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Intercalated Combination of Chemotherapy and Tyrosine Kinase Inhibitors as First-line Treatment for Patients With Non-Small-Cell Lung Cancer (TCL-1)

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ClinicalTrials.gov Identifier: NCT02031601
Recruitment Status : Unknown
Verified November 2015 by Qian Qi, Qilu Hospital of Shandong University.
Recruitment status was:  Recruiting
First Posted : January 9, 2014
Last Update Posted : March 29, 2016
Sponsor:
Information provided by (Responsible Party):
Qian Qi, Qilu Hospital of Shandong University

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.


Condition or disease Intervention/treatment Phase
Non-Small-Cell Lung Cancer Drug: Erlotinib Drug: Gefitinib Drug: Icotinib Drug: Docetaxel Drug: Pemetrexed Drug: Platinum (cisplatin or carboplatin) Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: 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)

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
Other Name: Tarceva

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
Other Name: Iressa

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
Other Name: Conmana

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

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

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

TKI alone therapy

Interventions:

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

Drug: Erlotinib
150mg po once a day daily until disease progression
Other Name: Tarceva

Drug: Gefitinib
250mg po once a day daily until disease progression
Other Name: Iressa

Drug: Icotinib
125mg po three times a day daily until disease progression
Other Name: Conmana




Primary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: 8 weeks ]
    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.


Secondary Outcome Measures :
  1. Objective response rate [ Time Frame: 8 weeks ]
  2. Duration of response [ Time Frame: 8 weeks ]
  3. Time to progression [ Time Frame: 8 weeks ]
  4. Overall survival (OS) [ Time Frame: 8 weeks ]
  5. Clinical benefit rate [ Time Frame: 8 weeks ]
  6. Adverse Events (AEs), Serious Adverse Events (SAEs), laboratory data [ Time Frame: 4 weeks ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02031601


Contacts
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Contact: Qian Qi, MS 008615165197262 610160008@qq.com

Locations
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China, Shandong
Yu Li Recruiting
Jinan, Shandong, China, 250012
Contact: Yu Li         
Sponsors and Collaborators
Qilu Hospital of Shandong University
Investigators
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Study Director: Yu Li, Professor Director

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Responsible Party: Qian Qi, assistant director, Qilu Hospital of Shandong University
ClinicalTrials.gov Identifier: NCT02031601     History of Changes
Other Study ID Numbers: QLHX-0531
First Posted: January 9, 2014    Key Record Dates
Last Update Posted: March 29, 2016
Last Verified: November 2015
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Cisplatin
Carboplatin
Docetaxel
Erlotinib Hydrochloride
Pemetrexed
Gefitinib
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors