Prospective clinical study for first-generation EGFR-TKI resistance with unknown mechanism in non-small cell lung cancer: an umbrella test based on full exon sequencing

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900021619

Enrollment

Unknown

Registered

2019-03-01

Start date

2019-05-01

Completion date

Unknown

Last updated

2019-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small cell lung cancer

Interventions

Group 1:Targeted therapy or chemotherapy

Group 2:Chemotherapy

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years old male and female; 2. Using genetic testing to identify as the first generation EGFR-TKI resistance NSCLC patients with unknown mechanism; 3. ECOG-PS 0-1; 4. At least one CT measurable lesion;5. Expected to survive for at least 3 months; 6. Peripheral blood images, liver and kidney functions are within the following permitted limits (tested within 7 days before the start of treatment): - Leukocyte(WBC) = 3.0×10^9/L or neutrophil(ANC) = 1.5×10^9/L; - Hemoglobin(HGB) = 80g/L; - Platelet(PLT) = 100×10^9/L; - Liver transaminase(AST, ALT) < 5.0×ULN; - Total bilirubin(TBIL) < 2×ULN; - CREAT < 1.5×ULN. 7. Patients of child-bearing age must take effective birth control measures; 8. Sign the informed consent. Those who meet all of the criteria above will be included in the study.

Exclusion criteria

Exclusion criteria: 1. Other pathological types of tumors except TKI resistance with unknown mechanism of advanced non-small cell lung cancer; 2. Have a history of other malignant tumors in the past 5 years, except for the cured basal cell carcinoma of the skin and carcinoma in situ of the cervix; 3. Those who are known to be allergic to the drug ingredients involved in the study; 4. Pregnant or lactating women; 5. Patients with acute infections which are difficult to control; 6. Patients with drug addiction, substance abuse, long-term alcohol abuse and AIDS. Those who meet any of the criteria above will not be included in the study.

Design outcomes

Primary

Measure	Time frame
tumor marker;OS;QOL;	—

Countries

China

Contacts

Public ContactJian Zhang

Zhujiang Hospital of Southern Medical University

blacktiger@139.com+86 13925091863

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026