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

Inclusion Criteria:

• Voluntary participation in the study and sign of written informed consent after fullinformed consent, willing and able to comply with the study procedures andrequirements specified in the protocol;
• Age greater than or equal to 18 years old; male and female; eastern cooperativeoncology group performance status (ECOG) score 0-1; expected survival period greaterthan or equal to 3 months;
• Pathologically confirmed locally advanced, unresectable and / or metastatic non-smallcell lung cancer (stage III b / III c / IV of american joint committee on cancer (AJCC) 8th);
• Subjects must provide adequate and qualified tumor tissue specimens (surgicalresection samples or puncture / biopsy tissue samples within 2 years prior toscreening) for confirmation of the KRAS G12C mutation in the central laboratory;
• Disease progression or toxicity after previous treatment with first-line anti-PD-1 /PD-L1 and platinum-containing chemotherapy is not tolerated.Subjects who have clearmedical reasons and can not tolerate anti-PD-1 / PD-L1 therapy or platinum-containingchemotherapy;
• Having at least one target lesion according to RECIST 1.1;
• Good function of the major organs;
• Female subjects of childbearing age should agree that contraception must be usedduring the study and within 6 months after the end of the study; the serum pregnancytest is negative within 7 days before study enrollment and must be non-lactatingsubjects; male subjects should agree that contraception must be used during the studyand within 6 months after the end of the study period.

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 orcancerous meningitis. Subjects with a history of brain metastasis may be considered tobe 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 congestiveheart failure;
2. Severe cardiac arrhythmias requiring medical treatment;
3. Acute myocardial infarction, severe or unstable angina pectoris, coronary orperipheral 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 beforeenrollment;
• History of deep vein thrombosis or any other serious thromboembolism within 3 monthsprior to enrollment;
• History of interstitial lung disease, radiation pneumonitis, and immune-associatedpneumonia previously treated with steroids, Or active non-infectious pneumonia withinterstitial lung disease, radiation pneumonia, and immune-related pneumonia duringthe screening period, Presence of active tuberculosis, pneumoconiosis or grade 2 othertype of pneumonia, or pulmonary function tests confirming severely impaired pulmonaryfunction;
• Severe bone damage due to tumor bone metastasis may occur at present or afterrandomization;
• Active or uncontrolled serious infection (≥grade 2 infection of common toxicitycriteria for adverse events (CTC AE)) or fever of unknown origin > 38.5°C;
• The third space effusion (including pleural effusion, abdominal effusion orpericardial effusion), poor clinical control or the need for local symptomatictreatment such as puncture and drainage;
• Known impaired gastrointestinal (GI) function or known GI diseases that maysignificantly affect the absorption or metabolism of oral drugs. Previous history of major surgery in the digestive tract (esophagus, gastrointestinaltract) that may alter the absorption or inability to swallow drugs in the study treatment;
• Toxicity of previous antitumor therapy, except alopecia, pigmentation, clinicallyinsignificant laboratory abnormalities) has not recovered to grade 1, and peripheralnerve toxicity has not recovered to grade 2 ( CTCAE v5.0);
• Human immunodeficiency virus (HIV) antibody positive, liver cirrhosis or active viralhepatitis;
• 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 organtransplantation;
• Weight of <40 kg and BMI of <18.5 kg/m2, or weight loss of> 5% within 3 months beforeenrollment;
• Major surgical treatment or significant traumatic injury within 4 weeks prior to thefirst dose of this study;
• Receiving palliative radiotherapy with local lesions within 2 weeks before the firstdose 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 alcoholabuse;
• Known allergy to the investigational medicinal product or any ingredient in theformulation;
• Any other significant clinical abnormality or disease that the investigator considersposes a risk to subject safety or interferes with the medication and evaluation of theclinical study.