YK-029A as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations

Inclusion Criteria:

1. Male or female adult patients (aged 18 years or older).
2. Histologically or cytologically confirmed nonsquamous cell locally advanced notsuitable for definitive therapy, recurrent, or metastatic (Stage IV) NSCLC.
3. Documented epidermal growth factor receptor (EGFR) in-frame exon 20 insertion mutationassessed by a clinical laboratory improvements amendment (CLIA)-certified (Chinasites) or an accredited (outside of the US) local laboratory.

3、The EGFR exon 20 insertion mutation can be either alone or in combination with other EGFRor human epidermal growth factor receptor 2 (HER2) mutations except EGFR mutations forwhich there are approved anti-EGFR tyrosine kinase inhibitors [TKIs] (ie, exon 19 del,L858R, T790M, L861Q, G719X, or S768I, where X is any other amino acid).

4、Adequate tumor tissue available, either from primary or metastatic sites, for centrallaboratory confirmation of EGFR exon 20 insertion mutation.

5、At least 1 measurable lesion per RECIST Version 1.1. 6、Life expectancy ≥3 months. 7、Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. 8、Adequate organand hematologic function as defined by blood transfusions with a recommended >/ 14 daywashout period.

Exclusion Criteria:

1. Received prior systemic treatment for locally advanced or metastatic disease,including local administration, such as intra-pleural injection of anticancermedication with the exception noted below.
2. Neoadjuvant or adjuvant chemotherapy/immune therapy for Stage I to III or combinedmodality chemotherapy/radiation for locally advanced disease is allowed if completed >6 months before the development of metastatic disease.
3. Received radiotherapy ≤14 days before randomization or has not recovered fromradiotherapy-related toxicities.
4. Received a moderate or strong cytochrome P450 (CYP)3A inhibitor or moderate or strongCYP3A inducer within 10 days before first dose of YK-029A.
5. Concurrent EGFR mutations: exon 19 deletion, L858R, T790M, G719X, S768I, or L861Q.
6. Have been diagnosed with another primary malignancy other than NSCLC。
7. Have current spinal cord compression or leptomeningeal disease.
8. Have uncontrolled hypertension. Participants with hypertension should be undertreatment on study entry to control blood pressure.
9. Received a live vaccine within 4 weeks before randomization per Summary of productcharacteristics (SmPCs) for pemetrexed, cisplatin, and carboplatin.
10. As judged by the investigator, any evidence of severe or uncontrolled systemicdiseases, including uncontrolled hypertension and active bleeding diatheses (i.e.,hemophilia and Von Willebrand disease).