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Clinical Trial NCT06056115 for Lung Adenocarcinoma is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Efficacy and Safety of Tislelizumab for Lung Adenocarcinoma With Asymptomatic Brain Metastatic 20 Biomarker-Driven

Recruiting
Clinical Trial NCT06056115 is an interventional study for Lung Adenocarcinoma that is recruiting. It started on May 1, 2023 with plans to enroll 20 participants. Led by Hebei Medical University Fourth Hospital, it is expected to complete by December 12, 2026. The latest data from ClinicalTrials.gov was last updated on September 28, 2023.
Brief Summary
Brain metastasis of lung cancer is one of the most important metastasis pathways in patients with life-threatening diseases. This study explore the efficacy and safety of Tislelizumab combining with platinum-containing drug chemotherapy in the first-line treatment of Lung Adenocarcinoma With Asymptomatic Brain Metastatic. Meanwhile, Related biomarkers were explored to provide theoretical basis for efficacy evaluation...Show More
Official Title

Efficacy and Safety of Tislelizumab Combined With Platinum-containing Drug Chemotherapy in First-line Treatment of Lung Adenocarcinoma With Asymptomatic Brain Metastatic

Conditions
Lung Adenocarcinoma
Other Study IDs
  • 20220511
NCT ID Number
NCT06056115
Start Date (Actual)
2023-05-01
Last Update Posted
2023-09-28
Completion Date (Estimated)
2026-12-12
Enrollment (Estimated)
20
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalTislelizumab Combined With Platinum-containing Drug Chemotherapy
1. Tislelizumab PD-1 inhibitor 2. Platinum-containing drug chemotherapy
Tislelizumab,Platinum
1. Induction therapy stage: Tislelizumab plus platinum-containing drug chemotherapy was administered every 3 weeks and was expected to complete 6 cycles of treatment. 2. Maintenance treatment phase: After completion of the induction therapy phase, patients whose antitumor response was confirmed as complete response, partial response, and disease stable according to RECIST v1.1 criteria were admitted to maintenan...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
1 years PFS
the time from the date of first dose of study treatment to the date of first documentation of disease progression using RECIST v1.1 or death, whichever occurs first
up to 1year
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
The objective response rate (ORR)
Assessed by the Investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Through study completion, an average of 12 months
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  1. Patients with metastatic (stage IV) lung adenocarcinoma who have not been systematically treated and are histologically or cytologically confirmed as unable to undergo radical surgery or radiotherapy based on AJCC Stage VIII;
  2. Patients with brain metastases confirmed by imaging;
  3. Patients with asymptomatic BMS after initial diagnosis, local BMS surgery or radiotherapy;
  4. ECOG PS: 0-1;
  5. Measurable target lesions outside the skull (as per RECIST 1.1);
  6. Life expectancy greater than 3 months;

  1. Patients had been treated with immune checkpoint inhibitors such as anti-PD-1, PD-L1, or CTLA-4 therapy;
  2. The patient had received systemic chemotherapy as advanced treatment;
  3. Patients with EGFR mutation or ALK gene translocation;
  4. The patient had received approved systemic anticancer therapy or systemic immunomodulators (including but not limited to interferon, interleukin 2, and tumor necrosis factor) within 4 weeks prior to initial administration;
  5. Clinically uncontrolled pleural fluid or ascites requiring puncture drainage within 2 weeks prior to initial administration;
Hebei Medical University Fourth Hospital logoHebei Medical University Fourth Hospital
Study Responsible Party
Jian SHI, Principal Investigator, Professor, Hebei Medical University Fourth Hospital
Study Central Contact
Contact: Jian Shi, Dr., +86-311-86095794, [email protected]
1 Study Locations in 1 Countries

Hebei

The Fourth Hospital of Hebei Medical University (Hebei Tumor Hospital), Shijiazhuang, Hebei, China
Jian Shi, Dr., Contact, +86-311-86095794, [email protected]
Recruiting