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

Status: Recruiting
Location: See location...
Intervention Type: Radiation, Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• Patients who meet all of the following inclusion criteria are eligible for inclusion in this study:

‣ Sign a written Informed Consent Form (ICF) and be able to comply with the visit and related procedures specified in the protocol.

⁃ Age ≥ 18 years old.

⁃ Primary non-small cell lung cancer (including adenocarcinoma and squamous cell carcinoma) diagnosed by cytology or histology.

⁃ According to the International Association for the Study of Lung Cancer and the Joint Committee on Cancer Classification 8th edition (AJCC8) TNM staging classification of lung cancer, the clinical staging is IIB (primary tumor\>4cm), IIIA, or IIIB (resectable N2 only) stage. Resectable N2 refers to non bulk (defined as a short diameter less than 3cm), discrete, or single site N2 involvement. If clinically suspected as N2 or N3, pathological confirmation is required.

⁃ Non squamous NSCLC subjects need to undergo genetic testing to confirm the absence of EGFR sensitive mutations and ALK rearrangements. Squamous NSCLC subjects are not required to undergo genetic testing, but subjects with known EGFR sensitive mutations and ALK rearrangements should not be included in the study.

⁃ Considered suitable for radical resection surgery.

⁃ The lung function meets the criteria for planned lung resection (FEV1 ≥ 50% predicted value, MVV ≥ 50% predicted value), and there are no surgical contraindications.

⁃ Can provide sufficient tissue specimens that meet the requirements for PD-L1 testing during the screening period.

∙ According to RECIST V1.1, there is at least one measurable lesion. 10. The Eastern Cooperative Oncology Group Performance Status (ECOG PS) score is 0 or 1.

∙ 11\. Have not received any systemic anti-tumor therapy or local radiotherapy for NSCLC in the past.

∙ 12\. Possess sufficient organ and bone marrow function, with laboratory test values meeting the following requirements within 7 days prior to enrollment (no blood components, cell growth factors, albumin, or other intravenous or subcutaneous drugs for correcting hematological or liver and kidney dysfunction are allowed within 14 days prior to obtaining laboratory tests), as follows: Hematological function is sufficient, defined as absolute neutrophil count ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L, hemoglobin ≥ 100g/L;

• Adequate liver function, defined as total bilirubin levels ≤ 1.5 × upper limit of normal (ULN) and levels of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN, albumin (ALB) ≥ 35g/L;

• Adequate renal function, serum creatinine (Scr) ≤ 1.5 × ULN, creatinine clearance rate (CrCl) ≥ 60mL/min (calculated using the Cockcroft/Gault formula), and urine routine test results showing urinary protein (UPRO)\<2+or 24-hour urine protein dose\<1g; Within 7 days prior to treatment, the international normalized ratio (INR) is ≤ 1.5 × ULN, and the prothrombin time (PT) or activated partial thromboplastin time (APTT) is ≤ 1.5 × ULN.

• 13\. For female subjects of childbearing age, urine or serum pregnancy tests were negative within 7 days prior to receiving the first study drug administration. 14.If the urine pregnancy test result is positive, a blood pregnancy test is required.

‣ If there is a risk of conception, male and female patients should use highly effective contraception (i.e. methods with an annual failure rate of less than 1%) and continue for at least 180 days after stopping the trial treatment. Note: If abstinence is the subject's usual lifestyle and preferred contraceptive method, then abstinence is acceptable as a contraceptive method.

Locations
Other Locations
China
Anhui Provincial Cancer Hospital
RECRUITING
Hefei
Contact Information
Primary
Shuanghu Yuan, MD., PhD.
yuanshuanghu@sina.com
+86-0551-62894008
Backup
Li Li, MD., PhD.
lililyde@163.com
+86-0551-62894008
Time Frame
Start Date: 2024-11-20
Estimated Completion Date: 2027-06-01
Participants
Target number of participants: 86
Treatments
Experimental: Low Dose Radiotherapy combined with Sintilimab and Chemotherapy
Neoadjuvant treatment:two cycles of sintilimab and platinum based chemotherapy,simultaneously undergoing radiotherapy 30Gy/15F
Active_comparator: Sintilimab in combination with Chemotherapy
Neoadjuvant treatment:two cycles of sintilimab and platinum based chemotherapy
Sponsors
Leads: Anhui Provincial Cancer Hospital

This content was sourced from clinicaltrials.gov