Clinical Study of Chinese Medicine Plus Targeted Therapy Maintenance in Advanced Pulmonary Adenocarcinoma

NCT02889692 | Completed Phase 3 DMC

• 1 other identifier: LH127
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigators performed a randomized, double blind controlled, prospective study method on observation of Traditional Chinese Medicine (TCM) combined with targeted therapy maintenance to prolong the efficacy of long-term survival of advanced pulmonary adenocarcinoma patients. The investigators plan to involve 200 cases for observation in 3 years (100 cases for targeted therapy maintenance, 100 cases for targeted therapy maintenance plus TCM,), expecting that integrated TCM combined with targeted maintenance therapy has a better efficacy on prolonging progression-free survival time, overall survival, improving quality of life(QOL) of patients than that of targeted maintenance therapy.

Conditions

Cancer

Keywords

lung cancer; traditional Chinese medicine; maintenance therapy; targeted therapy

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  It referred to the interval time from the first date of randomization to that of death for any reason, the end of the study, or loss of follow-up.

  2 months

Secondary Outcomes (3)

• Progression-free survival (PFS)

  2 months

• Objective response rate (ORR)

  2 months

• Quality of life (QOL)

  2 months

Other Outcomes (2)

• TCM symptoms changes

  2 months

• Safety assessment evaluated according to Common Toxicity Criteria

  2 months

Study Arms (2)

TCM granules plus EGFR-TKIs

EXPERIMENTAL

TCM granules: oral granules, "YiQiFang" or "YangYinFang" or "YiQiYangYinFang", four packages, twice a day, until progression or unacceptable toxicity; EGFR-TKIs: oral tablet, Gefitinib® 250mg daily or Erlotinib® 150mg daily or Icotinib® 125 mg three times a day，until progression or unacceptable toxicity.

Drug: YiQiFang; Drug: YangYinFang; Drug: YiQiYangYinFang; Drug: Erlotinib®; Drug: Gefitinib®; Drug: Icotinib®

Placebo granules plus EGFR-TKIs

PLACEBO COMPARATOR

Placebo granules: oral granules, which the taste and smell are similar to experimental TCM granules and has no therapeutic effect, four packages, twice a day, until progression or unacceptable toxicity; EGFR-TKIs: oral tablet, Gefitinib® 250mg daily or Erlotinib® 150mg daily or Icotinib® 125 mg three times a day until progression or unacceptable toxicity.

Drug: placebo granules; Drug: Erlotinib®; Drug: Gefitinib®; Drug: Icotinib®

Interventions

YiQiFang DRUG

Prescriptions formulated into TCM granules origin from Professor Liu Jia-xiang in Longhua hospital. Package of granules is made into three types with functions such as benefiting Qi, benefiting Yin and detoxication recipe. YiQiFang: Patients with Qi deficiency syndrome are administered two packages of each benefiting Qi and detoxication recipe, four packages, twice a day, until progression or unacceptable.

TCM granules plus EGFR-TKIs

YangYinFang DRUG

Prescriptions formulated into TCM granules origin from Professor Liu Jia-xiang in Longhua hospital. Package of granules is made into three types with functions such as benefiting Qi, benefiting Yin and detoxication recipe. YangYinFang: Patients with Yin deficiency syndrome are administered two packages of each benefiting Yin and detoxication recipe, four packages, twice a day, until progression or unacceptable.

TCM granules plus EGFR-TKIs

YiQiYangYinFang DRUG

Prescriptions formulated into TCM granules origin from Professor Liu Jia-xiang in Longhua hospital. Package of granules is made into three types with functions such as benefiting Qi, benefiting Yin and detoxication recipe. YiQiYangYinFang: Patients with Qi and Yin deficiency syndrome are administered one package of each benefiting Qi and benefiting Yin and two packages of detoxication recipe, four packages, twice a day, until progression or unacceptable.

TCM granules plus EGFR-TKIs

placebo granules DRUG

Oral granules, which the taste and smell are similar to experimental TCM granules, has no therapeutic effect, four packages, twice a day, until progression or unacceptable.

Placebo granules plus EGFR-TKIs

Erlotinib® DRUG

"Erlotinib®","tarceva", 150 mg oral once a day until progression or unacceptable toxicity develops.

Also known as: tarceva

Placebo granules plus EGFR-TKIs; TCM granules plus EGFR-TKIs

Gefitinib® DRUG

"Gefitinib®","Iressa", 250 mg oral once a day until progression or unacceptable toxicity develops.

Also known as: Iressa

Placebo granules plus EGFR-TKIs; TCM granules plus EGFR-TKIs

Icotinib® DRUG

"Icotinib®","Conmana" 125 mg oral three times a day until progression or unacceptable toxicity develops.

Also known as: Conmana

Placebo granules plus EGFR-TKIs; TCM granules plus EGFR-TKIs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically or cytologically confirmed of stage IIIa-IV pulmonary adenocarcinoma;
• The efficacy evaluation of the first-line therapy is progression-free including complete response(CR), partial response(PR) and stable disease(SD);
• Age ≥18 years old;
• Physical status score (ECOG PS) ≤ 2 scores;
• Estimated life expectancy of at least 12 weeks;
• 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;
• Planning for targeted maintenance.
• Informed consent from the patient.

You may not qualify if:

• The efficacy evaluation of the first-line therapy is progressive disease(PD);
• Patient with other malignant tumor except NSCLC 5 years previous to study entry;
• Patient has already received chemotherapy or other anticancer treatment;
• Estimated life expectancy less than 12 weeks;
• Brain metastasis (controlled brain metastasis and steroid free need is excluded);
• 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;
• Pregnant or child breast feeding women;
• Mental or cognitive disorders;

Sponsors & Collaborators

• Shanghai University of Traditional Chinese Medicine: lead
• Shanghai Chest Hospital: collaborator
• Shanghai Pulmonary Hospital, Shanghai, China: collaborator

MeSH Terms

Conditions

Neoplasms; Lung Neoplasms

Interventions

Erlotinib Hydrochloride; Gefitinib; icotinib

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Ling c, MD & PhD

  Longhua Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 25, 2016
• First Posted: September 5, 2016
• Study Start: March 1, 2013
• Primary Completion: December 30, 2016
• Study Completion: June 1, 2017
• Last Updated: April 11, 2019

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will share