Resectable Non-Small-Cell Lung CancerPhase 1NeoBRIONCT07886229
Propranolol Hydrochloride Combined With Toripalimab and Platinum-based Chemotherapy in Resectable Non-Small Cell Lung Cancer
A Phase 1 study testing Propranolol Hydrochloride, Toripalimab and Chemotherapy in people with Resectable Non-Small-Cell Lung Cancer, run by Second Xiangya Hospital of Central South University at 4 sites in China.
Trial summary
This is a prospective, multicenter, open-label study designed to evaluate the safety and tolerability of propranolol hydrochloride in combination with toripalimab and platinum-based chemotherapy as perioperative treatment in patients with resectable non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Resectable Non-Small-Cell Lung Cancer
- What is being tested?
- Propranolol Hydrochloride, Toripalimab 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
- 9 participants
- Where
- 4 sitesChina
- Study dates
- 1 Jun 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
- Sign a written informed consent form before any research-related procedures；
- Age ≥ 18 years and ≤ 75 years；
- ECOG PS score 0-1；
- Have self-awareness, be willing and have the ability to complete the questionnaire (stress score for all patients)；
- Provide a signed and dated written informed consent form before any mandatory research-specific procedures, sample collection and analysis；
- Histologically or cytologically confirmed operable stage II-IIIB (N2) non-small cell lung cancer (AJCC 9th edition TNM lung cancer staging）；
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- Requires MDT assessment for the feasibility of radical surgery；
- No previous anti-tumor treatment, and histological specimens confirmed no EGFR gene sensitive mutations, ALK gene fusion or ROS1 gene fusion；
- According to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1 version), at least one measurable lesion by imaging. Lesions located within the previous radiotherapy field can be considered measurable if progression is confirmed (within 28 days before the first treatment)；
- Agree to undergo standard lobectomy/systemic lymph node dissection；
- Meet the following laboratory indicators (14 days before the first treatment): 1) Blood routine: Absolute neutrophil count ≥ 1.5 × 109/L；Platelet count ≥ 100 × 109/L；Hemoglobin content ≥ 9.0 g/dL (no blood transfusion or no erythropoietin-dependent administration within 7 days). 2) Liver function: Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN)；No liver metastasis；Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN. For patients with liver metastasis, ALT or AST ≤ 5 × ULN. 3) Kidney function: Serum creatinine (Cr) ≤ 1.5 × ULN or Cr clearance rate ≥ 60 mL/min (Cockcroft-Gault formula), and urine routine test shows urine protein (UPRO) < 2+ or 24-hour urine protein quantification < 1 g. 4) Coagulation function: Within 7 days before the study treatment, International Normalized Ratio (INR) ≤ 1.5 × ULN or Prothrombin Time (PT) ≤ 1.5 × ULN；if the subject is receiving anticoagulation treatment, as long as the PT is within the range of the anticoagulant drug, it is acceptable；
- Cardiac function: American Heart Association (NYHA) classification < 3；Left ventricular ejection fraction ≥ 50%；Baseline electrocardiogram shows no PR interval prolongation or atrioventricular block；
- For pregnant women of reproductive age, a urine or serum pregnancy test should be performed 3 days before the first administration of the study drug (day 1 of the 1st cycle) and the result should be negative. If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Non-reproductive-aged women are defined as those who have been postmenopausal for at least 1 year, or have undergone surgical sterilization or hysterectomy；If there is a risk of conception, all subjects (regardless of male or female) should use contraceptive measures with an annual failure rate of less than 1% throughout the treatment period until 120 days (or 180 days after the last administration of the study drug) after the last administration of the 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).
- 166.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.
- 17. 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.
- 18. 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).
- 19. Bone metastases with risk of paraplegia. 20. 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).
- 21.Known active tuberculosis. 22. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- 23.Known history of human immunodeficiency virus (HIV) infection (i.e., HIV antibody positive).
- 24. 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).
- 25.Active syphilis infection requiring treatment. 26. Interstitial lung disease requiring corticosteroid therapy. 27. Active or poorly controlled severe infection. 28. 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.
- 29.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.
- 30.Pregnant or lactating female patients. 31.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, China 410011
Fang Wu, MD, PhD, +86-13574858332, 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: A Prospective, Multicenter, Open-Label Study of Propranolol Hydrochloride in Combination With Toripalimab and Platinum-Based Chemotherapy as Perioperative Treatment for Resectable Non-Small Cell Lung Cancer
This is a prospective, multicenter, open-label study designed to evaluate the safety and tolerability of propranolol hydrochloride in combination with toripalimab and platinum-based chemotherapy as perioperative treatment in patients with resectable non-small cell lung cancer (NSCLC). 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 resectable NSCLC.
- Conditions
- Resectable Non-Small-Cell Lung Cancer
- Being tested
- Propranolol Hydrochloride, Toripalimab, Chemotherapy
- Keywords
- Non-Small Cell Lung Cancer, Resectable NSCLC, Propranolol, Beta-Adrenergic Blocker, Toripalimab, Immune Checkpoint Inhibitor, Perioperative Therapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propranolol HydrochlorideDrug
Also called Inderal
Oral propranolol hydrochloride will be administered at escalating dose levels using a conventional 3+3 dose-escalation design. Three planned dose levels are 10 mg BID, 10 mg TID and 20 mg BID. Propranolol will be administered in combination with neoadjuvant toripalimab and platinum-based chemotherapy, followed by postoperative maintenance treatment with propranolol and toripalimab.
ToripalimabDrug
Also called JS001
Toripalimab will be administered intravenously at a dose of 240 mg on Day 1 of each 21-day cycle, in combination with propranolol hydrochloride and platinum-based chemotherapy for 3-4 neoadjuvant cycles. Following surgical resection, toripalimab will be continued as postoperative maintenance therapy according to the study protocol.
ChemotherapyDrug
Also called Platinum-Based Doublet Chemotherapy
Participants will receive platinum-based doublet chemotherapy selected according to tumor histology. For nonsquamous NSCLC, chemotherapy will consist of pemetrexed in combination with cisplatin or carboplatin. For squamous NSCLC, chemotherapy will consist of a taxane (paclitaxel, nab-paclitaxel, liposomal paclitaxel, paclitaxel polymeric micelles, or docetaxel) in combination with cisplatin or carboplatin. Chemotherapy will be administered intravenously every 3 weeks for 3-4 neoadjuvant cycles, in combination with propranolol hydrochloride and toripalimab, followed by multidisciplinary evaluation for surgical resection.
| Study group | Role | What they receive |
|---|---|---|
| Propranolol Plus Toripalimab and Platinum-Based Chemotherapy | Experimental | Patients will receive propranolol hydrochloride in combination with toripalimab and platinum-based chemotherapy as neoadjuvant treatment for 3-4 cycles, followed by multidisciplinary evaluation for surgical resection. A conventional 3+3 dose-escalation design will be used to evaluate three dose levels of oral propranolol hydrochloride (10 mg BID, 10 mg TID, and 20 mg BID) to determine the recommended Phase II dose (RP2D). Following surgery, patients will receive postoperative maintenance treatment with propranolol hydrochloride and toripalimab according to the study protocol. Receives: Drug: Propranolol Hydrochloride; Drug: Toripalimab; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose-Limiting Toxicities (DLTs)
The number and percentage of participants experiencing dose-limiting toxicities at each propranolol dose level during the protocol-defined DLT assessment period. DLTs will be used to guide dose escalation in the conventional 3+3 design.
Measured: Day 1 through Day 21
Incidence and Severity of Adverse Events (AEs)
The number and percentage of participants experiencing adverse events (AEs), treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and immune-related adverse events (irAEs). Severity 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 12 months
Secondary outcomes (4)
Recommended Phase II Dose (RP2D) of Propranolol
The recommended Phase II dose of propranolol hydrochloride in combination with toripalimab and platinum-based doublet chemotherapy, determined based on the safety, tolerability, and DLT findings during Phase Ib dose escalation.
Measured: Through study completion, up to 12 months
Pathological Complete Response (pCR) Rate
The percentage of participants achieving pathological complete response, defined as the absence of residual viable tumor cells in both the primary tumor bed and sampled regional lymph nodes following neoadjuvant treatment, as determined by pathological examination of surgical specimens.
Measured: Perioperative
Major Pathological Response (MPR) Rate
The percentage of participants achieving major pathological response, defined as 10% or less residual viable tumor cells in the primary tumor bed following neoadjuvant treatment, regardless of residual viable tumor cells in regional lymph nodes.
Measured: Perioperative
Objective Response Rate (ORR)
The percentage of participants achieving a complete response (CR) or partial response (PR), as assessed by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
Measured: Up to 6 months
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 start1 Jun 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 Resectable Non-Small-Cell Lung CancerStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Junshi Bioscience Co., Ltd.
- Responsible party
- Principal investigator, Fang Wu, Second Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07886229
- Sponsor's protocol ID
- LYG20260084
- Acronym
- NeoBRIO
- Status last verified
- Oct 2026
- First submitted
- 12 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
- A Prospective, Multicenter, Open-Label Study of Propranolol Hydrochloride in Combination With Toripalimab and Platinum-Based Chemotherapy as Perioperative Treatment for Resectable Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07886229
- Acronym / sponsor ID
- NeoBRIO / LYG20260084
- Conditions
- Resectable Non-Small-Cell Lung Cancer
- Keywords
- Non-Small Cell Lung Cancer, Resectable NSCLC, Propranolol, Beta-Adrenergic Blocker, Toripalimab, Immune Checkpoint Inhibitor, Perioperative Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Second Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Collaborators
- Shanghai Junshi Bioscience Co., Ltd.
- Study start
- 1 Jun 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 study designed to evaluate the safety and tolerability of propranolol hydrochloride in combination with toripalimab and platinum-based chemotherapy as perioperative treatment in patients with resectable non-small cell lung cancer (NSCLC). 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 resectable NSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Propranolol Plus Toripalimab and Platinum-Based Chemotherapy | Experimental | Drug: Propranolol Hydrochloride, Drug: Toripalimab, Drug: ChemotherapyPatients will receive propranolol hydrochloride in combination with toripalimab and platinum-based chemotherapy as neoadjuvant treatment for 3-4 cycles, followed by multidisciplinary evaluation for surgical resection. A conventional 3+3 dose-escalation design will be used to evaluate three dose levels of oral propranolol hydrochloride (10 mg BID, 10 mg TID, and 20 mg BID) to determine the recommended Phase II dose (RP2D). Following surgery, patients will receive postoperative maintenance treatment with propranolol hydrochloride and toripalimab according to the study protocol. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Sign a written informed consent form before any research-related procedures；
- Age ≥ 18 years and ≤ 75 years；
- ECOG PS score 0-1；
- Have self-awareness, be willing and have the ability to complete the questionnaire (stress score for all patients)；
- Provide a signed and dated written informed consent form before any mandatory research-specific procedures, sample collection and analysis；
Key exclusion criteria (25 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: InderalOral propranolol hydrochloride will be administered at escalating dose levels using a conventional 3+3 dose-escalation design. Three planned dose levels are 10 mg BID, 10 mg TID and 20 mg BID. Propranolol will be administered in combination with neoadjuvant toripalimab and platinum-based chemotherapy, followed by postoperative maintenance treatment with propranolol and toripalimab. | Drug | Propranolol Plus Toripalimab and Platinum-Based Chemotherapy |
| ToripalimabAlso: JS001Toripalimab will be administered intravenously at a dose of 240 mg on Day 1 of each 21-day cycle, in combination with propranolol hydrochloride and platinum-based chemotherapy for 3-4 neoadjuvant cycles. Following surgical resection, toripalimab will be continued as postoperative maintenance therapy according to the study protocol. | Drug | Propranolol Plus Toripalimab and Platinum-Based Chemotherapy |
| ChemotherapyAlso: Platinum-Based Doublet ChemotherapyParticipants will receive platinum-based doublet chemotherapy selected according to tumor histology. For nonsquamous NSCLC, chemotherapy will consist of pemetrexed in combination with cisplatin or carboplatin. For squamous NSCLC, chemotherapy will consist of a taxane (paclitaxel, nab-paclitaxel, liposomal paclitaxel, paclitaxel polymeric micelles, or docetaxel) in combination with cisplatin or carboplatin. Chemotherapy will be administered intravenously every 3 weeks for 3-4 neoadjuvant cycles, in combination with propranolol hydrochloride and toripalimab, followed by multidisciplinary evaluation for surgical resection. | Drug | Propranolol Plus Toripalimab and Platinum-Based Chemotherapy |
Primary outcome
Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: Day 1 through Day 21
The number and percentage of participants experiencing dose-limiting toxicities at each propranolol dose level during the protocol-defined DLT assessment period. DLTs will be used to guide dose escalation in the conventional 3+3 design.
Incidence and Severity of Adverse Events (AEs)
Time frame: Through study completion, up to 12 months
The number and percentage of participants experiencing adverse events (AEs), treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and immune-related adverse events (irAEs). Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
4 secondary outcomes
Recommended Phase II Dose (RP2D) of Propranolol
Time frame: Through study completion, up to 12 months
Pathological Complete Response (pCR) Rate
Time frame: Perioperative
Major Pathological Response (MPR) Rate
Time frame: Perioperative
Objective Response Rate (ORR)
Time frame: Up to 6 months
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, Toripalimab and Chemotherapy in people with Resectable Non-Small-Cell Lung Cancer, 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 13 inclusion and 25 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 (+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?
Incidence of Dose-Limiting Toxicities (DLTs) (time frame: Day 1 through Day 21). The study lists 2 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.