Non-small cell lung cancer, pulmonary sarcomatoid carcinoma
Conditions
Interventions
Treatment group:Penpulimab and Anlotinib combined with Platinum-Doublet Chemotherapy
Sponsors
Nanjing Drum Tower Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed sarcomatoid carcinoma of the lung, including (but not limited to) pleomorphic carcinoma, giant cell carcinoma, spindle cell carcinoma, pulmonoblastoma, and carcinosarcoma; Patients with advanced inoperable stages of cTNM according to AJCC Version 8; 2. Patients previously untreated for NSCLC-related chemotherapy, radiotherapy, and immunotherapy, etc. Patients who have previously received adjuvant therapy , with disease progression occurring >6 months after the last treatment, may participate in this study; 3. Measurable lesions (according to RECIST 1.1 standards, the CT scan length =10mm for tumor lesions and the short CT scan diameter =15mm for lymph node lesions); 4. ECOG or PS score of 0 or 1; 5. The expected survival time is more than 3 months; 6. Age =18 years old; 7. Asymptomatic brain metastases or focal control after brain metastases radiotherapy; 8. Routine laboratory tests (blood routine, liver and kidney function, coagulation function, etc.) have no significant abnormalities: (1) The standard of blood routine examination must meet (no blood transfusion and blood products within 14 days) : ANC=1.5×10^9/L; PLT=80×10^9/L; (2) Biochemical examination shall meet the following standards: TBIL 45 ml/min (Cockcroft-Gault formula); (3) Bone marrow hematopoietic function is normal: White blood cell count =4×109/L, neutrophil count =2.0×109/L, hemoglobin count =90g/L, platelet count =100×109/L; 9. The heart, lung and other organ functions are basically normal, no serious medical diseases; 10. Reproductive-age women must agree to use contraception during the study and for 6 months after the study ends (such as intrauterine devices [IUD], contraceptive pills, or condoms); a negative serum or urine pregnancy test within 7 days before entry into the study, and must be non-lactating patients. Male patients must also agree to use contraception during the study and for 6 months after the study ends; 11. Patients must voluntarily participate in this study, sign an informed consent form, and exhibit good compliance.
Exclusion criteria
Exclusion criteria: 1.Have participated in other drug trials or other drug treatments within 4 weeks; 2.The patient has had or co-developed other malignancies within 5 years (except cured basal cell carcinoma of the skin and cervical carcinoma in situ); 3. Pregnant or lactating women; 4. A history of allergic reactions to any of the study drug components; 5. Patients had intractable pleural or pericardial effusion with poor control; 6. Patients with unsatisfactory blood pressure control (systolic pressure =150 mmHg, diastolic pressure =100 mmHg); Unstable angina pectoris, myocardial infarction, = grade 2 congestive heart failure, or arrhythmias requiring treatment (including QTc=480ms) within 6 months prior to first dosing; 7. The subject has any active autoimmune disease or history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; Subjects with vitiligo or complete remission of asthma in childhood could be included as adults without any intervention; Patients with asthma requiring medical intervention with bronchodilators were not included); 8. Receiving systemic glucocorticoid treatment or any other form of immunosuppressive therapy (dose > 10 mg/day of prednisone or equivalent) and still on therapy within 2 weeks before the first dose 9. Serious infections (CTCAE > Grade 2), such as severe pneumonia, bacteremia, and comorbiditis requiring hospitalization, occurred 4 weeks prior to the first use of the investigatory drug; Baseline chest imaging findings indicate active lung inflammation, signs and symptoms of infection within 2 weeks prior to the first use of the study drug, or the need for oral and intravenous antibiotic treatment, except in cases of prophylactic antibiotic use; 10. The subjects had acute cardiovascular and cerebrovascular diseases such as acute cerebral infarction and acute coronary syndrome within 1 month, and the cardiovascular clinical symptoms or diseases were not well controlled; 11. Patients with grade ? to ? cardiac insufficiency according to NYHA standards, or left ventricular ejection fraction (LVEF) 1.5 APTT>1.5 ULN) and bleeding tendency; 13. Patients with a clear tendency to gastrointestinal bleeding, including the following conditions: there are locally active ulcer lesions, and stool occult blood {(++) cannot be included in the group}; Patients with a history of black stool and hematemesis within 2 months; Wounds or fractures that have not healed for a long time; Have had major surgery or severe traumatic injury, fracture or ulcer within 4 weeks; 14. Have active systemic infections, including tuberculosis (clinical diagnosis including medical history, physical examination, imaging findings, and TB testing according to local medical routines), hepatitis B (known to be HBV surface antigen (HBsAg) positive, with HBV DNA =1000cps/ml or the lower limit of the reference value), hepatitis C, or human immunodeficiency virus (HIV antibody positive); 15. Patients with a history of psychotropic substance abuse who cannot abstain or who have mental disorders; 16. Being other conditions that the physician considers unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate, ORR;Disease Control Rate, DCR;Overall Survival, OS; | — |
Countries
China
Contacts
Public ContactYongsheng Wang
Nanjing Drum Tower Hospital
Outcome results
None listed