Clinical Trials /

Afatinib in Lung Cancer With EGFR Mutation From Circulating Tumor DNA

NCT02629523

Description:

Treatment efficacy of afatinib will be assessed in patients with lung cancer harboring EGFR mutations which were detected from circulating tumor DNA.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Afatinib in Lung Cancer With EGFR Mutation From Circulating Tumor DNA
  • Official Title: A Phase II, Open-Label, Multicentre Study to Assess the Anti-tumour Activity of Afatinib in Patients With Activating Epidermal Growth Factor Receptor Mutation in Circulating Tumor DNA

Clinical Trial IDs

  • ORG STUDY ID: 1200.271
  • NCT ID: NCT02629523

Conditions

  • Lung Neoplasms
  • EGFR Gene Mutation

Interventions

DrugSynonymsArms
AfatinibGiotrifAfatinib

Purpose

Treatment efficacy of afatinib will be assessed in patients with lung cancer harboring EGFR mutations which were detected from circulating tumor DNA.

Detailed Description

      Obtaining Tumor tissue or cytology samples are not always available in some patients with
      lung cancer. Recently, studies showed that circulating tumor DNA can be used as a suitable
      substitute for mutation analysis. The sensitivity of EGFR mutation tests using circulating
      tumor DNA was reported in the range of 65.7% (10) to 75% (11), with high specificity and
      positive predictive value. In this trial, treatment efficacy of afatinib will be assessed in
      patients with NSCLC harboring EGFR mutations which were detected from circulating tumor DNA.
    

Trial Arms

NameTypeDescriptionInterventions
AfatinibExperimentalTreatment efficacy of afatinib will be assessed in patients with lung cancer harboring EGFR mutations which were detected from circulating tumor DNA.
  • Afatinib

Eligibility Criteria

        Inclusion Criteria:

          1. Stage IIIB or IV lung cancer diagnosed radiologically with or without pathologic
             diagnosis

          2. Age> 18 year-old

          3. ECOG performance status 0~2.

          4. Activating EGFR mutation (G719X, exon 19 deletion, L858R, L861Q) detected from
             circulating DNA

          5. Any one of the following criteria should be met

               -  Unavailable or failed pathologic/cytologic diagnosis

               -  Wild type or failed EGFR testing based on tumor tissue

               -  No more tumor sample available for EGFR test

          6. Measurable lesion by RECIST v1.1

          7. Females should be using adequate contraceptive measures, should not be breast feeding
             and must have a negative pregnancy test prior to start of dosing or evidence of
             non-child bearing potential.

          8. Male patients should be willing to use barrier contraception.

          9. Provision of signed and dated, written informed consent prior to any study specific
             procedures, sampling and analyses

         10. Adequate organ function, defined as all of the following:

               -  Absolute neutrophil count (ANC) >=1500/mm3

               -  Platelet count >= 75,000 /mm3

               -  Serum creatinine < 1.4 mg/dL

               -  AST or ALT < three times the upper limit of normal

        Exclusion Criteria:

          1. Prior exposure to EGFR-TKI. Prior chemotherapy will be permitted.

          2. Previous or concomitant malignancies at other sites, except effectively treated
             non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ
             or effectively treated malignancy that has been in remission for more than 3 years and
             is considered to be cured.

          3. Severe or unstable medical conditions such as history or presence of clinically
             relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive
             heart failure NYHA classification of ≥ 3, unstable angina or poorly controlled
             arrhythmia as determined by the investigator. Myocardial infarction within 6 months
             prior to randomisation.

          4. Known pre-existing interstitial lung disease

          5. Any history or presence of poorly controlled gastrointestinal disorders that could
             affect the absorption of the study drug (e.g. Crohn's disease, ulcerative colitis,
             chronic diarrhoea, malabsorption)

          6. Active hepatitis B infection (defined as presence of HepB sAg and Hep B DNA), active
             hepatitis C infection (defined as presence of Hep C RNA) and/or known HIV carrier.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:19 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Efficacy evaluation RECIST v1.1
Time Frame:2 months
Safety Issue:
Description:Efficacy evaluation RECIST v1.1

Secondary Outcome Measures

Measure:Progression Free Survival
Time Frame:2 years
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Chonnam National University Hospital

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