Clinical trial NCT02031601: Intercalated Combination of Chemotherapy and Tyrosine Kinase Inhibitors as First-line Treatment for Patients With Non-Small-Cell Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Non-Small-Cell Lung Cancer
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2014-01-09
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

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.

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: 8 weeks
Secondary outcomes:
measure: Objective response rate
timeFrame: 8 weeks
measure: Duration of response
timeFrame: 8 weeks
measure: Time to progression
timeFrame: 8 weeks
measure: Overall survival (OS)
timeFrame: 8 weeks
measure: Clinical benefit rate
timeFrame: 8 weeks
measure: Adverse Events (AEs), Serious Adverse Events (SAEs), laboratory data
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Jinan
country: China
facility: Yu Li
state: Shandong
Study officials:
affiliation: Director
name: Yu Li, Professor
role: STUDY_DIRECTOR
References:
citation: 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.