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RECRUITING
NCT06421298
PHASE2

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.

Sponsor: Jinghui Wang

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2024-05-17

Completion Date

2027-05-30

Last Updated

2024-05-20

Healthy Volunteers

No

Conditions

Interventions

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

Locations (1)

Beijing Chest Hospital, Capital Medical University

Beijing, Beijing Municipality, China