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Erlotinib Combined With Chemotherapy in TKI Resistant Non-Small Cell Lung Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02098954
Recruitment Status : Recruiting
First Posted : March 28, 2014
Last Update Posted : March 26, 2020
Sponsor:
Information provided by (Responsible Party):
Yongchang Zhang, Hunan Province Tumor Hospital

Study Description
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Brief Summary:
Numerous evidences verified that erlotinib could dramatically improve the PFS and OS of non-small cell lung cancers who harbor EGFR sensitive mutations, however, primary or secondary resistance will be developed after TKI treatment, doctors do plenty of researches to overcome TKI resistance. FAST ACT-2 study present that, first line erlotinib combined with chemotherapy could improved mOS to more than 30 months in NSCLCs who harbor EGFR sensitive mutations, several study shows that sensitive mutations still exist after TKI resistance, because of the next generation TKIs(such as BIBW2992) are not avaliable at present, agents for met amplification(such as Crizotinib) are so expensive that many Chinese patients could not support. Thus, the investigators hypothesis that, after first line TKI treatment, the patients who developed TKI resistance could still benefit from second line TKI combined with chemotherapy.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small Cell Lung EGFR Gene Mutation Drug: Gemcitabine platinum combined with erlotinib Phase 2

Detailed Description:

The investigators will enroll patients diagnosed with advanced non-squamous,non-small cell lung cancer, patients with EGFR TKI sensitive mutations and developed TKI resistance in first line treatment. After enrollment, the investigators will do biopsy again before second line treatment to find out the potential mechanism of TKI resistance, do EGFR mutation test for both sensitive and resistant mutation in exon 18, 19, 20 and 21; do KRAS, BRAF and PI3K mutation test, do FISH for MET and HER-2, the investigators do all these test to evaluated both primary and secondary resistance, the investigators do all these tests to get an overview for EGFR mutation status of each patient who develop TKI resistance. For second line treatment, patients will received a 28 days gemcitabine platinum combined with erlotinib scheme, after 4 cycle of combined chemotherapy, patients will receive erlotinib for further treatment until progression disease. For the patients who have stable brain metastases, combined chemotherapy should begin after local treatment, such as whole brain radiotherapy or sterotactic radiosurgery.

the main endpoint of this study is mean PFS, second endpoints of this study consist of mean OS, 8 week ORR.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Second Line Erlitinib Combination With Gemcitabine Cisplatinum in Non-small Cell Lung Cancer Patients Who Harbored EGFR Sensitive Mutation Developed Resistance After First Line TKI Treatment
Actual Study Start Date : July 1, 2014
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: experimental
patients will received a 28 days gemcitabine platinum combined with erlotinib scheme(gemcitabine for day 1 and day 8, 1250mg/m2. Platinum for day 1, 75mg/m2. Erlotinib for 150mg/day, day 9-21 every cycle, after 4 cycles, erlotinib should be used daily), after 4 cycle of combined chemotherapy, patients will receive erlotinib for further treatment until progression disease.
 Drug: Gemcitabine platinum combined with erlotinib
patients will received a 28 days gemcitabine platinum combined with erlotinib scheme, after 4 cycles combined chemotherapy, patients will receive erlotinib for maintain treatment until progression disease.Gemcitabine for day 1 and day 8, 1250mg/m2. Platinum for day 1, 75mg/m2. Erlotinib for day 9-21 during combined chemotherapy, 150mg/day, then erlotinib should be used daily until patients develop progression disease.
Other Names:
  • Gemzar
  • Tarceva


Outcome Measures
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Primary Outcome Measures :
  1. mean progression free survival(mPFS) [ Time Frame: after patients receive treatment, mPFS should be measured before the third cycle of chemotherapy, after the fourth cycle, mPFS should be measured every 3 months up to two years ]
    mean progression free survival(mPFS) will be recorded in enroll patients who received second line gemcitabine platinum combined with erlotinib. mPFS should be measured before second line treatment, before the third combined chemotherapy, after the fourth combined chemotherapy, every 3 months during erlotinib treatment, mPFS should be measured up to two years or every time progression disease occurs within two years.


Secondary Outcome Measures :
  1. mean overall survival(mOS) [ Time Frame: every 3 months up to 3 years, or until all the survival data is obtained ]
    mOS should be measured since enrollment, every 3 months we will contact patients to find out detail survival data of each patient until 3 years, or within 3 years if all survival data is obtained.

  2. 8 week overall response rate(8 week ORR) [ Time Frame: 8 week ORR should be measured after enrollment, the exact time point should be the ninth week after combined chemotherapy ]
    8 week ORR should be measured after enrollment, after combined chemotherapy for 8 weeks, the exact time point should be the ninth week during combined chemotherapy. CR, PR, SD shoud be measured according to RESICT 1.1


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • advanced non-small cell lung cancer, stage IIIB/IV
  • non-squamous
  • EGFR sensitive mutations, such as exon 19 del, or exon 21 L858R
  • received first line TKIs treatment and developed TKI resistance
  • ECOG 0-2

Exclusion Criteria:

  • squamous non-small cell lung cancer
  • patients have unstable brain metastasis, predict survival less than 8 weeks
  • spinal-cord compression without evidence of stabilisation or treatment
  • women who were pregnant or lactating; women with a positive or no available pregnancy test result at baseline
  • patients have any unstable illness that could not receive further treatment
Contacts and Locations
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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): NCT02098954


Contacts
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Contact: Nong Yang, MD +86 731 89762323 yangnong0217@163.com
Contact: Ming Zhou, MD +86 731 89762320 zhouming243@163.com

Locations
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China, Hunan
Hunan Province Tumor Hospital Recruiting
Changsha, Hunan, China
Contact: Nong Yang, MD    +86 731 89762323    yangnong0217@163.com   
Contact: Ming Zhou, MD    +86 731 89762321    zhouming243@gmail.com   
Principal Investigator: Nong Yang, MD         
Sponsors and Collaborators
Hunan Province Tumor Hospital
Investigators
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Study Chair: Nong Yang, MD Hunan Province Tumor Hospital
More Information
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Publications of Results:

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Responsible Party: Yongchang Zhang, HunanPTH, Hunan Province Tumor Hospital
ClinicalTrials.gov Identifier: NCT02098954    
Other Study ID Numbers: TKIRR001
First Posted: March 28, 2014    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: March 2020
Keywords provided by Yongchang Zhang, Hunan Province Tumor Hospital:
TKI
resistance
erlotinib
combined chemotherapy
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Erlotinib Hydrochloride
 Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors