Squamousnon-small cell lung cancer
Conditions
Interventions
experimental group:ACC006 combined with albumin binding paclitaxel and carboplatin
control group:placebo combined with albumin binding paclitaxel and carboplatin
Sponsors
Sun Yat-Sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with age >= 18 years old, sex not limited, inpatients or outpatients; 2. Patients with locally advanced, metastatic or recurrent squamous cell lung cancer (IIIB-IV, UICC and AJCC TNM stages, 8th Edition) confirmed by histology or cytology (including non central lung squamous cell carcinoma or adenosquamous carcinoma with squamous cell carcinoma as the main component); 3. According to the criteria for evaluating the efficacy of solid tumors (RECIST, version 1.1), there should be at least one measurable tumor lesion; 4. Patients who can not receive surgical treatment and / or radical concurrent chemoradiotherapy; 5. Patients who have not previously received systemic anti-tumor therapy for locally advanced, metastatic or recurrent squamous non-small cell lung cancer (including chemotherapy, molecular targeted therapy and immunotherapy, excluding adjuvant chemotherapy or local regional therapy when the last time of administration is more than or equal to 6 months after tumor recurrence); 6. Patients with ECoG score = 12 weeks; 8. The laboratory examination meets the following standards: (1) The absolute count of neutrophils was more than 1.5 * 10 ^ 9 / L; (2) Platelet >= 100 * 10 ^ 9 / L; (3) Hemoglobin >= 90g / L; (4) Serum total bilirubin <= 1.5 * ULN; (5) ALT and AST <= 2.5 * ULN (ALT and AST <= 5 * ULN in patients with liver metastasis); (6) INR <= 1.5 * ULN (7) Serum creatinine <= 1.5 * ULN; 9. Fertile subjects (including male and female subjects) agreed to use effective contraceptive measures (such as intrauterine device, contraceptive or condom) approved by the researcher during the trial and within 3 months after the end of the trial. The serum hCG test results of the fertile female subjects within 72 hours before the study enrollment were negative; 10. Those who have signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who are known or suspected to be allergic to the components of acc006 and acc006 simulants, or have a history of severe allergy to platinum or paclitaxel preparations; 2. Patients with brain metastasis with clinical symptoms, except those without clinical symptoms or stable condition for more than 1 month after treatment; 3. Patients with positive EGFR, ALK and ros1 were known; 4. Patients with acute toxicity (CTCAE 5.0, except alopecia) caused by the previous anti-tumor treatment (surgery, radiotherapy, chemotherapy, targeting or immunotherapy) before enrollment; 5. Patients with severe renal dysfunction or end-stage renal disease; 6. Patients with absorption disorder syndrome, or any other condition affecting gastrointestinal absorption, requiring intravenous nutrition or unable to take oral drugs; 7. Combined with cardiac function damage, manifested as any of the following conditions: (1) Poorly controlled pericardial effusion (2) Severe arrhythmia; (3) Unstable angina pectoris; (4) Left ventricular ejection fraction (LVEF) was less than 45%; (5) Myocardial infarction occurred within 12 months before enrollment; (6) Have or have had congestive heart failure; (7) He had received cardiac bypass surgery before; (8) QT interval with clinical significance was prolonged (female QTc >= 470ms, male QTc >= 450ms); 8. Patients with severe hypertension or hypertensive crisis (defined as resting systolic blood pressure >= 180mmhg and / or diastolic blood pressure >= 110mmhg), or uncontrolled or uncontrollable diabetes mellitus. 9. Patients with active infection, including patients with active tuberculosis (clinical diagnosis includes clinical history, physical examination and imaging findings, and TB examination according to local medical practice), human immunodeficiency virus infection (HIV antibody positive), hepatitis B (known HBV surface antigen (HBsAg) positive and HBV DNA >= 10 ^ 3) Copies / ml), hepatitis C (known HCV antibody positive and HCV-RNA >= 10 ^ 4 copies / ml); hepatitis B and hepatitis C patients who have been controlled by antiviral treatment can participate in this study. 10. Patients with previous or present tumors other than squamous non-small cell lung cancer, including lung squamous cell carcinoma mixed with small cell carcinoma, excluding non melanoma skin cancer, cervical cancer in situ after radical treatment, or other tumors with no signs of disease after radical treatment for more than 5 years; 11. Patients with neurological and mental disorders who are unable or unwilling to cooperate; 12. Patients with suspected or confirmed history of alcohol and drug abuse; 13. According to the judgment of the researcher, patients with other conditions that are not suitable for the trial; 14. Pregnant and lactating women; 15. Patients who participated in other clinical trials within 12 weeks before administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progress-free survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR);Duration of response (DOR);Disease control rate (DCR);Pharmacokinetic parameters;Incidence of adverse events; | — |
Countries
China
Contacts
Public ContactLi Zhang
Cancer Center of Sun Yat-Sen University
Outcome results
None listed