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Study of Chinese Medicine Plus EGFR-TKI Versus EGFR-TKI in Advanced Pulmonary Adenocarcinoma: a Randomized Double-blind Controlled Clinical Trial

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Trial Information

Study of Chinese Medicine Plus EGFR-TKI Versus EGFR-TKI in Advanced Pulmonary Adenocarcinoma: a Randomized Double-blind Controlled Clinical Trial

At present, the third generation of platinum-based regimens (NCCN clinical practice
guidelines recommended the use of vinorelbine or gemcitabine, or Taxol, etc.) is the
first-line treatment for advanced lung cancer patients. Its effective rate is 20-30%, the
median survival time is 7-9 months, 1-year and 2-year survival rate is 31-36% and 10-13%
respectively. The efficacy has reached the platform and it is difficult to have more
breakthroughs. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) such
as Iressa and Erlotinib have proved effective in first or second line therapy for advanced
non-small cell lung cancer(NSCLC).First-SIGNAL and IPASS research have laid first-line
status for gefitinib in treatment of NSCLC and the progression-free survival time was
maintained at 9-10 months. EGFR-TKIs treatment is simple, well tolerated, drug side effects,
etc. There are also a rash, diarrhea and other adverse reactions, affecting the quality of
life of patients with serious or even give patients a great deal of pain.Literature and our
preliminary studies have shown that traditional Chinese medicine (TCM) can prolong survival
time and improve quality of life QOL, but high-level evidences are needed.

The investigators perform a randomized, double-blind controlled, prospective study in
Advanced Pulmonary Adenocarcinoma patients with stage Ⅲa~Ⅳ. Patients are randomized over
observational group (TCM granules plus first-line targeted therapy and TCM granules plus
second-line targeted therapy ), and control group (TCM placebo plus first-line targeted
therapy and TCM placebo plus second-line targeted therapy). The investigators will observe 6
months and after that regular follow-up will be arranged. The primary efficacy assessments
are: PFS (progression-free survival); Secondary efficacy assessments are: (1) OS(overall
survival); (2) Objective response rate; (3) TTP(Time-to-Progression); (4) QOL (Functional
Assessment of Cancertherapy-lung, FACT-L4.0 scales;Lung Cancer Symptom Scale,LCSS); (5)other
efficacy assessments are: 1) TCM symptoms changes; 2) Toxicity, side effects and security of
the treatments will be assessed at the same time. The investigators expect that integrated
TCM combined with targeted therapy has a better efficacy on prolonging progression-free
survival time, overall survival, improving QOL of patients than that of targeted therapy.
Therefore our study can provide evidences for optimizing and promoting integrated TCM
combined with Western Medicine treatment.

Inclusion Criteria:

1. Pathologically or cytologically confirmed of stage IIIa-IV NSCLC with adenocarcinoma

2. Patient with mutated EGFR will subject to first line target thearapy;patients
received at least one cycle platinum-containing chemotherapy regimens with disease
progression/recurrence, or intolerant/refuse to proceed with chemotherapy will
explore second line target therapy;

3. Physical status score (ECOG PS) ≤ 2 scores;

4. Age ≥18 years old;

5. Estimated life expectancy of at least 12 weeks;

6. Participants have no major organ dysfunction: hemoglobin ≥9 g/dL, absolute neutrophil
count (ANC) ≥1.5*109/L, platelets ≥100 *109/L,bilirubin ≤1.5ULN, alkaline phosphatase
(AP), aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 upper limited
number(ULN) (AP, AST, ALT ≤5ULN is acceptable if liver has tumor
involvement).INR≤1.5, APTT in the normal range( 1.2DLN-1.2ULN),creatinine ≤1.5ULN;

7. Informed consent from the patient.

Exclusion Criteria:

1. Patient with other malignant tumor except NSCLC 5 years previous to study entry.

2. Wild type EGFR; already receiving targeted treatment or other anticancer treatment
such as palliative radiotherapy if it was not finished over 4 weeks or operation was
not over 4 weeks before the first drug administration ;

3. Estimated life expectancy less than 12 weeks;

4. Brain metastasis (controlled brain metastasis and steroid free need is excluded).

5. History of cardiovascular disease: Congestive Heart Failure > grade II in NYHA.
Unstable angina patients (have angina symptoms in rest) or a new occurrence of angina
(began in the last 3 months) or myocardial infarction happens in the last 6 months;

6. Pregnant or child breast feeding women;

7. Mental or cognitive disorders.

Type of Study:


Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Progression-free survival(PFS)

Outcome Time Frame:

2 months

Safety Issue:


Principal Investigator

Ling Xu, MD & PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Longhua Hospital Affiliated to Shanghai University of TCM


China: Science and Technology Commission of Shanghai Municipality

Study ID:




Start Date:

November 2011

Completion Date:

September 2014

Related Keywords:

  • Cancer
  • lung cancer
  • traditional Chinese medicine
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous