NCT06421298

A Prospective, Single-arm, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Tafolecimab and Sintilimab Combined With Chemotherapy in Patients With Advanced or Metastatic Driver Gene-negative Non-small Cell Lung Cancer After Failure of First-line Immunotherapy.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Jinghui Wang · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The second-line treatment for patients who have progressed after first-line immune checkpoint inhibitor therapy, is chemotherapy based on docetaxel and other drugs. The treatment effect is limited. The median survival time of them are 6 months. So there is a huge unmet medical need. This study is a Prospective, Single-arm, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Tafolecimab and Sintilimab Combined With Chemotherapy in Patients With Advanced or Metastatic Driver Gene-negative Non-small Cell Lung Cancer After Failure of First-line Immunotherapy. 30 patients will be enrolled. The main endpoint is PFS，and the secondary endpoint are OS,DCR,DOR,ORR, and so on.

Detailed description

This is a Prospective, Single-arm, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Tafolecimab and Sintilimab Combined With Chemotherapy in Patients With Advanced or Metastatic Driver Gene-negative Non-small Cell Lung Cancer After Failure of First-line Immunotherapy. 30 patients will be enrolled. These patients will be treated with chemotherapy combined with sintilimab and Tafolecimab. The main endpoint is PFS，and the secondary endpoint are OS,DCR,DOR,ORR, and so on.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	Tafolecimab	450mg Q4W ≤6cycle
DRUG	Sintilimab	200mg Q3W ≤2years
DRUG	Nab paclitaxel	130mg/m² Q3W 4-6cycles
DRUG	Docetaxel	75mg/m² Q3W 4-6cycles
DRUG	Gemcitabine	1250mg/m² Q3W 4-6cycles

Timeline

• Start date: 2024-05-17
• Primary completion: 2027-05-30
• Completion: 2027-05-30
• First posted: 2024-05-20
• Last updated: 2024-05-20

Locations

1 site across 1 country: China