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SDTM001 Injection: Recruiting Postoperative Patients with Non Small Cell Lung Cancer in Multiple Centers Nationwide

Release time:2025.05.27

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Dear non-small cell lung cancer patients:

Cytocraft is conducting a mid-term clinical trial (protocol number: SDTM001-2024) of SDTM001 injection as adjuvant therapy for non-small-cell lung cancer (NSCLC) patients with negative driver gene mutations and PD-L1 expression after surgical resection. This study was conducted by West China Hospital of Sichuan University as the leading unit, in collaboration with the First Affiliated Hospital of Zhengzhou University, Shandong Provincial Hospital, Tongji Medical College Affiliated Union Hospital of Huazhong University of Science and Technology, Yunnan Cancer Hospital, and the Second Affiliated Hospital of Army Medical University (Xinqiao Hospital) to evaluate the efficacy of the drug in postoperative patients with negative driver gene mutations and PD-L1 expression. This study has obtained clinical trial approval from the National Medical Products Administration (Notice No. 2024LP02154) and passed ethical review. It is now open for public recruitment of subjects.

 

一、Recruitment criteria

  1. Age range: 18-70 years old;
  2. Patients diagnosed with primary NSCLC and who have undergone radical surgical resection (R0) treatment are classified as stage IIA-IIIB according to the AJCC 9th edition TNM staging;
  3. Radical surgical resection (R0) treatment has been performed for no more than 1 year after surgery, and there has been no disease recurrence (including local recurrence);
  4. Previous mutations in driver genes such as EGFR and ALK were negative, and PD-L1 expression in tumor tissue was negative after testing;
  5. Platinum based chemotherapy (one to four cycles) has been completed before screening.

 

二、If you participate in this study, what cooperation is required

1. Before selection, doctors screen patients based on their condition according to the inclusion and exclusion criteria. Patients need to understand the basic content of this study and sign an informed consent form;

2. After enrollment, relevant examinations related to the clinical study are required, and peripheral blood collection and treatment arrangements are made according to the experimental protocol design. Relevant examinations are required during and after the treatment process;

3. After the treatment is completed, it is necessary to cooperate with the doctor for follow-up work, with a follow-up period of 2 years;

4. If you participate in this study, the relevant examinations and investigational drugs during the study period will be borne by the sponsor.

 

三、Recruitment period

From now until the recruitment is full.

 

四、Scope of this recruitment

Internally within the hospital, including the hospital, sponsor and related websites, as well as other relevant media.

Whether to participate or not depends entirely on your willingness. If you are interested in participating, please contact the research doctor who will provide you with a detailed introduction to this study and make a preliminary assessment of whether you meet the inclusion requirements. Even if you do not wish to participate in this study, you will not be adversely affected and will be kept confidential.

 

五、Contact information

Teacher Jia: 18783353441

 

 

Cytocraft

May 27, 2025

 

 

 

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