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NCT06421298Recruiting

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.

Jinghui WangPhase 2ClinicalTrials.govdrug
Study focus
Disease/Condition
Lung Cancer
Drug/Device/Intervention
Tafolecimab
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Jinghui Wang
Funder
Beijing Chest Hospital, Capital Medical University
Location
Beijing, China
Timeline & enrollment
Phase
Phase 2
Start date
May 17, 2024
End date
May 30, 2027
Enrollment
30 participants
Primary outcome

PFS

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.

ICD-10 classifications
Carcinoma in situ: Bronchus and lungSecondary malignant neoplasm of lungMalignant neoplasm of bronchus and lungMalignant neoplasm: Bronchus or lung, unspecifiedMalignant neoplasm: Overlapping lesion of bronchus and lung
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06421298
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06421298 through Pure Global AI's free database. This Phase 2 trial is sponsored by Jinghui Wang and is currently Recruiting. The study focuses on Lung Cancer. Target enrollment is 30 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.