Non-small cell lung cancer
Conditions
Interventions
Single Arm:Apatinib 5mg/kg intravenous infusion (30-60 minutes), once every 21 days until disease progression, intolerable toxicity, or study termination
combined with Gemcitabine 1000mg/m2 intravenous infusion (30 minutes), administered on days 1 and 8 of each 21-day cycle, for a total of 4-6 cycles.
Sponsors
Qingdao Central Hospital, University of Health and Rehabilitation Sciences (Qingdao Central Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign the informed consent form; 2. Age >=18 years, male or female; 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0–2; 4. Histologically confirmed advanced squamous non-small cell lung cancer (AJCC 9th Edition Lung Cancer TNM Staging); 5. Confirmed negative for driver gene mutations by genetic testing; 6. Patients who have received prior first-line systemic therapy and have experienced treatment failure with anti-PD-1/PD-L1 immunotherapy; 7. Presence of at least one measurable lesion as defined by RECIST version 1.1; 8. Life expectancy >=12 weeks; 9. Adequate organ function: (1) Hematology: 1) Hemoglobin (HB) =80 g/L; 2) Absolute neutrophil count (ANC) >=1.5×10^9/L; 3) Platelet count (PLT) >=75×10^9/L; (2) Blood biochemistry: 1) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =28 g/L; 4) Serum creatinine (Cr) =45 mL/min (calculated using the Cockcroft-Gault formula); 10. Female patients of childbearing potential must agree to use contraception during the study and for 6 months after the end of the study; must have a negative serum or urine pregnancy test within 7 days prior to enrollment, and must not be breastfeeding; male patients must agree to use contraception during the study and for 6 months after the study; 11. Good compliance, ability to undergo treatment and follow-up, and willingness to adhere to the study protocol.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria are not eligible for participation in this study: 1. Prior treatment with anti-PD-1/PD-L1 combined with anti-CTLA-4 dual immunotherapy, or with PD-1/CTLA-4 bispecific antibody therapy; 2. Prior treatment with gemcitabine; 3. Patients with symptomatic brain metastases, carcinomatous meningitis, or spinal cord compression, or with evidence of brain or leptomeningeal disease on screening imaging (CT or MRI). (Patients with brain metastases who have completed treatment and are stable without progression for 4 weeks prior to enrollment may be eligible); 4. History of other malignancies (except for curatively treated cervical carcinoma in situ, basal cell carcinoma of the skin, or other malignancies curatively treated >5 years ago); 5. Presence of other severe concomitant diseases, including but not limited to: uncontrolled congestive heart failure (NYHA Class III or IV), unstable angina pectoris, poorly controlled arrhythmia, uncontrolled moderate to severe hypertension (SBP >160 mmHg or DBP >100 mmHg), severe active infection, poorly controlled diabetes mellitus (defined as wide glycemic fluctuations despite standard insulin therapy and frequent glucose monitoring, affecting daily life and with frequent hypoglycemia); 6. Known allergy to any study drug or its components; 7. Active autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism; including but not limited to these diseases or syndromes). Exceptions include: autoimmune hypothyroidism on a stable dose of thyroid replacement hormone; type 1 diabetes mellitus on a stable dose of insulin; vitiligo; or childhood asthma/allergy that has resolved and requires no intervention in adulthood; 8. History of immunodeficiency, including a positive HIV test, other acquired or congenital immunodeficiency diseases, or history of organ transplantation or allogeneic bone marrow transplantation; 9. Untreated chronic hepatitis B, or chronic hepatitis B virus (HBV) DNA >2000 IU/mL, or active hepatitis C virus (HCV) infection. Patients who are inactive hepatitis B surface antigen carriers, treated and stable hepatitis B patients (HBV DNA 1 year prior to enrollment without having received standard treatment; 11. Pregnant (confirmed by serum or urine HCG test) or breastfeeding women; or fertile participants (male and female) unwilling or unable to use effective contraception for at least 6 months after the last dose of study treatment; 12. Any condition deemed by the investigator to make the patient ineligible for participation, such as a high probability of inability to comply with study procedures, restrictions, and requirements, or other circumstances determined at the investigator's discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival, OS;Objective response rate, ORR;Disease Control Rate, DCR;Duration of Response, DoR; | — |
Countries
China
Contacts
Public ContactZhang Zhen
Qingdao Central Hospital, University of Health and Rehabilitation Sciences (Qingdao Central Hospital)
Outcome results
None listed