OncoMatch/Clinical Trials/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.
Is NCT06421298 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments for lung cancer.
Treatment: Tafolecimab · Sintilimab · Nab paclitaxel · Docetaxel · Gemcitabine — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Chemotherapy
Other
Cancer type
Non-Small Cell Lung Carcinoma
Small Cell Lung Cancer
Biomarker criteria
Required: ALK wild-type
Required: EGFR wild-type
Disease stage
Required: Stage IIIB, IIIC, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: anti-PD-1 therapy
Patients must have previously used PD-1 or PD-L1 inhibitors and have disease progression
Must have received: anti-PD-L1 therapy
Patients must have previously used PD-1 or PD-L1 inhibitors and have disease progression
Cannot have received: systemic anti-tumor treatment
Exception: within 3 weeks before treatment
Received systemic anti-tumor treatment within 3 weeks before treatment, such as chemotherapy, targeted therapy, immunotherapy (including Chinese herbal treatment with anti-tumor indications), etc.
Cannot have received: investigational drug
Exception: within 4 weeks before treatment
Have received any investigational drug treatment within 4 weeks before treatment
Lab requirements
Blood counts
ANC ≥1.5x10^9/L without G-CSF in past 14 days; platelets ≥100×10^9/L without transfusion in past 14 days; hemoglobin >9g/dL without transfusion or erythropoietin in past 14 days
Kidney function
Serum creatinine ≤1.5×ULN and creatinine clearance ≥60 ml/min
Liver function
Total bilirubin ≤1.5×ULN; AST and ALT ≤2.5×ULN (≤5×ULN with liver metastases)
Cardiac function
Myocardial enzyme spectrum is within the normal range (if the researcher comprehensively judges that simple laboratory abnormalities without clinical significance are also allowed to be included)
With sufficient organ function, subjects must meet the following laboratory indicators: ... (see full criteria for details)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06421298 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic anti-tumor treatment, investigational drug disqualifies patients from enrollment.
Does this trial require ALK?
Yes, ALK wild-type is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR wild-type is a required biomarker for enrollment.
What disease stage is eligible?
Stage IIIB or IIIC or IV is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify