Actively Recruiting
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.
Led by Jinghui Wang · Updated on 2024-05-20
30
Participants Needed
1
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent
- Age between 18 and 75 years old
- Life expectancy of at least 3 months
- Histologically or cytologically confirmed locally advanced (IIIB-IIIC), metastatic, or recurrent (Stage IV) NSCLC
- Disease relapse or progression after multimodal therapy including radiotherapy, surgery, or chemoradiotherapy
- Previous treatment with PD-1 or PD-L1 inhibitors with disease progression
- No EGFR, ALK, or other driver mutations
- At least one measurable lesion by RECIST v1.1 criteria
- Stable or controlled brain metastases allowed
- ECOG performance status 0-1
- Adequate organ function based on specified laboratory values
- Negative pregnancy test for women of childbearing potential within 3 days before first dose
- Use of effective contraception during treatment and for up to 120 days after last dose
- Ability to comply with study requirements as determined by the investigator
You will not qualify if you...
- Diagnosis of small cell lung cancer (SCLC) or mixed SCLC and NSCLC
- Received systemic anti-tumor treatment within 3 weeks prior to study treatment
- Received investigational drug within 4 weeks prior to study treatment
- Use of high-dose immunosuppressive drugs within 4 weeks prior to study treatment
- Received live attenuated vaccines within 4 weeks prior to study treatment or planned during study
- Major surgery within 4 weeks prior to study treatment or unhealed wounds
- Clinically uncontrolled pleural or abdominal effusion
- Chest radiation therapy >30Gy within 6 months prior or palliative radiation ≤30Gy within 7 days prior to treatment (except allowed bone or brain palliative radiation)
- Active autoimmune disease requiring systemic treatment within 2 years prior to first dose
- Known allogeneic organ or stem cell transplant
- Allergy to Tafolecimab or its components
- Not fully recovered from toxicity or complications of previous therapies
- Known HIV infection
- Untreated active hepatitis B or C infection
- Received live vaccine within 30 days before first dose (except inactivated influenza vaccine)
- Pregnant or breastfeeding women
AI-Screening
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Trial Site Locations
Total: 1 location
1
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
J
Jinghui Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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