Exclusion criteria
fasting blood glucose, myocardial ischemia, dysphagia,, hypercalcemia, psychiatric, human immunodeficiency virus, active infection, malignant arrhythmias, SCLC, malignant tumours, autoimmune or inflammatory disorders, HBV infection, tumour, bleeding diathesis, diabetes, hepatitis B, diverticulosis, hepatitis C, diverticulitis, coagulopathy, cirrhosis, decompensated liver disease, leptomeningeal disease, gastrointestinal resection, sarcoidosis syndrome, skin cancer, allergies
CHRONIC DIARRHOEA, CARCINOMATOUS MENINGITIS, INFLAMMATORY BOWEL DISEASE, BONE METASTASIS, MYOCARDIAL ISCHEMIA, HYPERCALCEMIA, AUTOIMMUNE DISEASE, HYPERSENSITIVITY REACTIONS, SCLC, MALIGNANT TUMOURS, DEEP VEIN THROMBOSIS, WEGENER, TUMOUR, DISEASES, BLEEDING DIATHESIS, DIABETES, HEPATITIS B, BRAIN METASTASES, DIVERTICULOSIS, TUBERCULOSIS, HEPATITIS C, CONGESTIVE HEART FAILURE, DIVERTICULITIS, COAGULOPATHY, EYE INFECTION, VIRUS, MYOCARDIAL INFARCTION, THROMBOEMBOLIC EVENT, HUMAN IMMUNODEFICIENCY VIRUS, EYE INFLAMMATION, TRANSIENT ISCHEMIC ATTACK, SYSTEMIC LUPUS ERYTHEMATOSUS, METASTATIC DISEASE, CEREBROVASCULAR ACCIDENT, SKIN CANCER, CERVICAL CARCINOMA IN SITU, ALLERGIES
Patients who meet any of the following criteria will be excluded:
patients who were diagnosed with mix SCLC or limited stage SCLC;patients who have been treated with systemic therapy;patients with inability to take oral medication, including but not limited to dysphagia, gastrointestinal resection, chronic diarrhoea and intestinal obstruction;patients with any history of radiotherapy to the chest prior to systemic therapy or planned consolidation chest radiation therapy. Radiation therapy outside of the chest for palliative care (i.e., bone metastasis) is allowed but must be completed before the first dose of the study medication;patients with major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of study drugs;patients with a history of allogeneic organ transplantation;patients who have autoimmune disease, requiring systemic treatment (systemic steroids or immunosuppressive agents);patients with active or prior documented autoimmune or inflammatory disorders, including inflammatory bowel disease, diverticulitis with the exception of diverticulosis, systemic lupus erythematosus, sarcoidosis syndrome or Wegener syndrome;patients with active infection including tuberculosis, hepatitis B virus (known positive HBV surface antigen [HbsAg] result), hepatitis C virus (HCV) or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti‐HBc] and absence of HbsAg) are eligible. Patients positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA;patients with current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion: intranasal, inhaled, topical steroids or local steroid injections (e.g., intra articular injection); systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication);patients with a history of active primary immunodeficiency;patients who are known to have symptomatic brain metastases or carcinomatous meningitis, or brain or leptomeningeal disease diagnosed by CT or MRI at the time of screening;patients with receipt of live, attenuated vaccine within 30 days prior to the first dose of study drugs;patients with metastatic disease that involves major airways or blood vessels, or centrally located mediastinal tumour masses (<30 mm from the carina) of large volume;patients with evidence of bleeding diathesis or significant coagulopathy (in absence of therapeutic anticoagulation);patients who do not have completely controlled eye inflammation or eye infection, or any condition that may lead to the above‐mentioned ocular diseases;patients with any severe and/or unable to control diseases, including:patients with interstitial lung disease;patients with blood pressure unable to be controlled ideally (systolic pressure >140 mmHg, diastolic pressure >90 mmHg);patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias (including QTc ≥450 ms [male], QTc ≥470 ms [female] and patients with Grade 1 or higher congestive heart failure; NYHA classification);patients with cirrhosis, decompensated liver disease or active hepatitis;patients with poorly controlled diabetes (fasting blood glucose >10 mmol/L);patients with serious chronic gastrointestinal conditions associated with diarrhoea;patients with urine protein ≥++, and 24‐h urinary protein excretion >1.0 g confirmed;patients with psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent;patients with uncontrolled hypercalcemia (>1.5 mmol/L calcium ion or calcium >12 mg/dL or corrected serum calcium >ULN), or symptomatic hypercalcemia requiring continued diphosphate therapy;patients with unhealed wounds or fractures;patients with arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism;patients who are known to have severe allergies (≥Grade 3) to active ingredients and any excipients of anlotinib or durvalumab;patients who have other malignant tumours (except radical cervical carcinoma in situ, non‐melanoma skin cancer, etc.) at the same time;patients who are the subjects or their sexual partners cannot or refuse to take effective contraceptive measures during the clinical trial;patients who are pregnant or breast‐feeding women; andpatients in other situations who are evaluated by the investigator to be ineligible to be enrolled.