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

About this trial

Last updated 6 months ago

Study ID

IHC-002

Status

Recruiting

Type

Interventional

Phase

Phase 2

Placebo

Accepting

18 to 75 Years

All Sexes

Trial Timing

Started 2 years ago

What is this trial about?

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.

What are the participation requirements?

Inclusion Criteria

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

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

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

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

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

Exclusion Criteria

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

2. The pathology is lung adenocarcinoma, including lung cancer mixed with lung adenocarcinoma 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-L2 drugs or another drug that stimulates or synergistically inhibits T cell receptors;

5. Pregnant or lactating women;