Small Cell Lung Cancer (SCLC)Phase 1BRIO-SCLCNCT07886047
Propranolol Hydrochloride Combined With Adebrelimab and Platinum-Based Chemotherapy in Small Cell Lung Cancer
A Phase 1 study testing Propranolol Hydrochloride, Adebrelimab and Chemotherapy in people with Small Cell Lung Cancer (SCLC), run by Second Xiangya Hospital of Central South University at 4 sites in China.
Trial summary
This is a prospective multicenter, open-label, Phase I clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of propranolol hydrochloride in combination with adebrelimab and platinum-based chemotherapy in patients with small cell lung cancer (SCLC).The study includes two cohorts… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Small Cell Lung Cancer (SCLC)
- What is being tested?
- Propranolol Hydrochloride, Adebrelimab and Chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 4 sitesChina
- Study dates
- 29 May 2026to 31 Dec 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent must be obtained prior to any study-related procedures
- Age ≥18 years and ≤75 years.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1
- Life expectancy ≥12 weeks.
- Histologically or cytologically confirmed extensive-stage (ES) SCLC or T1-2N0M0 stage SCLC patients(9th UICC/AJCC TNM staging). Extensive-stage patients not amenable to local therapy include both recurrent and treatment-naïve patients not suitable for local treatment (surgery and definitive concurrent chemoradiotherapy), who have not previously received systemic therapy for advanced/metastatic disease.
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. Lesions located within prior radiation fields may be considered measurable if progression has been documented (within 28 days prior to first treatment).
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- Asymptomatic or symptomatic brain metastases that have been locally treated and are stable are allowed in ES-SCLC cohort, provided the subject meets the following conditions: Measurable disease outside the central nervous system (CNS) No CNS symptoms, or symptoms stable for at least 2 weeks No corticosteroid treatment required, or corticosteroids discontinued at least 7 days prior to first dose, or stable corticosteroid dose at ≤10 mg/day prednisone (or equivalent) for at least 7 days prior to first dose
- Laboratory Parameters (within 14 days prior to first treatment) Hematologic: Absolute neutrophil count (ANC) ≥1.5×10⁹/L; platelet count ≥100×10⁹/L; hemoglobin ≥9.0 g/dL (without transfusion or erythropoietin administration within 7 days). Hepatic: Total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (in absence of hepatic metastases). For patients with hepatic metastases: ALT or AST ≤5×ULN. Renal: Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance ≥60 mL/min (by Cockcroft-Gault formula), and urinalysis showing urine protein (UPRO) <2+ or 24-hour urine protein <1 g. Coagulation: Within 7 days prior to study treatment: International normalized ratio (INR) ≤1.5×ULN or prothrombin time (PT) ≤1.5×ULN; if subject is receiving anticoagulant therapy, PT within the intended therapeutic range of the anticoagulant is acceptable.
- New York Heart Association (NYHA) Class <3; left ventricular ejection fraction (LVEF) ≥50%; baseline electrocardiogram (ECG) showing no PR interval prolongation or atrioventricular block.
- For women of childbearing potential (WOCBP), a negative urine or serum pregnancy test must be obtained within 3 days prior to first study drug administration (Cycle 1 Day 1). If urine pregnancy test results cannot be confirmed as negative, a serum pregnancy test is required. Non-childbearing potential is defined as postmenopausal for at least 1 year, or surgically sterile (bilateral oophorectomy, hysterectomy, or tubal ligation). All subjects (male and female) with reproductive potential must use highly effective contraception (failure rate <1% per year) throughout the treatment period and for 120 days (or 180 days) after the last dose of study drug.
Who cannot join
- Concurrent participation in another interventional clinical study or receiving other investigational drugs, unless participating in an observational clinical study.
- Prior exposure to any anti-PD-1 or anti-PD-L1, PD-L2, CD137, CTLA-4 antibody therapy, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
- Systemic treatment with Chinese patent medicines with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, and interleukins; except for local administration to control pleural effusion or ascites) within 2 weeks prior to first dose.
- Current use of oral or intravenous beta-blockers (e.g., atenolol, bisoprolol, carvedilol, labetalol, metoprolol, nadolol, sotalol, etc.) that cannot be safely switched to non-beta-blocker alternatives. Current subjects should have a washout period of at least 14 days with adequate transition period.
- Contraindications to Beta-Blocker Use Hypersensitivity to any component of this product Bronchial asthma or risk of bronchospasm Ketoacidosis and metabolic acidosis Severe or symptomatic bradycardia, atrioventricular block (Grade II or III), sinoatrial block, sick sinus syndrome Cardiogenic shock Right heart dysfunction caused by pulmonary hypertension Congestive heart failure (NYHA Class III or IV) Hypotension (systolic blood pressure <100 mmHg) Prolonged fasting state Severe peripheral circulatory failure (e.g., gangrene) Symptomatic peripheral arterial disease or Raynaud's syndrome, untreated pheochromocytoma Unstable angina or Prinzmetal's angina Concurrent use of rizatriptan benzoate Severe chronic obstructive pulmonary disease (COPD) Uncontrolled Type I or Type II diabetes mellitus (glycated hemoglobin [HbA1C] >8.5 or fasting glucose >160 mg/dL at screening)
- Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Class B or more severe cirrhosis.
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- Malignant bowel obstruction (within 3 months prior to informed consent signing) or history of the following conditions: inflammatory bowel disease or extensive intestinal resection (partial colectomy or extensive small bowel resection with concurrent chronic diarrhea), Crohn's disease, or ulcerative colitis.
- Completion of palliative radiotherapy within 7 days prior to first study drug administration.
- Clinically active diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction.
- History of psychoactive drug abuse or drug addiction.
- Known hypersensitivity to active ingredients or excipients of the study drug.
- Known history of primary immunodeficiency, or ongoing systemic corticosteroid therapy or any other form of immunosuppressive therapy.
- Use of immunosuppressive drugs within 4 weeks prior to first study treatment, excluding intranasal, inhaled, or other routes of topical corticosteroids, or physiological doses of systemic corticosteroids (i.e., not exceeding 10 mg/day prednisone or equivalent dose of other corticosteroids), or corticosteroids used for prevention of contrast agent allergy.
- Failure to recover adequately (i.e., to Grade ≤1 or baseline, excluding fatigue or alopecia) from any intervention-induced toxicities and/or complications prior to starting treatment.
- Receipt of live attenuated vaccines within 4 weeks prior to first study treatment or planned vaccination during the study (inactivated influenza vaccine for seasonal influenza is allowed within 4 weeks prior to first dose; however, live attenuated influenza vaccine is not permitted).
- Major surgery (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to first study treatment, or expectation of requiring major surgery during study treatment; laparoscopic exploratory surgery within 2 weeks prior to first study treatment.
- Known symptomatic central nervous system metastases and/or carcinomatous meningitis. Exception may be made for subjects with previously treated brain metastases if the subject's condition is stable (no evidence of radiographic progression for at least 4 weeks prior to first dose of trial treatment, confirmed by repeat imaging showing no new brain metastases or enlargement of existing brain metastases), and no corticosteroid treatment is required for at least 14 days prior to first dose of trial treatment. This exception does not include carcinomatous meningitis, which should be excluded regardless of clinical stability.
- Clinically uncontrolled pleural effusion or ascites (subjects who do not require drainage of effusion or in whom effusion does not significantly increase 3 days after stopping drainage may be enrolled).
- Bone metastases with risk of paraplegia.
- Known or suspected autoimmune disease or history of such disease within the past 2 years (subjects with vitiligo, psoriasis, alopecia, or Graves' disease not requiring systemic treatment within the past 2 years, hypothyroidism requiring only thyroid hormone replacement therapy, and Type 1 diabetes mellitus requiring only insulin replacement therapy may be enrolled).
- Known active tuberculosis.
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Known history of human immunodeficiency virus (HIV) infection (i.e., HIV antibody positive).
- Known acute or chronic active hepatitis B virus (HBsAg positive with HBV DNA viral load ≥200 IU/mL or ≥10³ copies/mL) or acute or chronic active hepatitis C virus (HCV antibody positive with HCV RNA positive).
- Active syphilis infection requiring treatment.
- Interstitial lung disease requiring corticosteroid therapy.
- Active or poorly controlled severe infection.
- Severe cardiovascular disease (e.g., myocardial infarction, arterial thromboembolism, cerebrovascular thromboembolism); angina requiring treatment; symptomatic peripheral vascular disease; NYHA Class 3 or 4 congestive heart failure; or uncontrolled Grade ≥3 hypertension (diastolic blood pressure ≥100 mmHg or systolic blood pressure ≥160 mmHg) despite antihypertensive treatment.
- History of other primary malignancies within 5 years, except for: Malignancies in complete remission for at least 2 years prior to enrollment with no other treatment required during the study Adequately treated non-melanoma skin cancer or lentigo maligna with no evidence of disease recurrence Adequately treated carcinoma in situ with no evidence of disease recurrence
- Pregnant or lactating female patients.
- Other acute or chronic medical conditions, psychiatric conditions, or laboratory abnormalities that may: increase the risk associated with study participation or study drug administration, or interfere with the interpretation of study results, and which, in the judgment of the investigator, render the patient ineligible for participation in this study.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
The Second Xiangya Hospital of Central south University
Changsha, Hunan, 410011
Fang Wu, MD, PhD, 8613575858332, wufang4461@csu.edu.cn
- Not yet recruiting
Hunan Cancer Hospital
Changsha, Hunan
Xingxiang Pu, MD, PhD, +86-15874180022, pxx_1354@163.com
- Not yet recruiting
The Third Xiangya Hospital of Central South University
Changsha, Hunan
Yan Zhou, MD, PhD, 86-13755013053, zhouyanxy3@csu.edu.cn
- Not yet recruiting
Xiangya Hospital, Central South University
Changsha, Hunan
Jian An, MD, PhD, +86-13617319398, 175162349@qq.com
About this study
Official title: Study of Propranolol Hydrochloride in Combination With Adebrelimab and Platinum-Based Chemotherapy in Patients With Small Cell Lung Cancer (BRIO-SCLC)
This is a prospective multicenter, open-label, Phase I clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of propranolol hydrochloride in combination with adebrelimab and platinum-based chemotherapy in patients with small cell lung cancer (SCLC).The study includes two cohorts: patients with previously untreated extensive-stage SCLC and patients with resectable early-stage (T1-2N0M0) SCLC. Propranolol hydrochloride is a beta- adrenergic blocking agent which is associated with augment of immune cell responses. Propranolol hydrochloride may improve the responses of immune checkpoint inhibitors in treating patients with SCLC.
- Conditions
- Small Cell Lung Cancer (SCLC)
- Being tested
- Propranolol Hydrochloride, Adebrelimab, Chemotherapy
- Keywords
- Small Cell Lung Cancer, Propranolol, Beta-Adrenergic Blockade, Adebrelimab, Immune Checkpoint Inhibitors
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propranolol HydrochlorideDrug
Also called Inderal
Propranolol hydrochloride is administered orally at three planned dose levels: 10 mg twice daily (BID), 10 mg three times daily (TID), and 20 mg twice daily (BID). Dose escalation follows a conventional 3+3 design in both study cohorts to evaluate safety, dose-limiting toxicities, and the recommended Phase II dose (RP2D).
AdebrelimabDrug
Adebrelimab is administered intravenously at a dose of 1200 mg on Day 1 of each 21-day cycle in combination with propranolol hydrochloride and platinum-etoposide chemotherapy. In the extensive-stage SCLC cohort, adebrelimab is continued as maintenance therapy for up to 2 years. In the resectable early-stage SCLC cohort, adebrelimab is administered as neoadjuvant treatment followed by postoperative therapy for up to 1 year, according to the study protocol.
ChemotherapyDrug
Platinum-based doublet chemotherapy consists of etoposide plus either carboplatin or cisplatin.
Etoposide: 100 mg/m² intravenously on Days 1-3 of each 21-day cycle.
Carboplatin: AUC 5 intravenously on Day 1 of each 21-day cycle; or
Cisplatin: 75 mg/m² intravenously on Day 1 of each 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Extensive-Stage SCLC Cohort | Experimental | Patients with previously untreated extensive-stage small cell lung cancer (ES-SCLC) will receive oral propranolol hydrochloride at escalating dose levels (10 mg BID, 10 mg TID, and 20 mg BID) using a 3+3 design, in combination with adebrelimab and platinum-based chemotherapy every 3 weeks for 4-6 cycles. This will be followed by maintenance treatment with propranolol hydrochloride and adebrelimab for up to 2 years or until disease progression, unacceptable toxicity, or other protocol-defined discontinuation criteria are met. Safety, tolerability, dose-limiting toxicities, and the recommended Phase II dose will be evaluated. Receives: Drug: Propranolol Hydrochloride; Drug: Adebrelimab; Drug: Chemotherapy |
| Resectable Early-Stage (T1-2N0M0) SCLC Cohort | Experimental | Patients with resectable early-stage (T1-2N0M0) SCLC will receive neoadjuvant propranolol hydrochloride at escalating dose levels (10 mg BID, 10 mg TID, and 20 mg BID) using a 3+3 dose-escalation design, in combination with adebrelimab and platinum-based chemotherapy every 3 weeks for 3-4 cycles, followed by surgical resection. Postoperatively, patients will continue treatment with propranolol hydrochloride and adebrelimab for up to 1 year. Safety, tolerability, dose-limiting toxicities, surgical feasibility, and pathological response will be evaluated. Receives: Drug: Propranolol Hydrochloride; Drug: Adebrelimab; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) in the Extensive-Stage SCLC Cohort
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.
Measured: Through study completion, up to 24 months.
Disease Control Rate (DCR) in the Extensive-Stage SCLC Cohort
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.
Measured: Through study completion, up to 24 months.
Incidence and Severity of Treatment-Emergent Adverse Events in the Extensive-Stage SCLC Cohort
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.
Measured: Through study completion, up to 24 months.
R0 Resection Rate in the Resectable Early-Stage SCLC Cohort
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.
Measured: Perioperative
Incidence and Severity of Treatment-Related Adverse Events and Perioperative Complications in the Resectable Early-Stage SCLC Cohort
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.
Measured: Through study completion, up to 12 months.
Secondary outcomes (7)
Progression-Free Survival (PFS) in the Extensive-Stage SCLC Cohort
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.
Measured: Through study completion, up to 24 months.
Overall Survival (OS)
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.
Measured: Through study completion, up to 24 months.
Pathological Complete Response (pCR) Rate in the Resectable Early-Stage SCLC Cohort
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.
Measured: Perioperative
Major Pathological Response (MPR) Rate in the Resectable Early-Stage SCLC Cohort
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.
Measured: Perioperative
Disease-Free Survival (DFS) in the Resectable Early-Stage SCLC Cohort
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.
Measured: Through study completion, up to 12 months.
Incidence of Dose-Limiting Toxicities (DLTs)
Number and percentage of participants experiencing protocol-defined DLTs at each propranolol dose level, assessed separately in both cohorts.
Measured: Up to 24 months
Recommended Phase II Dose (RP2D) of Propranolol Hydrochloride
RP2D determined based on the 3+3 dose-escalation rules, observed DLTs, and overall safety and tolerability.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start29 May 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung Cancer (SCLC)Studies of the same condition, open and under way.
- More trials run by Second Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study includes two parallel, non-randomized cohorts: patients with extensive-stage small cell lung cancer and patients with resectable early-stage (T1-2N0M0) small cell lung cancer. Both cohorts are conducted concurrently and undergo protocol-defined dose escalation. The cohorts are evaluated separately and are not intended for direct comparative analysis.
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Shengdi Pharmaceutical Co., Ltd
- Responsible party
- Principal investigator, Fang Wu, Second Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07886047
- Sponsor's protocol ID
- LYG20260075
- Acronym
- BRIO-SCLC
- Status last verified
- Oct 2026
- First submitted
- 11 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Propranolol Hydrochloride in Combination With Adebrelimab and Platinum-Based Chemotherapy in Patients With Small Cell Lung Cancer (BRIO-SCLC)
- ClinicalTrials.gov ID
- NCT07886047
- Acronym / sponsor ID
- BRIO-SCLC / LYG20260075
- Conditions
- Small Cell Lung Cancer (SCLC)
- Keywords
- Small Cell Lung Cancer, Propranolol, Beta-Adrenergic Blockade, Adebrelimab, Immune Checkpoint Inhibitors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Second Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Collaborators
- Shanghai Shengdi Pharmaceutical Co., Ltd
- Study start
- 29 May 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 21 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective multicenter, open-label, Phase I clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of propranolol hydrochloride in combination with adebrelimab and platinum-based chemotherapy in patients with small cell lung cancer (SCLC).The study includes two cohorts: patients with previously untreated extensive-stage SCLC and patients with resectable early-stage (T1-2N0M0) SCLC. Propranolol hydrochloride is a beta- adrenergic blocking agent which is associated with augment of immune cell responses. Propranolol hydrochloride may improve the responses of immune checkpoint inhibitors in treating patients with SCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study includes two parallel, non-randomized cohorts: patients with extensive-stage small cell lung cancer and patients with resectable early-stage (T1-2N0M0) small cell lung cancer. Both cohorts are conducted concurrently and undergo protocol-defined dose escalation. The cohorts are evaluated separately and are not intended for direct comparative analysis.
| Arm | Type | Receives |
|---|---|---|
| Extensive-Stage SCLC Cohort | Experimental | Drug: Propranolol Hydrochloride, Drug: Adebrelimab, Drug: ChemotherapyPatients with previously untreated extensive-stage small cell lung cancer (ES-SCLC) will receive oral propranolol hydrochloride at escalating dose levels (10 mg BID, 10 mg TID, and 20 mg BID) using a 3+3 design, in combination with adebrelimab and platinum-based chemotherapy every 3 weeks for 4-6 cycles. This will be followed by maintenance treatment with propranolol hydrochloride and adebrelimab for up to 2 years or until disease progression, unacceptable toxicity, or other protocol-defined discontinuation criteria are met. Safety, tolerability, dose-limiting toxicities, and the recommended Phase II dose will be evaluated. |
| Resectable Early-Stage (T1-2N0M0) SCLC Cohort | Experimental | Drug: Propranolol Hydrochloride, Drug: Adebrelimab, Drug: ChemotherapyPatients with resectable early-stage (T1-2N0M0) SCLC will receive neoadjuvant propranolol hydrochloride at escalating dose levels (10 mg BID, 10 mg TID, and 20 mg BID) using a 3+3 dose-escalation design, in combination with adebrelimab and platinum-based chemotherapy every 3 weeks for 3-4 cycles, followed by surgical resection. Postoperatively, patients will continue treatment with propranolol hydrochloride and adebrelimab for up to 1 year. Safety, tolerability, dose-limiting toxicities, surgical feasibility, and pathological response will be evaluated. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Written informed consent must be obtained prior to any study-related procedures
- Age ≥18 years and ≤75 years.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1
- Life expectancy ≥12 weeks.
- Histologically or cytologically confirmed extensive-stage (ES) SCLC or T1-2N0M0 stage SCLC patients(9th UICC/AJCC TNM staging). Extensive-stage patients not amenable to local therapy include both recurrent and treatment-naïve patients not suitable for local treatment (surgery and definitive concurrent chemoradiotherapy), who have not previously received systemic therapy for advanced/metastatic disease.
Key exclusion criteria (31 listed)
- Concurrent participation in another interventional clinical study or receiving other investigational drugs, unless participating in an observational clinical study.
- Prior exposure to any anti-PD-1 or anti-PD-L1, PD-L2, CD137, CTLA-4 antibody therapy, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
- Systemic treatment with Chinese patent medicines with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, and interleukins; except for local administration to control pleural effusion or ascites) within 2 weeks prior to first dose.
- Current use of oral or intravenous beta-blockers (e.g., atenolol, bisoprolol, carvedilol, labetalol, metoprolol, nadolol, sotalol, etc.) that cannot be safely switched to non-beta-blocker alternatives. Current subjects should have a washout period of at least 14 days with adequate transition period.
- Contraindications to Beta-Blocker Use Hypersensitivity to any component of this product Bronchial asthma or risk of bronchospasm Ketoacidosis and metabolic acidosis Severe or symptomatic bradycardia, atrioventricular block (Grade II or III), sinoatrial block, sick sinus syndrome Cardiogenic shock Right heart dysfunction caused by pulmonary hypertension Congestive heart failure (NYHA Class III or IV) Hypotension (systolic blood pressure <100 mmHg) Prolonged fasting state Severe peripheral circulatory failure (e.g., gangrene) Symptomatic peripheral arterial disease or Raynaud's syndrome, untreated pheochromocytoma Unstable angina or Prinzmetal's angina Concurrent use of rizatriptan benzoate Severe chronic obstructive pulmonary disease (COPD) Uncontrolled Type I or Type II diabetes mellitus (glycated hemoglobin [HbA1C] >8.5 or fasting glucose >160 mg/dL at screening)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propranolol HydrochlorideAlso: InderalPropranolol hydrochloride is administered orally at three planned dose levels: 10 mg twice daily (BID), 10 mg three times daily (TID), and 20 mg twice daily (BID). Dose escalation follows a conventional 3+3 design in both study cohorts to evaluate safety, dose-limiting toxicities, and the recommended Phase II dose (RP2D). | Drug | Extensive-Stage SCLC Cohort, Resectable Early-Stage (T1-2N0M0) SCLC Cohort |
| AdebrelimabAdebrelimab is administered intravenously at a dose of 1200 mg on Day 1 of each 21-day cycle in combination with propranolol hydrochloride and platinum-etoposide chemotherapy. In the extensive-stage SCLC cohort, adebrelimab is continued as maintenance therapy for up to 2 years. In the resectable early-stage SCLC cohort, adebrelimab is administered as neoadjuvant treatment followed by postoperative therapy for up to 1 year, according to the study protocol. | Drug | Extensive-Stage SCLC Cohort, Resectable Early-Stage (T1-2N0M0) SCLC Cohort |
| ChemotherapyPlatinum-based doublet chemotherapy consists of etoposide plus either carboplatin or cisplatin. Etoposide: 100 mg/m² intravenously on Days 1-3 of each 21-day cycle. Carboplatin: AUC 5 intravenously on Day 1 of each 21-day cycle; or Cisplatin: 75 mg/m² intravenously on Day 1 of each 21-day cycle. | Drug | Extensive-Stage SCLC Cohort, Resectable Early-Stage (T1-2N0M0) SCLC Cohort |
Primary outcome
Objective Response Rate (ORR) in the Extensive-Stage SCLC Cohort
Time frame: 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.
Disease Control Rate (DCR) in the Extensive-Stage SCLC Cohort
Time frame: 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.
Incidence and Severity of Treatment-Emergent Adverse Events in the Extensive-Stage SCLC Cohort
Time frame: 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.
R0 Resection Rate in the Resectable Early-Stage SCLC Cohort
Time frame: 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.
Incidence and Severity of Treatment-Related Adverse Events and Perioperative Complications in the Resectable Early-Stage SCLC Cohort
Time frame: 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.
7 secondary outcomes
Progression-Free Survival (PFS) in the Extensive-Stage SCLC Cohort
Time frame: Through study completion, up to 24 months.
Overall Survival (OS)
Time frame: Through study completion, up to 24 months.
Pathological Complete Response (pCR) Rate in the Resectable Early-Stage SCLC Cohort
Time frame: Perioperative
Major Pathological Response (MPR) Rate in the Resectable Early-Stage SCLC Cohort
Time frame: Perioperative
Disease-Free Survival (DFS) in the Resectable Early-Stage SCLC Cohort
Time frame: Through study completion, up to 12 months.
Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: Up to 24 months
Recommended Phase II Dose (RP2D) of Propranolol Hydrochloride
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Propranolol Hydrochloride, Adebrelimab and Chemotherapy in people with Small Cell Lung Cancer (SCLC), run by Second Xiangya Hospital of Central South University at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fang Wu, MD, PhD (+86-13574858332, wufang4461@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) in the Extensive-Stage SCLC Cohort (time frame: Through study completion, up to 24 months.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.