Clinical Trials Logo

Clinical Trial Summary

This study will investigate the efficacy and safety of the combination of pembrolizumab and lenvatinib in PD-L1 positive patients with TKI-resistant EGFR-mutated advanced NSCLC.


Clinical Trial Description

Tyrosine Kinase Inhibitors (TKIs) are the standard front-line treatment for patients with EGFR sensitive mutations. Even though patients have a better response rate and longer PFS comparing to chemotherapy, drug resistance have been an inevitable issue associated with these drugs. The standard of subsequent treatment for TKI resistance at present is chemotherapy (platinum doublet chemotherapy), which shows limited benefit with ORR 20-30% and PFS nearly 4 months. Therefore, it is essential to develop the novel therapies. Immune checkpoint therapy, which is based on negative regulatory mechanisms and targeted enhancement of the anti-tumor immune response, is a novel and important therapeutic strategy for lung cancer, especially for those patients with PD-1/PD-L1 positive advanced NSCLC. VEGF signaling regulates immune suppression by promoting the expansion of suppressive immune cell populations. Therefore, modulation of VEGF-mediated immune suppression could potentially augment the immunotherapeutic activity of immune checkpoint inhibitors. Lenvatinib is a multitargeted TKI with anti-tumor activity via inhibiting VEGFR 1-3, FGFR 1-4 and PDGFR. It modulates the cancer immunity associated with a decrease in the population of immunosuppressive tumor-associated macrophages and an increase in interferon-γ-producing CD8+ T cells. The combination of immune check point inhibitors (PD-1/PD-L1 inhibitors) and lenvatinib could be a promising strategy to improve the immunotherapy outcome in lung cancer patients. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05078931
Study type Interventional
Source Shanghai Chest Hospital
Contact Ziming Li
Phone +8613764590226
Email liziming1980@163.com
Status Recruiting
Phase Phase 2
Start date September 23, 2021
Completion date May 2024

See also
  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
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
Withdrawn NCT00576225 - CT-2103/Carboplatin vs Paclitaxel/Carboplatin for NSCLC in Women With Estradiol > 25 pg/mL Phase 3