NCT07085182 Tislelizumab Combined With sCRT in Stage IIIB/C-IV Non-Squamous Non-Small Cell Lung Cancer：A Prospective, Single-Arm, Phase II Study
| NCT ID | NCT07085182 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Zibo Municipal Hospital |
| Condition | NSCLC |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-01-13 |
| Primary Completion | 2027-12-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2024-01-13 with a primary completion date of 2027-12-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In clinical practice, some patients cannot tolerate concurrent chemoradiotherapy. The purpose of this study is to observe the efficacy and safety of Tislelizumab combined with platinum-based doublet chemotherapy followed by hypofractionated radiotherapy and Tislelizumab in patients with stage IIIB/C-IV non-squamous non-small cell lung cancer. This study aims to provide more treatment options for patients with locally advanced non-small cell lung cancer.
Eligibility Criteria
Inclusion Criteria: 1. Age 18-75 years old, gender is not limited; 2. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. 3. Patients with stage IIIB/C-IV non-squamous non-small cell lung cancer confirmed by cytology or histology; 4. Patients who have not received prior systemic therapy; Exclusion Criteria: 1. Patients with uncontrolled autoimmune diseases; 2. Patients who have had autoimmune reactions in the past 6 months and have not improved or are unstable despite appropriate treatment, such as untreated or unstable pneumonia, thyroiditis, myocarditis, etc.; 3. Patients known to carry driver gene mutations such as EGFR mutation, ALK translocation, BRAF, ROS1, RET, MET, etc.; 4. Patients who have received prior systemic therapy, or those who have received adjuvant or neoadjuvant therapy with a recurrence time of less than 3 months from the last treatment; 5. Patients with known allergies or contraindications to the study drug or its excipients; 6. Pregnant or lactating female patients, or female patients of childbearing potential with a positive baseline pregnancy test; 7. Female patients of childbearing potential or male patients with reproductive plans who are unwilling to use effective contraception during the entire trial period and for 6 months after the end of the trial; 8. Patients whose comorbidities or other conditions may affect compliance with the protocol or are deemed unsuitable for participation in this study by the investigator.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07085182 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying NSCLC. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07085182 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07085182 currently recruiting?
Yes, NCT07085182 is actively recruiting participants. Contact the research team at 18953316759@163.com for enrollment information.
Where is the NCT07085182 trial being conducted?
This trial is being conducted at Zibo, China.
Who is sponsoring the NCT07085182 clinical trial?
NCT07085182 is sponsored by Zibo Municipal Hospital. The trial plans to enroll 20 participants.