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A randomized controlled, double-blind study of Chinese medicine combined with EGFR-TKI in the treatment of stage IV EGFR mutation-positive non-small cell lung cancer

A randomized controlled, double-blind study of Chinese medicine combined with EGFR-TKI in the treatment of stage IV EGFR mutation-positive non-small cell lung cancer

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900026748
Enrollment
Unknown
Registered
2019-10-20
Start date
2019-12-02
Completion date
Unknown
Last updated
2021-06-07

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

Sponsors

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 74 Years

Inclusion criteria

Inclusion criteria: (1) Pathological or cytological diagnosis of stage IV lung cancer with tumor patients; (2) EGFR gene mutations, including exon 19 deletion mutation (19DEL), exon 21 point mutation (21L858R), 18 exon G719X, 20 exon S768I and 21 exon L861Q mutation are also sensitive Sexual mutation, T790M mutation. (3) Aged >= 18 years; (4) The estimated survival period is >= 3 months; (5) The subject has no major organ dysfunction. Blood routine, liver, kidney, and cardiac function are normal: hemoglobin >= 120g / L, absolute neutrophil count (ANC) >= 1.5 x 10^9 / L, platelet >= 80 x 10^9 / L, bilirubin <= 1.5ULN, alkaline phosphatase (AP), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5 x ULN. INR <= 1.5, creatinine <= 1.5ULN.

Exclusion criteria

Exclusion criteria: (1) Have a history of other tumors within 5 years; (2) T790M mutation carrying 20 exons, intended to be treated with EGFR-TKI first-generation drugs; (3) Those with an expected life expectancy of level II in NYHA cardiac function. Patients with unstable angina (symptoms of angina at rest) or newly occurring angina (starting in the past 3 months) or myocardial infarction occurred in the past 6 months. Active infection, > Level 2 adverse events (CTC AE. Version 4.0); (6) Pregnant or lactating patients; (7) People with a history of mental illness that is difficult to control.

Design outcomes

Primary

MeasureTime frame
Progression free survival;

Secondary

MeasureTime frame
TTP clinical progression pattern stratification;blood routine;stool routine;urine routine;liver function;renal function;FACT-L;LCSS;objective response rate;TCM syndrome evaluation;

Countries

China

Contacts

Public ContactLing Xu

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine

Xulq67@aliyun.com+86 15901903361

Outcome results

None listed

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