Intercalated Combination of Chemotherapy and Tyrosine Kinase Inhibitors as First-line Treatment for Patients With Non-Small-Cell Lung Cancer

Non-Small-Cell Lung Cancer Clinical Trial

— TCL-1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02031601
• Other study ID #: QLHX-0531
• Status: Recruiting
• Phase: Phase 4
• First received: January 2, 2014
• Last updated: March 28, 2016
• Start date: January 2014
• Est. completion date: December 2017

Study information

• Verified date: November 2015
• Source: Qilu Hospital
• Contact: Qian Qi, MS
• Phone: 008615165197262
• Email: 610160008[@]qq.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Adult patients, >=18 years of age;

• Advanced (stage IIIB/IV) non-small-cell lung cancer;

• Although stage?-?A, 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small-Cell Lung Cancer

Intervention

Drug:
• Erlotinib
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
• Gefitinib
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
• Icotinib
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
• Docetaxel
75 mg/m2 ivgtt on days 1 of each 3 week cycle for 4 cycles
• Pemetrexed
500 mg/m2 ivgtt on days 1 of each 3 week cycle for 4 cycles
• Platinum (cisplatin or carboplatin)
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
• Erlotinib
150mg po once a day daily until disease progression
• Gefitinib
250mg po once a day daily until disease progression
• Icotinib
125mg po three times a day daily until disease progression

Locations

Country	Name	City	State
China	Yu Li	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Objective response rate		8 weeks	No
Secondary	Duration of response		8 weeks	No
Secondary	Time to progression		8 weeks	No
Secondary	Overall survival (OS)		8 weeks	No
Secondary	Clinical benefit rate		8 weeks	No
Secondary	Adverse Events (AEs), Serious Adverse Events (SAEs), laboratory data		4 weeks	Yes