D-1553 Tablet Versus Docetaxel Injection for KRAS G12C Mutation-positive Locally Advanced or Metastatic Non-small Cell Lung Cancer After Prior Standard Therapy Failure

Exclusion Criteria

• •Treatment with a KRAS G12C mutation inhibitor or docetaxel at any previous time;
• •NSCLC with mutations of other driver genes;
• •Symptomatic or progressive aggravation of central nervous system metastasis or cancerous meningitis. Subjects with a history of brain metastasis may be considered to be selected if they are clinically stable;
• •Patients with a previous history of epilepsy；presence of superior vena cava syndrome;
• •Cardiovascular system meets any condition:
• •1. New York Heart Association (NYHA) Heart Function Grade II and above congestive heart failure;
• •2. Severe cardiac arrhythmias requiring medical treatment;
• •3. Acute myocardial infarction, severe or unstable angina pectoris, coronary or peripheral artery bypass surgery within 6 months prior to enrollment;
• •4. Left ventricular ejection fraction (LVEF) \<50%;
• •5. QT interval (QTcF) at prolonged;
• •6. Hypertension that is not effectively controlled;
• •Subjects with stroke or other severe cerebrovascular disease within 6 months before enrollment;
• •History of deep vein thrombosis or any other serious thromboembolism within 3 months prior to enrollment;
• •History of interstitial lung disease, radiation pneumonitis, and immune-associated pneumonia previously treated with steroids, Or active non-infectious pneumonia with interstitial lung disease, radiation pneumonia, and immune-related pneumonia during the screening period, Presence of active tuberculosis, pneumoconiosis or grade 2 other type of pneumonia, or pulmonary function tests confirming severely impaired pulmonary function;
• •Severe bone damage due to tumor bone metastasis may occur at present or after randomization;
• •Active or uncontrolled serious infection (≥grade 2 infection of common toxicity criteria for adverse events (CTC AE)) or fever of unknown origin \> 38.5°C;
• •The third space effusion (including pleural effusion, abdominal effusion or pericardial effusion), poor clinical control or the need for local symptomatic treatment such as puncture and drainage;
• •Known impaired gastrointestinal (GI) function or known GI diseases that may significantly affect the absorption or metabolism of oral drugs.
• •Previous history of major surgery in the digestive tract (esophagus, gastrointestinal tract) that may alter the absorption or inability to swallow drugs in the study treatment;
• •Toxicity of previous antitumor therapy, except alopecia, pigmentation, clinically insignificant laboratory abnormalities) has not recovered to grade 1, and peripheral nerve toxicity has not recovered to grade 2 ( CTCAE v5.0);
• •Human immunodeficiency virus (HIV) antibody positive, liver cirrhosis or active viral hepatitis;
• •Active syphilis;
• •Patients with renal failure requiring hemodialysis or peritoneal dialysis;
• •Poor diabetes control \[fasting blood glucose (FBG)\> 10 mmol/L\];
• •Previous history of organ transplantation or readiness to undergo organ transplantation;
• •Weight of \<40 kg and BMI of \<18.5 kg/m2, or weight loss of\> 5% within 3 months before enrollment;
• •Major surgical treatment or significant traumatic injury within 4 weeks prior to the first dose of this study;
• •Receiving palliative radiotherapy with local lesions within 2 weeks before the first dose of this study;
• •Pregnant or lactating subjects;
• •With the combination of other primary malignancies
• •Serious mental or mental illness or history of substance abuse or serious alcohol abuse;
• •Known allergy to the investigational medicinal product or any ingredient in the formulation;
• •Any other significant clinical abnormality or disease that the investigator considers poses a risk to subject safety or interferes with the medication and evaluation of the clinical study.