Non small cell lung cancer
Conditions
Interventions
Treatment group:Eligible participants will receive carboplatin (AUC 5) on day 1 and albumin-bound paclitaxel (130 mg/m2) on days 1 and 8 of each cycle. On day 8, an injection of a PD-1 monoclonal anti
Sponsors
the First Affiliated Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Participants eligible for inclusion in the study must meet all of the following criteria: 1) Voluntary provision of written informed consent. 2) Age =18 years at the time of enrollment, both males and females are eligible. 3) An Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. 4) An expected survival of =3 months. 5) Histologically or cytologically confirmed, locally advanced (stage IIIB/IIIC) or metastatic (stage IV) squamous non-small cell lung cancer (NSCLC) that is not amenable to curative treatment (complete surgical resection, concurrent/sequential chemoradiotherapy) according to the 8th edition of the TNM staging system by the International Union Against Cancer and the American Joint Committee on Cancer. Patients with mixed histology (e.g., adenosquamous carcinoma) are eligible if a squamous component is present. 6) No prior systemic anticancer therapy for locally advanced or metastatic squamous NSCLC. Patients who have received neoadjuvant/adjuvant therapy or curative concurrent/sequential chemoradiotherapy are eligible if the metastasis occurs at least 12 months after the last treatment; if progression occurs within 6 months after the last treatment and is considered for first-line treatment, they are also eligible. 7) At least one measurable lesion according to RECIST v1.1, which is suitable for accurate repeated measurements. 8) Adequate organ function established by the following criteria: a) Hematology (no blood component and growth factor support within 7 days before starting study treatment): i. Absolute Neutrophil Count (ANC) = 1.5 × 10^9/L (1,500/mm^3); ii. Platelet Count (PLT) = 100 × 10^9/L (100,000/mm^3); iii. Hemoglobin = 90 g/L. b) Renal: i. Calculated Creatinine Clearance (CrCl) = 50 mL/min using the Cockcroft-Gault formula: CrCl (mL/min) = {(140 - age) × weight (kg) × F} / (SCr (mg/dL) × 72), where F = 1 for males and 0.85 for females; SCr = serum creatinine. ii. Urine protein = 2+ or 24-hour urine protein quantification < 1.0 g. c) Liver: i. Total Bilirubin (TBil) = 1.5 × Upper Limit of Normal (ULN); for patients with liver metastases or confirmed/suspected Gilbert’s Syndrome, TBil = 3 × ULN; ii. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) = 2.5 × ULN; for subjects with liver metastasis, AST and ALT = 5 × ULN. d) Coagulation: International Normalized Ratio (INR), Activated Partial Thromboplastin Time (APTT), and Prothrombin Time (PT) = 1.5 × ULN. e) Cardiac: Left Ventricular Ejection Fraction (LVEF) = 50%. 9) Female participants of childbearing potential must have a negative urine or serum pregnancy test within 3 days prior to the first dose of study medication. If urine test is not confirmatory, a serum test will be required. Female participants must agree to use acceptable contraceptive methods starting at screening and continue through 180 days after the last dose of study medication. 10) Male participants with female partners of childbearing potential must agree to use effective contraception from screening through 180 days after the last dose of study medication. 11)Participants must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Exclusion criteria
Exclusion criteria: Exclusion criteria include any of the following: 1) Histologically confirmed non-squamous NSCLC. Note: Mixed tumors will be classified according to the predominant cell type; entry is prohibited if there is a component of small cell carcinoma; however, the presence of any squamous component (e.g., adenosquamous carcinoma) permits inclusion, even if it is not the predominant component.) 2) Presence of EGFR activating mutations, ALK gene rearrangements, known ROS1 rearrangements, MET exon 14 skipping mutations, or positive RET gene fusions in squamous NSCLC; or other driver mutations for which approved first-line targeted therapies are available. 3) History of other malignancies within 5 years prior to enrollment, except for those locally treated and considered cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or in situ carcinoma of the cervix or breast. 4) Concurrent enrollment in another clinical study, unless it is an observational, non-interventional study or the follow-up period of an interventional study. 5) Receipt of more than 30 Gy of thoracic radiotherapy within 6 months before the first dose; palliative local treatment to non-target lesions within 2 weeks before the first dose; nonspecific immunomodulatory treatment (such as interleukins, interferons, thymosin, tumor necrosis factors, excluding IL-11 for thrombocytopenia) within 2 weeks before the first dose; or herbal or traditional Chinese medicines with anti-tumor indications within 1 week before the first dose. 6) Previous immunotherapy, including immune checkpoint inhibitors (e.g., anti-PD-1/L1 antibodies, anti-CTLA-4 antibodies, anti-TIGIT antibodies, anti-LAG3 antibodies), immune checkpoint agonists (e.g., antibodies against ICOS, CD40, CD137, GITR, OX40), or any immunocellular therapies targeting tumor immunity mechanisms. Note: Participants who previously received PD-1/L1 inhibitors in the neoadjuvant/adjuvant or consolidation phase after radical chemoradiotherapy may be eligible if disease progression occurred more than 12 months after the last treatment, subject to sponsor's approval. 7) Prior treatment with chemotherapy and PD-1/L1 inhibitors, or other systemic anti-tumor therapies. 8) Active autoimmune diseases requiring systemic treatment within the past two years (treatment aimed at inducing disease remission, corticosteroids, immunosuppressants). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered systemic treatment. 9) Active or a known history of inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis, or chronic diarrhea). 10) History of immunodeficiency; positive HIV antibody test; current long-term use of systemic corticosteroids or other immunosuppressive agents. 11) Known active pulmonary tuberculosis (TB), participants suspected of having active TB must be excluded through clinical assessment; known active syphilis infection. 12) History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 13) Past or present non-infectious pneumonia/interstitial lung disease requiring systemic corticosteroid treatment. 14) Serious infections occurring within 4 weeks prior to the first dose, including but not limited to complications requiring hospitalization, septicemia, or severe pneumonia; active infections treated with systemic anti-infective agents within 2 weeks prior to the first do
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR;DOR;DCR;iPFS;iORR; | — |
Countries
China
Contacts
Public ContactJian Liu/Zheng Yulong
the First Affiliated Hospital, Zhejiang University School of Medicine
Outcome results
None listed