Main inclusion criteria:

1. Male or female of age 18 and above;

2. Proved by way of histology or cytology to be late-stage non-small cell lung cancer (NSCLC) patient;  

3. ● Verified EGFR 20 Exon insertion mutation, with development of disease following chemotherapy with Carboplatin or drug intolerance;  

● Or HER2 20 Exon insertion mutation (including A775_G776insYVMA, or any other 20 Exon insertion mutation),  with development of disease following chemotherapy with Carboplatin or drug intolerance;  

● Or EGFR sensitive mutation patient who has not undergone standard treatment, including and not limited to 19 Exon deletion mutation (19del) and 21 Exon L858 mutation (L858R);


Main exclusion criteria:

Patients who meet with any of the following conditions will not be admitted into the trial:

1. Patients with EGFR mutation relating to EGFR-TKI sensitivity, with C797S mutation following previous treatment by third-generation EGFR TKI (such as Osimertinib, Almonertinib) (patients not showing C797S mutation can be admitted);

2. Have accepted treatment with EGFR 20 Exon insertion mutation or HER2 20 Exon insertion mutation kinase inhibitor (including but limited to Poziotinib, TAK-788 and other APIs or other drugs at clinical trial stage.)

3. Suffer from eptomeningeal metastasis or CNS metastasis which requires clinical intervention or epilepsy relating to malignant tumor; (Patients showing symptoms of CNS metastasis which is under control may be admitted to the trial);

4. Any serious or uncontrollable systemic disease;

5. Major cardiac disease such as arrhythmia;

6. Except for MSCLC, have been diagnosed within the past 3 years to suffer from another malignant disease which required treatment; Excluding basal-cell carcinoma and squamous-cell skin cancer which has been completely removed, or any type of ductal carcinoma in situ (DCIS) which has been completely removed;  

7. History of arterial thrombosis within six months before the first day of trial (such as stroke, transient ischemic attack (TIA) or myocardial infarction (MI));

8. Have previous history of Interstitial Lung Disease (ILD), drug-related ILD or radiation pneumonitis which required steroid treatment, or are currently under drug treatment or other clinical intervention or have existing active ILD;

9. Difficulty in swallowing or suffer from active digestive system disease, or have undergone major digestive tract surgery that may significantly affect the ingestion or absorption of PLB1004.


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