RecruitingPhase 2NCT06714708

Low Dose Radiotherapy Combined With Sintilimab and Chemotherapy as Neoadjuvant Therapy for Stage II-III NSCLC

SPARK: Safety and Efficacy of Low Dose Radiotherapy Combined With Sintilimab and Platinum Based Chemotherapy as Neoadjuvant Therapy for Stage II-III Non-Small Cell Lung Cancer


Sponsor

Anhui Provincial Cancer Hospital

Enrollment

86 participants

Start Date

Nov 20, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

To evaluate efficacy and safety of low dose radiotherapy combined with sintilimab and platinum based chemotherapy as neoadjuvant therapy for stage II-III Non-Small Cell Lung Cancer


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding low-dose radiotherapy to a combination of immunotherapy (sintilimab) and chemotherapy before surgery improves outcomes in people with stage II–III non-small cell lung cancer (NSCLC). The goal is to shrink the tumor as much as possible before the operation. **You may be eligible if...** - You are 18 or older with newly diagnosed, surgically removable NSCLC (adenocarcinoma or squamous cell type) - Your cancer is stage IIB (tumor >4 cm), IIIA, or select IIIB - Your lung function is adequate for the planned surgery - You do not have EGFR or ALK gene mutations (required for non-squamous NSCLC) - You are in good health (ECOG 0–1) **You may NOT be eligible if...** - Your cancer has spread beyond the lungs (distant metastases) - You have active autoimmune disease or are on systemic steroids - You have had prior lung cancer treatment - Your lung function is too low for surgery - You have known EGFR/ALK mutations (non-squamous type) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONExperimental

Radiation: 30Gy/15F Drug: Sintilimab, 200mg IV D1 Q3W Drug: Cisplatin, 75mg/m2 D1 IV Q3W or Carboplatin AUC 5-6mg/ml/min D1 IV Q3W Drug: Pemetrexed, 500mg/m2 D1 IV Q3W or Albumin paclitaxel 260mg/m2,D1 or 130mg/m2,D1,8 IV Q3W

DRUGActive comparator

Drug: Sintilimab, 200mg IV D1 Q3W Drug: Cisplatin, 75mg/m2 D1 IV Q3W or Carboplatin AUC 5-6mg/ml/min D1 IV Q3W Drug: Pemetrexed, 500mg/m2 D1 IV Q3W or Albumin paclitaxel 260mg/m2,D1 or 130mg/m2,D1,8 IV Q3W


Locations(1)

Anhui Provincial Cancer Hospital

Hefei, Anhui, China

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NCT06714708


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