Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID06714708

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

Led by Anhui Provincial Cancer Hospital · Updated on 2025-02-10

86

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness and safety of combining low dose radiotherapy with sintilimab and platinum-based chemotherapy as a pre-surgery treatment for patients with stage II-III non-small cell lung cancer (NSCLC). This phase 2 clinical trial focuses on patients diagnosed with NSCLC who are eligible for surgery and aims to improve treatment response before surgery. Participants are randomly assigned to one of two groups. One group receives two cycles of sintilimab and platinum-based chemotherapy along with low dose radiotherapy (30 Gy in 15 fractions). The other group receives two cycles of sintilimab and platinum-based chemotherapy without radiotherapy. The treatments are given every three weeks, and the chemotherapy drugs include cisplatin or carboplatin combined with pemetrexed or albumin paclitaxel. During the study, participants will undergo assessments including tumor response evaluations and pathological examinations up to 8 weeks after surgery to measure complete pathological response and major pathological response. Researchers will also monitor event-free survival for up to three years and objective response rates for about one year. Safety and organ function tests will be regularly performed to track treatment effects and participant health throughout the trial.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent and able to comply with study visits and procedures
  • Age 18 years or older
  • Diagnosed with primary non-small cell lung cancer (adenocarcinoma or squamous cell carcinoma) by cytology or histology
  • Clinical staging IIB (tumor >4cm), IIIA, or IIIB (resectable N2 only) according to AJCC 8th edition
  • Non-squamous NSCLC patients must have no EGFR sensitive mutations or ALK rearrangements; squamous NSCLC patients with these mutations are excluded
  • Suitable for radical lung resection surgery
  • Lung function adequate for surgery (FEV1 ≥ 50% predicted, MVV ≥ 50% predicted) with no surgical contraindications
  • Able to provide tissue samples for PD-L1 testing
  • At least one measurable lesion per RECIST V1.1
  • ECOG performance status 0 or 1
  • No prior systemic anti-tumor therapy or local radiotherapy for NSCLC
  • Adequate organ and bone marrow function within 7 days before enrollment
  • Negative pregnancy test for women of childbearing potential before treatment
  • Use of effective contraception if at risk of conception during study and for 180 days after
Not Eligible

You will not qualify if you...

  • Presence of small cell carcinoma, large cell neuroendocrine tumor, or sarcomatoid tumor components
  • Tumor invasion into diaphragm, mediastinum, heart, large vessels, trachea, esophagus, vertebrae, or other critical structures
  • Tumor of the superior sulcus of the lung
  • Tumor nodules in the opposite lung lobe without biopsy confirmation if suspected
  • Confirmed or suspected brain metastases
  • Participation in other interventional clinical trials or use of investigational drugs/devices within 4 weeks
  • Previous use of immune checkpoint inhibitors or adoptive cell immunotherapy
  • Use of certain immunomodulatory or anti-tumor traditional medicines within 2 weeks
  • Major surgery within 4 weeks or unhealed wounds
  • Live attenuated vaccine use within 4 weeks
  • Long-term systemic corticosteroid or immunosuppressive therapy
  • History of non-infectious pneumonia requiring steroids or current interstitial lung disease
  • Active autoimmune diseases needing systemic treatment within 2 years
  • Primary immunodeficiency or myocarditis history
  • Severe peripheral neuropathy (grade ≥ 2)
  • Recent severe thrombosis or coagulation disorders
  • Uncontrolled hypertension or hyperglycemia
  • Unstable systemic diseases or active infections
  • History of organ transplantation
  • Active HIV, syphilis, hepatitis B or C infections
  • Other malignancies within 5 years except certain treated cancers
  • Known allergies to chemotherapy regimen components
  • Pregnant, lactating, or planning pregnancy
  • Mental illness or substance abuse affecting compliance
  • Any condition that may interfere with study participation or results

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 6 weeks (two 3-week cycles)

Participants receive two cycles of sintilimab and platinum-based chemotherapy. Those in the experimental group also undergo low dose radiotherapy (30Gy/15 fractions) simultaneously during this period as neoadjuvant therapy for non-small cell lung cancer.

2 treatment visits every 3 weeks

Surgery

Duration - Up to 8 weeks after treatment

Participants undergo radical lung resection surgery following neoadjuvant treatment.

1 surgery visit

Follow-up

Duration - Up to 3 years

Participants are followed for assessment of treatment response, survival, and safety outcomes including pathologic response, event free survival, and objective response rate.

Periodic follow-up visits over the course of the study

Trial Site Locations

Total: 1 location

1

Anhui Provincial Cancer Hospital

Hefei, Anhui, China, 230001

Actively Recruiting

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Research Team

S

Shuanghu Yuan, MD., PhD.

L

Li Li, MD., PhD.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Neoadjuvant low-dose radiotherapy plus durvalumab and chemotherapy for potentially resectable stage III NSCLC: A phase Ib dose-escalation study.

Juan Li, Shun Lu, Yuke Tian...

https://pubmed.ncbi.nlm.nih.gov/38679201