Clinical Study on the Efficacy and Safety of LM-302 Injection Combined With Tislelizumab and Tisl… (NCT07385703) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Clinical Study on the Efficacy and Safety of LM-302 Injection Combined With Tislelizumab and Tislelizumab Combined Chemotherapy for the Treatment of Gastric or Gastroesophageal Junction Adenocarcinoma.
China752 participantsStarted 2026-03
Plain-language summary
This study primarily evaluates the efficacy and safety of the LM-302 plus tislelizumab regimen versus tislelizumab plus chemotherapy in the treatment of previously untreated locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma patients with CLDN18.2 positivity.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Willing and able to comply with the study's visit schedule, treatment plan, laboratory tests, and other research procedures.
* Age ≥ 18 years.
* Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction.
* For locally advanced unresectable or metastatic adenocarcinoma of the stomach or gastroesophageal junction that has not previously received any systemic treatment:
* Patients who have previously received radical neoadjuvant chemotherapy or adjuvant chemotherapy (radiotherapy) based on a platinum-based combination chemotherapy regimen and have not developed distant metastasis or local recurrence within 6 months after completion of treatment can be included.
* The calculation of a 6-month interval is defined as recurrence within the same date range after 6 months. For example, if the end date of the last treatment is January 1, the 6-month period from that date refers to January 1 to July 1 (including July 1). Alternatively, if the end date of the last treatment is August 31, the 6-month period from that date refers to August 31 to February 28 (or February 29 in leap years).
* Archived specimens or fresh tumor tissue specimens from ≤3 years ago must be provided for CLDN18.2 and PD-L1 testing (PD-L1 results are not a condition for enrollment). When multiple samples are present, the most recent accessible and qualified sample must be provided. After confirmation by the central laboratory, tumor tissue with p…
What they're measuring
1
Progression-free survival (PFS)
Timeframe: 1.5 years
Trial details
NCT IDNCT07385703
SponsorShanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.