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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.

NCT06421298 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-05-20

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Jinghui Wang

    lead OTHER

Principal Investigators

  • Beijing C Beijing Chest Hospital · Employment relationship

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-17
Primary Completion
2027-05-30
Completion
2027-05-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06421298 on ClinicalTrials.gov