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New treatment option for Extensive-stage Small-cell Lung Cancer
Official title Tislelizumab Combined With Chemotherapy and Thoracic Radiotherapy in ES-SCLC
ClinicalTrials.gov ID: NCT06536868
What this study is testing
What is Tislelizumab?
Tislelizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for extensive-stage small-cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
You likely can't join if
- 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.
See the full eligibility 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Jincheng, Shanxi, China
- Jinzhong, Shanxi, China
- Taiyuan, Shanxi, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jincheng, Shanxi, China; Jinzhong, Shanxi, China; Taiyuan, Shanxi, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.