NCT06536868 Tislelizumab Combined With Chemotherapy and Thoracic Radiotherapy in ES-SCLC
| NCT ID | NCT06536868 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Second Hospital of Shanxi Medical University |
| Condition | Extensive-stage Small-cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2026-12-31 |
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 40 participants in total. It began in 2024-08-01 with a primary completion date of 2026-12-31.
⚠ 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
This study is a single arm, open, multicenter phase II study. The main purpose of this study was to evaluate preliminary efficacy and safety of Tislelizumab combined with thoracic radiotherapy as first line therapy for Extensive stage small cell lung cancer.
Eligibility Criteria
Inclusion Criteria: * Patients aged between 18 to 80 years old (inclusive of 18th and 80th birthdays), male or female, at the time of signing the informed consent form; * Confirmed small cell lung cancer of extensive stage by histology or cytology; * At least one measurable lesion by imaging studies (according to RECIST 1.1) with a long diameter of ≥10 mm as examined by spiral CT or MRI; * Within 3 days prior to treatment, an ECOG score of 0 to 1; * No prior antitumor treatment for extensive stage disease (if the patient has previously received chemotherapy and/or radiotherapy in the limited stage of SCLC, the treatment intent must have been curative, and there must be at least a 6-month treatment-free interval between the end of chemotherapy, radiotherapy, or chemoradiotherapy and the diagnosis of extensive stage SCLC); * Expected life span of ≥3 months; * Good function of vital organs; * The subject voluntarily joins this study, signs the informed consent form, has good compliance, and cooperates with follow-up. Exclusion Criteria: * Concurrent severe respiratory diseases: such as pulmonary fibrosis; * Presence of psychiatric disorders, hematologic diseases, autoimmune diseases, and severe primary diseases of the heart, brain, liver, or kidneys; * Uncontrolled active infections; * Known or suspected allergies to the study medication and its excipients; * Female patients who are pregnant or breastfeeding, or women of childbearing potential with a positive baseline pregnancy test; * Prior use of antitumor treatment targeting the PD-(L)1 pathway.
Contact & Investigator
Gang Jin, Dr.
PRINCIPAL INVESTIGATOR
Second Hospital of Shanxi Medical University
Frequently Asked Questions
Who can join the NCT06536868 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Extensive-stage Small-cell Lung Cancer. 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 NCT06536868 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 NCT06536868 currently recruiting?
Yes, NCT06536868 is actively recruiting participants. Contact the research team at jingang2018@sina.com for enrollment information.
Where is the NCT06536868 trial being conducted?
This trial is being conducted at Jincheng, China, Jinzhong, China, Taiyuan, China, Taiyuan, China and 2 additional locations.
Who is sponsoring the NCT06536868 clinical trial?
NCT06536868 is sponsored by Second Hospital of Shanxi Medical University. The principal investigator is Gang Jin, Dr. at Second Hospital of Shanxi Medical University. The trial plans to enroll 40 participants.
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