Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Amino Acids

Vitamins

Carboplatin

Pemetrexed

Docetaxel

Cisplatin

Tyrosine Kinase Inhibitors

Erlotinib Hydrochloride

Gefitinib

Tubulin Modulators

Antimitotic Agents

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Protein Kinase Inhibitors

Tyrosine

Folinic Acid

Folate

Vitamin B9

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)

Interventions:

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

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

Erlotinib

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

Icotinib

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

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

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

Platinum (cisplatin or carboplatin)

150mg po once a day daily until disease progression

250mg po once a day daily until disease progression

125mg po three times a day daily until disease progression

Qian Qi, MS

Yu Li

Yu Li, Professor

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.

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

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

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Intercalated Combination of Chemotherapy and Tyrosine Kinase Inhibitors as First-line Treatment for Patients With Non-Small-Cell Lung Cancer	NCT02031601	Non-Small-Cell ...	Erlotinib Gefitinib Icotinib Docetaxel Pemetrexed Platinum (cispl... Erlotinib Gefitinib Icotinib	18 Years - 80 Years	Qilu Hospital of Shandong University
Intercalated Combination of Chemotherapy and Tyrosine Kinase Inhibitors as First-line Treatment for Patients With Non-Small-Cell Lung Cancer	NCT02031601	Non-Small-Cell ...	Erlotinib Gefitinib Icotinib Docetaxel Pemetrexed Platinum (cispl... Erlotinib Gefitinib Icotinib	18 Years - 80 Years	Qilu Hospital of Shandong University

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