Trial · NCT07886047
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) in the Extensive-Stage SCLC Cohort | Through study completion, up to 24 months. | Objective response rate is defined as the proportion of participants with extensive-stage small cell lung cancer who achieve a best overall response of complete response (CR) or partial response (PR), as assessed by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. |
| Primary | Disease Control Rate (DCR) in the Extensive-Stage SCLC Cohort | Through study completion, up to 24 months. | Disease control rate is defined as the proportion of participants with extensive-stage small cell lung cancer who achieve a best overall response of complete response (CR), partial response (PR), or stable disease (SD), as assessed by investigators according to RECIST version 1.1. |
| Primary | Incidence and Severity of Treatment-Emergent Adverse Events in the Extensive-Stage SCLC Cohort | Through study completion, up to 24 months. | Safety will be evaluated by the number and percentage of participants experiencing treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs) and immune-related adverse events (irAEs). Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0. |
| Primary | R0 Resection Rate in the Resectable Early-Stage SCLC Cohort | Perioperative | The R0 resection rate is defined as the proportion of participants scheduled for surgery who successfully undergo complete surgical resection with microscopically negative margins (R0) following neoadjuvant treatment with propranolol hydrochloride, adebrelimab, and platinum-based chemotherapy. |
| Primary | Incidence and Severity of Treatment-Related Adverse Events and Perioperative Complications in the Resectable Early-Stage SCLC Cohort | Through study completion, up to 12 months. | The incidence and severity of treatment-related adverse events and perioperative complications will be assessed in participants with resectable early-stage small cell lung cancer (SCLC). Safety during neoadjuvant therapy will be evaluated based on adverse events (AEs), serious adverse events (SAEs), and immune-related adverse events (irAEs), with severity graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0. Perioperative complications will be assessed based on the occurrence and severity of intraoperative and postoperative complications, including perioperative mortality. |
| Secondary | Progression-Free Survival (PFS) in the Extensive-Stage SCLC Cohort | Through study completion, up to 24 months. | Progression-free survival is defined as the time from the first dose of study treatment to the first documented disease progression, as assessed by investigators according to RECIST version 1.1, or death from any cause, whichever occurs first. |
| Secondary | Overall Survival (OS) | Through study completion, up to 24 months. | Overall survival is defined as the time from the first dose of study treatment to death from any cause. Participants who are alive at the time of analysis will be censored at the date they were last known to be alive. |
| Secondary | Pathological Complete Response (pCR) Rate in the Resectable Early-Stage SCLC Cohort | Perioperative | Pathological complete response is defined as the absence of residual viable tumor cells in the resected primary tumor and regional lymph nodes (ypT0N0) following neoadjuvant treatment. The pCR rate is calculated as the proportion of participants achieving pCR among those who undergo surgical resection. |
| Secondary | Major Pathological Response (MPR) Rate in the Resectable Early-Stage SCLC Cohort | Perioperative | Major pathological response is defined as 10% or less residual viable tumor cells in the resected primary tumor following neoadjuvant treatment. The MPR rate is calculated as the proportion of participants achieving MPR among those who undergo surgical resection. |
| Secondary | Disease-Free Survival (DFS) in the Resectable Early-Stage SCLC Cohort | Through study completion, up to 12 months. | Disease-free survival is defined as the time from surgical resection to the first occurrence of disease recurrence, a second primary malignancy, or death from any cause, whichever occurs first. Participants without an event will be censored at the date of the last adequate disease assessment. |
| Secondary | Incidence of Dose-Limiting Toxicities (DLTs) | Up to 24 months | Number and percentage of participants experiencing protocol-defined DLTs at each propranolol dose level, assessed separately in both cohorts. |
| Secondary | Recommended Phase II Dose (RP2D) of Propranolol Hydrochloride | 1 year | RP2D determined based on the 3+3 dose-escalation rules, observed DLTs, and overall safety and tolerability. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT07886047/registered