non-small cell lung cancer
Conditions
Interventions
experimental group:ACC006 Oral Solution and Tislelizumab Injection
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. 2. Patients with locally advanced, metastatic or recurrent non small cell lung cancer confirmed by histology or cytology (IIIB-IV, AJCC 8th Edition). 3.Previous first-line or second-line standard treatment failure or intolerance (chemotherapy and immunotherapy used alone or in combination); If patient have received anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody treatments, they must have not received other systemic treatment plans after the treatment ends; previous adjuvant/neoadjuvant chemotherapy and concurrent chemoradiation are allowed in the early stage, If disease recurrence or metastasis occurs during adjuvant/neoadjuvant chemotherapy and concurrent chemoradiation, or within 6 months after completion, adjuvant/neoadjuvant chemotherapy and concurrent chemoradiation are considered to be first-line systemic chemotherapy for advanced diseases and treatment failure. 4. At least one measurable lesion, according to RECIST 1.1 standard. 5. ECOG score = 1.5 x 10^9/L; (b)PLT >= 100 x 10^9/L; (c)Hb >= 90g/L; (d)TBIL <= 1.5 x ULN; (e)AST and ALT <= 2.5 x ULN (For patients with liver metastasis, AST and ALT <= 5 x ULN); (f)INR <= 1.5 x ULN; (g)SCr <= 1.5 x ULN. 8. Patients of childbearing potential (including male and female subjects) must agree to use investigator recognized and effective contraceptive measures (such as IUD, contraceptives or condoms) during the study period and within 3 months after the study; Female fertile subjects must carry out the serum pregnancy test within 72 hours before the start of study medication, and the result is negative. 9. Signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Known or suspected hypersensitivity to the ingredients of ACC006 and monoclonal antibodies. 2.Patients with clinical symptoms of brain metastases (Patients with brain metastases who have no clinical symptoms or whose condition has been stable for more than 1 month after treatment and currently do not need glucocorticoid therapy can participate in this study). 3.Patients with known positive cancer driver genes(EGFR,ALK,ROS1), patients with squamous cell carcinoma are not required to be tested. 4.Pathological diagnosis confirmed the presence of small cell lung cancer. 5.Received the following treatments: received systemic anti-tumor therapy, such as chemotherapy, targeted therapy, immunotherapy (including Chinese herbal medicine with anti-tumor indications) within 3 weeks before enrollment; received any investigational drug treatment within 4 weeks before enrollment; received high-dose immunosuppressive drugs (systemic glucocorticoid exceeding 10 mg/day prednisone or its equivalent dose) within 4 weeks before enrollment; received reduction live virus vaccine within 4 weeks before enrollment (or plan to receive live attenuated vaccine during the study period); received major surgery (such as open cavity, open chest or open surgery) within 4 weeks before enrollment, or unhealed surgical wounds, ulcers or fractures. 6.Have not fully recovered from the toxicity (CTCAE v5.0 Grade >= 2, except for fatigue or alopecia) caused byprior anti-tumor therapy (surgery, radiotherapy, chemotherapy, targeted therapy or immunotherapy) before starting treatment. 7.Patients with active autoimmune diseases (congenital or acquired), such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, thyroiditis, etc. (Vitiligo or childhood asthma has been completely relieved patients who do not need any intervention in adulthood can participate in this study; patients with hypothyroidism who only need hormone replacement therapy and type 1 diabetes with good insulin control can participate in this study). 8.Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation. 9.With a history of idiopathic pulmonary fibrosis, organizing pneumonia (such as bronchiolitis obliterans), drug-induced pneumonia, idiopathic pneumonia, or evidence of active pneumonia on chest CT scan. 10.Patients with malabsorption syndrome, or any other conditions that affect gastrointestinal absorption, require intravenous nutrition or cannot take the medicine orally. 11.Clinically uncontrollable fluid in the third space, such as pleural fluid and ascites that cannot be controlled by drainage or other methods before enrollment. 12.Patients with impaired cardiac function, including any of the following conditions: Poorly controlled pericardial effusion; serious cardiac arrhythmia; unstable angina; left ventricular ejection fraction (LVEF) = 470ms for woman, QTc >= 450ms for man). 13.Uncontrolled severe hypertension or hypertensive crisis treated with two or more antihypertensive drugs (systolic blood pressure >= 180mmHg and/or diastolic blood pressure >= 110 mmHg), or uncontrolled diabetes. 14.Patients with active infections, including active tuberculosis(clinical diag
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose limited toxicity (DLT); | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events;Objective response rate (ORR);Progress-free survival (PFS);Duration of response (DOR);Disease control rate (DCR);Pharmacokinetic parameters; | — |
Countries
China
Contacts
Public ContactWenfeng Fang
Sun Yat-Sen University Cancer Center
Outcome results
None listed