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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Non-Small-Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Combination therapy

Interventions:

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)

Group Type EXPERIMENTAL

Erlotinib

Intervention Type DRUG

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

Intervention Type DRUG

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

Intervention Type DRUG

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

Intervention Type DRUG

75 mg/m2 ivgtt on days 1 of each 3 week cycle for 4 cycles

Pemetrexed

Intervention Type DRUG

500 mg/m2 ivgtt on days 1 of each 3 week cycle for 4 cycles

Platinum (cisplatin or carboplatin)

Intervention Type DRUG

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

TKI alone therapy

Interventions:

Drug: Erlotinib \[Tarceva\] or Gefitinib \[Iressa\] or Icotinib \[Conmana\]

Group Type OTHER

Erlotinib

Intervention Type DRUG

150mg po once a day daily until disease progression

Gefitinib

Intervention Type DRUG

250mg po once a day daily until disease progression

Icotinib

Intervention Type DRUG

125mg po three times a day daily until disease progression

Interventions

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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

Intervention Type DRUG

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

Intervention Type DRUG

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

Intervention Type DRUG

Docetaxel

75 mg/m2 ivgtt on days 1 of each 3 week cycle for 4 cycles

Intervention Type DRUG

Pemetrexed

500 mg/m2 ivgtt on days 1 of each 3 week cycle for 4 cycles

Intervention Type DRUG

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

Intervention Type DRUG

Erlotinib

150mg po once a day daily until disease progression

Intervention Type DRUG

Gefitinib

250mg po once a day daily until disease progression

Intervention Type DRUG

Icotinib

125mg po three times a day daily until disease progression

Intervention Type DRUG

Other Intervention Names

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Tarceva Iressa Conmana Tarceva Iressa Conmana

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No