Phase II Trial: Low-Dose Radiation + SBRT + Sintilimab + Chemotherapy vs. Sintilimab + Chemotherapy in Locally Advanced or Metastatic Squamous Cell Lung Cancer

Last updated: August 10, 2024
Sponsor: Sichuan University
Overall Status: Active - Recruiting

Phase

2

Condition

Lung Cancer

Squamous Cell Carcinoma

Treatment

Sintilimab

chemotherapy

low-dose radiation therapy and stereotactic body radiation therapy

Clinical Study ID

NCT06121505
IHC-002
  • Ages 18-75
  • All Genders

Study Summary

This is a randomized, controlled, open-label, multicenter phase II clinical trial comparing the efficacy and safety of low-dose radiation therapy and stereotactic body radiation therapy combined with PD-1 inhibitor (sintilimab) and standard platinum-based doublet chemotherapy versus PD-1 inhibitor (sintilimab) combined with standard platinum-based doublet chemotherapy as first-line treatment in patients with locally advanced or metastatic squamous cell lung cancer.

There will be 57 subjects in the experimental group and 57 subjects in the control group, with a total of 114 subjects.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 18 years old and ≤ 75 years old;

  2. Histologically or cytologically confirmed squamous cell lung cancer, imagingconfirmed locally advanced or metastatic disease (unresectable or not eligible fordefinitive chemoradiotherapy, stage IIIB-IV);

  3. According to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), thereis at least one imaging measurable lesion;

  4. Enough to provide quality control qualified tumor tissue or cell wax blocks todetect PD-L1 expression;

  5. Have not received any systemic anti-tumor treatment for locally advanced ormetastatic disease in the past;

Exclusion

Exclusion Criteria:

  1. The pathology is small cell lung cancer (SCLC), including lung cancer mixed withSCLC and non-small cell lung cancer (NSCLC)；

  2. The pathology is lung adenocarcinoma, including lung cancer mixed with lungadenocarcinoma and lung squamous cell carcinoma;

  3. EGFR gene sensitive mutation or ALK fusion positive or ROS1 fusion positive;

  4. Previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2drugs or another drug that stimulates or synergistically inhibits T cell receptors;

  5. Pregnant or lactating women;

Study Design

Total Participants: 114
Treatment Group(s): 3
Primary Treatment: Sintilimab
Phase: 2
Study Start date:
March 01, 2024
Estimated Completion Date:
February 28, 2027

Study Description

This is a randomized, controlled, open-label, multicenter phase II clinical trial comparing the efficacy and safety of low-dose radiation therapy and stereotactic body radiation therapy combined with PD-1 inhibitor (sintilimab) and standard platinum-based doublet chemotherapy versus PD-1 inhibitor (sintilimab) combined with standard platinum-based doublet chemotherapy as first-line treatment in patients with locally advanced or metastatic squamous cell lung cancer. Patients with previously untreated, locally advanced or metastatic (unresectable or not eligible for definitive chemoradiotherapy, stage IIIB-IV) squamous cell lung cancer who have signed informed consent will be screened for eligibility. Qualified subjects who meet the inclusion criteria will be randomly assigned at a 1:1 ratio to the experimental group (radiation therapy plus sintilimab and chemotherapy) or the control group (sintilimab plus chemotherapy). Based on sample size estimation according to statistical hypotheses, there will be 57 subjects in the experimental group and 57 subjects in the control group, with a total of 114 subjects. Subjects in the experimental group will receive radiation therapy. Within 1 week after radiation therapy, they will receive treatment with sintilimab combined with standard platinum-based doublet chemotherapy. Chemotherapy combined with immunotherapy will consist of a total of 4 cycles. Patients will subsequently receive maintenance therapy with sintilimab. Subjects in the control group will receive treatment with sintilimab combined with standard platinum-based doublet chemotherapy, consisting of a total of 4 cycles. Patients will subsequently receive maintenance therapy with sintilimab. The primary efficacy endpoint of this study is objective response rate (ORR), as assessed by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1).

Connect with a study center

  • West China Hospital of Sichuan University

    Chengdu, Sichuan 610044
    China

    Active - Recruiting

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