Primary Tumor Resection With Sintilimab and Chemotherapy in Advanced NSCLC
ConditionNon Small Cell Lung Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJianxing He
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
Impaired immune function: history of primary immunodeficiency; history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Cytoreductive surgery
Procedure/Surgery* Preoperative evaluation must confirm resectability. Thoracoscopic minimally invasive surgery will be performed, with the surgical approach selected according to disease conditions, such as lobectomy, segmentectomy, wedge resection, or sleeve resection; ② Systematic mediastinal lymph node dissection or lymph node sampling (based on preoperative imaging and intraoperative evaluation) must be performed; ③ Postoperative recovery must be adequate (postoperative complications ≤ Clavien-Dindo grade II).
Immunochemotherapy
Drug1. Treatment phase: ① Sintilimab Dose: 200 mg, administered intravenously over 30 minutes or less; ② Pemetrexed Dose: 500 mg/m², administered intravenously over 10 minutes or less; ③ Carboplatin Dose: administered according to the area under the curve (AUC) of 5 mg/mL/min, with infusion time controlled within 15-60 minutes. The above regimen will be administered every 3 weeks after surgery for a total of 4 cycles. 2. Maintenance phase: * Sintilimab Dose: 200 mg, administered intravenously over 30 minutes or less; ② Pemetrexed Dose: 500 mg/m², administered intravenously over 10 minutes or less; The above regimen will be administered every 3 weeks. Maintenance with sintilimab will continue for up to 31 cycles, or the total duration of systemic therapy from randomization will not exceed 2 years, or until disease progression or the occurrence of unacceptable toxicity
Treatment groups
118 Participants
are divided into 2 treatment groupsGroup A: SurgeryActive comparator 1 intervention
Group B: Intervention GroupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Progression-Free Survival (PFS)
PFS is defined as the time from randomization to the first documentation of disease progression (PD) or death from any cause, whichever occurs first. Disease progression will be assessed by the Independent Radiology Review Committee (IRRC) according to RECIST version 1.1 criteria.
Time frame
From randomization until the first documentation of disease progression or death from any cause, whichever occurs first (up to 5 years).Secondary outcomes
1
Overall Survival (OS)
OS is defined as the time from randomization to death from any cause.
Time frame
Randomization to death from any cause (up to 5 years).2
Objective Response Rate (ORR)
The proportion of patients achieving complete and partial remission after treatment, measured according to RECIST v1.1 criteria.
Time frame
Randomization until disease progression or death, which ever occurs first (up to 5 years).3
Disease Control Rate (DCR)
DCR is defined as the proportion of participants with complete response, partial response, and stable disease, as determined by RECIST v1.1 criteria.
Time frame
Randomization until disease progression or death, which ever occurs first (up to 5 years).4
Adverse Events
Safety will be assessed by recording treatment-related adverse events (AEs) and serious adverse events (SAEs), graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame
Randomization up to approximately 5 years.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Jianxing He
Lead sponsor
The First Affiliated Hospital of Guangzhou Medical University
Sponsor institution
Source ClinicalTrials.gov
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