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

March 28, 2016 updated by: Qian Qi, Qilu Hospital of Shandong University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Yu Li
        • Contact:
          • Yu Li

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • 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
Drug: Erlotinib
150mg po once a day daily until disease progression
Other Names:
  • Tarceva
Drug: Gefitinib
250mg po once a day daily until disease progression
Other Names:
  • Iressa
Drug: Icotinib
125mg po three times a day daily until disease progression
Other Names:
  • Conmana
Other: TKI alone therapy

Interventions:

Drug: Erlotinib [Tarceva] or Gefitinib [Iressa] or Icotinib [Conmana]
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 Names:
  • 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 Names:
  • 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 Names:
  • Conmana
Drug: Erlotinib
150mg po once a day daily until disease progression
Other Names:
  • Tarceva
Drug: Gefitinib
250mg po once a day daily until disease progression
Other Names:
  • Iressa
Drug: Icotinib
125mg po three times a day daily until disease progression
Other Names:
  • Conmana

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of response
Time Frame: 8 weeks
8 weeks
Overall survival (OS)
Time Frame: 8 weeks
8 weeks
Objective response rate
Time Frame: 8 weeks
8 weeks
Time to progression
Time Frame: 8 weeks
8 weeks
Clinical benefit rate
Time Frame: 8 weeks
8 weeks
Adverse Events (AEs), Serious Adverse Events (SAEs), laboratory data
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Hospital of Shandong University

Investigators

  • Study Director: Yu Li, Professor, Director

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

January 2, 2014

First Submitted That Met QC Criteria

January 8, 2014

First Posted (Estimate)

January 9, 2014

Study Record Updates

Last Update Posted (Estimate)

March 29, 2016

Last Update Submitted That Met QC Criteria

March 28, 2016

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QLHX-0531

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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