Actively Recruiting
Efficacy and Safety of Tislelizumab Combined With Platinum-containing Drug Chemotherapy in First-line Treatment of Lung Adenocarcinoma With Asymptomatic Brain Metastatic
Led by Hebei Medical University Fourth Hospital · Updated on 2023-09-28
20
Participants Needed
1
Research Sites
87 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to study the safety and effectiveness of combining Tislelizumab, a PD-1 inhibitor, with platinum-containing chemotherapy drugs as the first-line treatment for patients with lung adenocarcinoma who have asymptomatic brain metastases. The study also explores related biomarkers to better understand treatment response and resistance mechanisms in this patient population. Lung cancer spreading to the brain is a serious condition requiring new treatment approaches. Participants will receive induction therapy where Tislelizumab combined with platinum-based chemotherapy is given every three weeks, expected for six cycles. Patients who show complete response, partial response, or stable disease after this phase may enter a maintenance treatment period to continue monitoring their condition. The study involves only one treatment group receiving this combination therapy. Throughout the study, participants will be assessed for progression-free survival up to one year as the primary outcome. Additional measures include the objective response rate during approximately 12 months. Patients will undergo regular evaluations including imaging to measure tumor response and safety monitoring. The study lasts until the end date in December 2026, with careful tracking of participants' health and treatment effects.
CONDITIONS
Brief Title
Efficacy and Safety of Tislelizumab for Lung Adenocarcinoma With Asymptomatic Brain Metastatic
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with metastatic (stage IV) lung adenocarcinoma not previously treated systemically
- Histologically or cytologically confirmed patients unable to undergo radical surgery or radiotherapy
- Patients with brain metastases confirmed by imaging
- Patients with asymptomatic brain metastases after diagnosis or local surgery/radiotherapy
- ECOG performance status of 0 or 1
- Measurable target lesions outside the skull as per RECIST 1.1
- Life expectancy greater than 3 months
You will not qualify if you...
- Prior treatment with immune checkpoint inhibitors such as anti-PD-1, PD-L1, or CTLA-4 therapies
- Previous systemic chemotherapy for advanced treatment
- Presence of EGFR mutation or ALK gene translocation
- Use of systemic anticancer therapy or immunomodulators within 4 weeks before study drug administration
- Clinically uncontrolled pleural fluid or ascites requiring drainage within 2 weeks before study drug administration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Induction therapy duration plus maintenance treatment as applicable
Participants receive Tislelizumab combined with platinum-containing drug chemotherapy every 3 weeks during the induction therapy stage, expected to complete 6 cycles. Those with confirmed antitumor response then continue with maintenance therapy.
Every 3 weeks during induction therapy
Trial Site Locations
Total: 1 location
1
The Fourth Hospital of Hebei Medical University (Hebei Tumor Hospital)
Shijiazhuang, Hebei, China
Actively Recruiting
Research Team
J
Jian Shi, Dr.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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