combination Gefitinib With Thalidomide in Patients With Locally Advanced and Metastatic Non-Small-Cell-Lung-Cancer With EGFR Mutation
The purpose of this study is to determine whether thalidomide can improve the effectiveness of the gefitinib in NSCLC patients with EGFR mutations.
Primary Objective:
To determine the 1 year progression-free survival(PFS) rate of the combination of
thalidomide with gefitinib in patients who harbors EGFR mutations.
Secondary Objectives:
1. To evaluate the objective response rate and 2 years overall survival of this
combination therapy;
2. To evaluate the safety and tolerability of this combination therapy;
3. To acquire preliminary data regarding the effects of thalidomide on interleukin-2 level
in serum.
Treatment will be administered on an outpatient basis. Thalidomide starting at a dose of
50mg QD at night. After one week, increase the dose to 100mg QD at night.
Aspirin will be administered at 100mg QD continuously. Gefitinib will be administered at
250mg QD continuously. Maintenance Therapy patients responding to this therapy will be
maintained with gefitinibăthalidomide and aspirin.
Duration of Therapy
In the absence of treatment delays due to adverse events, treatment may continue until one
of the following criteria applies:
1. Disease progression,
2. Intercurrent illness that prevents further administration of treatment,
3. Unacceptable adverse events(s),
4. Patient decides to withdraw from the study, or
5. General or specific changes in the patient's condition render the patient unacceptable
for further treatment in the judgment of the investigator.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| 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 |
NCT00866970 -
Safety, Efficacy and Pharmacokinetics of ALD518 in Patients With Non-Small Cell Lung Cancer-related Fatigue and Cachexia
|
Phase 2 | |
| 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 |