Non-small cell lung cancer
Conditions
Interventions
single arm group:Iparomlimab and Tuvonralimab
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1.Age & Sex: Male or female, aged 18 to 75 years; 2.Diagnosis: Histologically or cytologically confirmed squamous or non-squamous non-small cell lung cancer (NSCLC) (EGFR/ALK/ROS1 negative); 3.Prior Therapy: No prior local therapy (surgery or radiotherapy) or any prior systemic anti-tumor therapy for the cancer, including cytotoxic therapy, targeted therapy (including tyrosine kinase inhibitors or monoclonal antibodies), cellular therapy, immunotherapy, Chinese herbal medicine therapy, or any other investigational drug therapy; 4.Disease Stage: Stage III unresectable disease (per AJCC 8th edition NSCLC TNM staging: T1-2N2-3M0, T3N1-3M0, T4N0-3M0) as assessed by a Multidisciplinary Team (MDT); 5.Measurable Disease: At least one measurable lesion confirmed by contrast-enhanced chest CT or PET/CT according to RECIST v1.1; 6.Performance Status: ECOG performance status score of 0 or 1; 7.Treatment Tolerance & Surgical Candidacy: Patient is deemed able to tolerate induction therapy and surgery. Radical resection with systematic lymphadenectomy is recommended provided surgical margins can be achieved and considering the patient's overall condition. (Note: This criterion seems contradictory to criterion 4 defining unresectability. It may reflect specific study design nuances or potential for downstaging); 8.Life Expectancy: Estimated life expectancy >= 12 months; 9.Adequate Organ and Bone Marrow Function: Hematology (within 14 days, without transfusion or hematopoietic growth factors): (1)Absolute neutrophil count (ANC) >= 1.5 × 10^9/L;Platelets >= 100 × 10^9/L;Hemoglobin >= 90 g/L (2)Liver and Renal Function:Total bilirubin = 60 mL/min (calculated);Urinalysis: Urine protein = 2+, 24-hour urine collection must demonstrate protein 1.0 L or FEV1% > 50% Cardiac: Electrocardiogram (ECG) QTc interval <= 480 msec (calculated using Fridericia's formula). 10.Contraception:Women of reproductive potential: Must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment, must be using reliable contraception, and must agree to use adequate contraception during the trial and for 8 weeks after the last dose of study drug.Men: Must agree to use adequate contraception or be surgically sterile during the trial and for 8 weeks after the last dose of study drug; 11.Informed Consent: The subject voluntarily participates in the study, signs the informed consent form, demonstrates good compliance, and agrees to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: Patients meeting any of the following criteria will be excluded from the study: 1.Contraindications to Immunotherapy: Including chronic systemic corticosteroid use (excluding topical, inhaled, or physiologic replacement doses) or history of radiation pneumonitis; 2.Severe Hypersensitivity: History of severe hypersensitivity reaction to paclitaxel, docetaxel, platinum-based drugs, or their required premedications; 3.Unstable Systemic Diseases: Including:Active infection;Uncontrolled hypertension (systolic blood pressure >=140 mmHg or diastolic blood pressure >=90 mmHg despite optimal medical therapy);Unstable angina;Angina pectoris within the last 3 months;Liver disease requiring medication;Renal disease requiring medication;Metabolic disease requiring medication; 4.Recent Live Vaccination: Administration of a live vaccine within 28 days prior to treatment initiation; 5.Prior Oncologic Therapy: Previous treatment with radiotherapy, chemotherapy, targeted therapy, or immunotherapy for any cancer; 6.Active Autoimmune Disease: Requiring systemic treatment within the past 2 years (e.g., systemic corticosteroids or immunosuppressants). Note: Conditions like vitiligo, psoriasis not requiring systemic therapy, or hypothyroidism stable on hormone replacement therapy are generally permitted. (This interpretation aligns with standard trial practice; the Chinese text lists examples but implies systemic activity); 7.Active Infections:Active Hepatitis B virus (HBV) infection (HBsAg positive and detectable HBV DNA).Active Hepatitis C virus (HCV) infection (HCV antibody positive and detectable HCV RNA).Known history of Human Immunodeficiency Virus (HIV) infection (HIV antibody positive).Active tuberculosis (TB); 8.Active Infection Requiring Treatment: Active infection requiring systemic antimicrobial (antibacterial, antiviral, antifungal) therapy at the time of screening; 9.Transplant History: History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 10.Interstitial Lung Disease (ILD): Current ILD or history of ILD/pneumonitis requiring treatment with steroids or oxygen, or any evidence of active ILD/pneumonitis on screening imaging; 11.Psychiatric Conditions: History of substance abuse deemed clinically significant by the investigator and inability to abstain, or psychiatric illness/social situation that would limit compliance with study requirements or compromise the ability to provide informed consent. 12.Other Malignancies: History of or current other malignancy, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or superficial bladder cancer. Note: "Adequately treated" implies no evidence of recurrence; 13.Pregnancy/Breastfeeding/Contraception:Pregnant or breastfeeding women.Patients of childbearing potential unwilling or unable to use highly effective contraception methods throughout the study period and for the specified time after the last dose of study drug (as defined in the inclusion criteria); 14.Investigator Discretion: Any other condition that, in the judgment of the investigator, would compromise the patient's safety, interfere with participation in the study, or affect the interpretation of study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| MPR,major pathological response;Pathological response rate;Surgical conversion rate;18-month event-free survival rate;overall survival;Safety; | — |
Countries
China
Contacts
Public ContactMeiqi Shi
Jiangsu Cancer Hospital
Outcome results
None listed