Anhui Cancer Hospital
Hefei, Anhui, 230031, China
Location status: Recruiting
NCT Number: NCT06838208
To explore the efficacy and safety of Tislelizumab combined with chemotherapy and relayed radiotherapy in the first-line treatment of extensive small cell lung cancer
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Hefei, Anhui, 230031, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Induction therapy stage LDRT: lung lesions, 15Gy/5f; Maintenance therapy phase SBRT: The main residual lesions evaluated by the investigators, 30Gy/5f;
Other names: radiotherapy
Time frame: Baseline until PD or death, whichever occurs first or up to approximately 23 months
To evaluate the efficacy of Tislelizumab + cisplatin or carboplatin + etoposide and radiotherapy in the intent to treat (ITT) Analysis Set as measured by investigator assessed progression free survival (PFS) according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Time frame: Baseline until partial response (PR) or complete response (CR), whichever occurs or up to approximately 23 months
To evaluate the efficacy of Tislelizumab + cisplatin or carboplatin + etoposide +radiotherapy in the ITT Analysis Set as measured by investigator assessed overall response rate (ORR), according to RECIST v1.1
Time frame: Baseline until partial response (PR) or complete response (CR), whichever occurs first, or up to approximately 23 months
To evaluate the efficacy of Tislelizumab + cisplatin or carboplatin + etoposide+ radiotherapy in the ITT Analysis Set as measured by investigator assessed duration of response (DOR) according to RECIST v1.1
Time frame: up to approximately 23 months
To evaluate the efficacy of Tislelizumab + cisplatin or carboplatin + etoposide + radiotherapy in the ITT Analysis Set as measured by investigator assessed disease control rate (DCR) according to RECIST v1.1
Time frame: up to approximately 23 months
The PFS rate will be defined as the proportion of participants free from PFS events at 6 month and 1st year after the first dose.
Time frame: up to approximately 23 months
The OS rate will be defined as the proportion of participants free from OS events at 1st year after the first dose.
Time frame: up to approximately 23 months
Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to National Cancer Institute Common Terminology Criteria for Adverse Events
Contact information is provided by the study sponsor or research team.
Anhui Provincial Cancer Hospital
Other
Efficacy and Safety of Tislelizumab Combined With Chemotherapy and Relayed Radiotherapy in the First-line Treatment of Extensive Small Cell Lung Cancer: a Prospective, Multicenter, Phase II Clinical Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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