Discovery Stage IND EXEMPT Clinical Study - Etoposide and Single Nucleotide Polymorphisms

The usual approach group, after local therapy with surgery, 300 double blind random group
separated SCLC patients currently used the Combined Chemotherapy on Etoposide Injection plus
Methotrexate Injection plus Topotecan Injection, it will try to look for the relationship
between the ETOPOSIDE therapeutic efficacy and the Topoisomerase II SNP Genotyping, and the
relationship between the ETOPOSIDE therapeutic safety and the CYP4503A4 SNP Genotyping, based
on Oxford precisely sequencing drug targets' genes.

The study approach group, after local therapy with surgery, 300 double blind random group
separated SCLC patients currently used the Combined Chemotherapy on Etoposide Capsule plus
Methotrexate Tablet plus HYCAMTIN - Topotecan Capsule, it will try to look for the
relationship between the ETOPOSIDE therapeutic efficacy and the Topoisomerase II SNP
Genotyping, and the relationship between the ETOPOSIDE therapeutic safety and the CYP4503A4
SNP Genotyping, based on Oxford precisely sequencing drug targets' genes.

- 1) Detect drug target whole gene precision sequence of everyone patient for all 600
recruited double blind SCLC patients.

- 2) Mutually compare everyone patient drug target whole gene precision sequence for total
600 recruited double blind SCLC patients.

- 3) Calculate drug target gene SNPs in all 600 recruited double blind SCLC patients.

- 4) Correlate everyone patient drug target gene SNP to everyone patient drug efficacy.

- 5) Correlate everyone patient drug target gene SNP to everyone patient drug safety.

- 6) Mutually compare the usual approach group SNPs (300 double blind random group
separated SCLC patients) with the study approach group SNPs (300 double blind random
group separated SCLC patients).

- 7) Confirm the relationship between drug target gene SNPs and drug efficacy.

- 8) Confirm the relationship between drug target gene SNPs and drug safety.

- Select 800 Small-Cell Lung Cancer Patients

- Duration at least 180 days

- The usual approach group - Recruit 300 double blind random group separated SCLC
patients currently used the Combined Chemotherapy on Etoposide Injection plus
Methotrexate Injection plus Topotecan Injection after local therapy with surgery, like
as the usual approach group.

- The study approach group - Recruit 300 double blind random group separated SCLC
patients currently used the Combined Chemotherapy on Etoposide Capsule plus
Methotrexate Tablet plus HYCAMTIN - Topotecan Capsule after local therapy with
surgery, like as the study approach group.

The inclusion criteria:

- 1. Clinical diagnosis of small cell lung cancer

- 2. Clinical biopsy diagnosis of small cell lung cancer

- 3. Suitable for local therapy with surgery

- 4. Random and double blind

- 5. Measurable disease

- 6. Adequate organ functions

- 7 .Adequate performance status

- 8. Age 22 years old and over

- 9. Sign an informed consent form

- 10. Receive blood-drawing

The exclusion criteria:

- 1. Treatment with other anti-cancer therapies and cannot be stopped currently

- 2. Pregnancy

- 3. Breast-feeding

- 4. The patients with other serious inter-current illness or infectious diseases

- 5. Have more than one different kind of cancer in the same time

- 6. Serious Allergy to Lipids

- 7. Serious Bleed Tendency

- 8. The prohibition of the drug product