Primary Tumor Resection With Sintilimab and Chemotherapy in Advanced NSCLC (NCT07177105) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Primary Tumor Resection With Sintilimab and Chemotherapy in Advanced NSCLC
118 participantsStarted 2025-09-10
Plain-language summary
This study aims to evaluate whether resecting the primary tumor can improve the outcomes of treatment with sintilimab and chemotherapy in advanced EGFR/ALK-negative non-small cell lung cancer (NSCLC). Patients will be randomly assigned to one of two groups: one group will undergo primary tumor resection followed by sintilimab, pemetrexed, and carboplatin, while the other group will only receive sintilimab, pemetrexed, and carboplatin. The study will assess progression-free survival, overall survival, treatment response, safety, and the impact of treatment on quality of life. Through this study, we hope to determine whether primary tumor resection can provide additional benefits of anti-PD-1 therapy and chemotherapy for advanced NSCLC.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Age 18-75 years, no sex limitation;
✓. Histologically or cytologically confirmed stage III-IV non-squamous NSCLC, deemed unresectable (evaluated by MDT);
✓. Negative for EGFR mutation and ALK rearrangement (tested by ARMS-PCR, NGS, or equivalent methods);
✓. No histological evidence of small cell lung cancer (SCLC) or transformation to SCLC;
✓. No prior exposure to anti-tumor therapy;
✓. ECOG performance status of 0-1;
✓. Expected survival ≥ 6 months;
✓. Primary tumor diameter ≥ 1 cm, with at least one measurable lesion remaining after resection (per RECIST v1.1 criteria);
Exclusion criteria
✕. Impaired immune function: history of primary immunodeficiency; history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
What they're measuring
1
Progression-Free Survival (PFS)
Timeframe: From randomization until the first documentation of disease progression or death from any cause, whichever occurs first (up to 5 years).
. Active brain metastases. Patients with adequately treated brain metastases may be eligible if they have remained neurologically stable for at least 2 weeks prior to study entry and are not receiving systemic corticosteroids or are on a stable/reducing dose equivalent to ≤10 mg prednisone daily.
✕. Pregnancy.
✕. Presence of any severe, uncontrolled, or unstable comorbidity that, in the opinion of the investigator, may interfere with the patient's participation in the study or affect the interpretation of study results, including uncontrolled seizures, psychiatric disorders, active or uncontrolled infections, or other conditions (including laboratory abnormalities).