Intercalated Combination of Chemotherapy and Tyrosine Kinase Inhibitors as First-line Treatment for Patients With Non-Small-Cell Lung Cancer
TCL-1
Randomised, Controlled Study Comparing Chemotherapy Plus Intercalated EGFR-Tyrosine Kinase Inhibitors Combination Therapy With EGFR-Tyrosine Kinase Inhibitors Alone Therapy as First-line Treatment for Patients With Non-Small-Cell Lung Cancer
1 other identifier
interventional
250
1 country
1
Brief Summary
Objective: To compare the efficacy and safety of chemotherapy plus intercalated EGFR-tyrosine kinase inhibitors (TKI) combination therapy with TKI alone therapy as first-line treatment for patients with non-small-cell lung cancer (NSCLC). Methods: Patients with untreated, stage IIIB/IV, EGFR mutation-positive NSCLC will be randomly assigned to combination therapy group (receiving four cycles of docetaxel or pemetrexed (on day 1) plus platinum (on day 1) with intercalated TKI (gefitinib, erlotinib or Icotinib, on day 2-15) every 3 weeks) or TKI alone therapy (gefitinib, erlotinib or Icotinib, daily). All patients were continued to receive TKI until progression or unacceptable to toxicity or death. The primary endpoint was progression-free survivial (PFS). Expected results: PFS of combination therapy group will be prolonged to nineteen months while PFS of TKI alone therapy group is ten months. Overall survival (OS) of combination therapy group will be prolonged to 36 months while OS of TKI alone therapy group is 26 months. Hypothesis: Platinum-based chemotherapy plus intercalated TKI combination therapy as first-line treatment will prolong PFS and OS for patients with NSCLC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2014
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 2, 2014
CompletedFirst Posted
Study publicly available on registry
January 9, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedMarch 29, 2016
November 1, 2015
2.9 years
January 2, 2014
March 28, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free survival (PFS)
Progression-free survival (PFS) is defined to be the time from randomization to progression of disease or death, whichever occurs first. Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
8 weeks
Secondary Outcomes (6)
Objective response rate
8 weeks
Duration of response
8 weeks
Time to progression
8 weeks
Overall survival (OS)
8 weeks
Clinical benefit rate
8 weeks
- +1 more secondary outcomes
Study Arms (2)
Combination therapy
EXPERIMENTALInterventions: Drug: Erlotinib \[Tarceva\] or Gefitinib \[Iressa\] or Icotinib \[Conmana\] plus Drug: Docetaxel for patients of lung squamous cell carcinoma; Pemetrexed for patients of lung adenocarcinoma plus Drug: Platinum (cisplatin or carboplatin)
TKI alone therapy
OTHERInterventions: Drug: Erlotinib \[Tarceva\] or Gefitinib \[Iressa\] or Icotinib \[Conmana\]
Interventions
150mg po once a day on days 2-15 of each 3 week cycle for 4 cycles; then continue to receive erlotinib150mg po once a day daily until progression
250mg po once a day on days 2-15 of each 3 week cycle for 4 cycles; then continue to receive gefitinib 250mg po once a day daily until progression
125mg po three time a day on days 2-15 of each 3 week cycle for 4 cycles; then continue to receive icotinib 125mg po three time a day daily until progression
cisplatin -- 75mg/m2 ivgtt on day 1 of each 3 week cycle for 4 cycles or carboplatin -- 5 x AUC ivgtt on day 1 of each 3 week cycle for 4 cycles
Eligibility Criteria
You may qualify if:
- Adult patients, \>=18 years of age;
- Advanced (stage IIIB/IV) non-small-cell lung cancer;
- Although stageⅠ-ⅢA, have contraindications to surgery;
- EGFR mutation-positive (EGFR exon-18, exon-19 or exon-21);
- Measurable disease;
- ECOG Performance Status 0 or 1 or 2.
You may not qualify if:
- Wild-type EGFR;
- Prior exposure to agents directed at the HER axis;
- Prior chemotherapy or systemic anti-tumor therapy after advanced disease;
- Unstable systemic disease;
- Any other malignancy within last 5 years, except cured basal cell cancer of skin or cured cancer in situ of cervix;
- Brain metastasis or spinal cord compression.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yu Li
Jinan, Shandong, 250012, China
Related Publications (1)
Xu L, Qi Q, Zhang Y, Cui J, Liu R, Li Y. Combination of icotinib and chemotherapy as first-line treatment for advanced lung adenocarcinoma in patients with sensitive EGFR mutations: A randomized controlled study. Lung Cancer. 2019 Jul;133:23-31. doi: 10.1016/j.lungcan.2019.05.008. Epub 2019 May 7.
PMID: 31200823DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yu Li, Professor
Director
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant director
Study Record Dates
First Submitted
January 2, 2014
First Posted
January 9, 2014
Study Start
January 1, 2014
Primary Completion
December 1, 2016
Study Completion
December 1, 2017
Last Updated
March 29, 2016
Record last verified: 2015-11