A Study of ASP8273 versus Erlotinib or Gefitinib as First-Line Treatment for Patients with Stage IIIB/IV Non-Small Cell Lung Cancer

Overview

  • Study type

    Interventional
  • Study phase

    III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Scottsdale/Phoenix, Arizona: 16-001142
    • Rochester, Minnesota: 16-001142
    NCT ID: NCT02588261
    Sponsor Protocol Number: 8273-CL-0302

About this study

The purpose of the study is to evaluate progression free survival, using independent radiologic review, of ASP8273 compared to erlotinib or gefitinib in patients with locally advanced, metastatic or unresectable stage IIIB/IV adenocarcinoma non-small cell lung cancer that has epidermal growth factor receptor (EGFR) activating mutations.

This study will also assess overall survival, overall response rate, progression free survival assessed by the investigator, disease control rate, duration of response, safety of ASP8273, quality of life, and patient-reported outcome parameters.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  • No participation in another interventional study while on treatment
  • Female subject must
    • Be of nonchildbearing potential
      • Postmenopausal (defined as at least 1 year without any menses) prior to screening
      • Documented surgically sterile
    • If of childbearing potential
      • Agree to not try to become pregnant during the study and for 28 days after the final study drug administration
      • Have a negative serum pregnancy test at screening
    • If heterosexually active
      • Agree to consistently use 2 forms of highly effective birth control
        • At least 1 method must be a highly effective method and one must be a barrier method
        • Used throughout the study period starting at screening and for 28 days after the final study drug administration
    • Must not be breastfeeding at screening or during the study period, and for 28 days after the final study drug administration
    • Must not donate ova starting at screening and throughout the study period, and for 28 days after the final study drug administration
  • Males and their female partners who are of childbearing potential
    • Must be using highly effective contraception consisting of 2 forms of birth control (1 of which must be a barrier method) starting at screening and continue throughout the study period and for 90 days after the final study drug administration
    • Must not donate sperm starting at screening and throughout the study period and for 90 days after the final study drug administration
  • Has Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Has histologically confirmed, locally advanced, metastatic or unresectable stage IIIB/IV adenocarcinoma NSCLC (newly diagnosed or recurrent)
  • Has mixed histology and adenocarcinoma is the predominant histology
  • Has predicted life expectancy ≥ 12 weeks in the opinion of the investigator
  • Must meet all of the following criteria on the laboratory tests that will be analyzed centrally within 7 days prior to the first dose of study drug
    • In case of multiple laboratory data within this period, the most recent data should be used
      • Neutrophil count > 1,000/mm3
      • Platelet count ≥ 7.5 x 104 /mm3
      • Hemoglobin > 8.0 g/dL
      • Serum creatinine ˂ 2.0 x upper limit of normal (ULN) or an estimated glomerular filtration rate (eGFR) of > 50 mL/min as calculated by the Cockcroft Gault Method
      • Total bilirubin ˂ 1.5 x ULN (except for subjects with documented Gilbert's syndrome)
      • AST and ALT ˂ 3.0 x ULN or ≤ 5 x ULN if subject has documented liver metastases
      • Serum sodium level is ≥ 130 mmol/L
  • Has an EGFR activating mutation (exon 19 deletion or exon 21 L858R), with or without T790M mutation by local or central testing of specimen (archival or fresh biopsy) 
    • Having both exon 19 deletion and exon 21 L858R mutations is not eligible
    • A tissue sample from the same block used to determine eligibility by local testing should be available to send to the central lab for confirmatory testing
    • If randomized based on local results indicating presence of EGFR mutation, may remain on study if central results are discordant
  • Must have at least 1 measureable lesion based on RECIST V1.1
    • Previously irradiated lesions will not be considered as measurable lesions

Exclusion Criteria

  • Has received intervening anticancer treatment or previous treatment with chemotherapy for metastatic disease other than palliative local radiation to painful bone metastases completed at least 1 week prior to the first dose of study drug
    • The administration of neoadjuvant or adjuvant chemotherapy is allowed as long as it has finalized ≥ 6 months before the first dose of study drug
  • Has received a prior treatment with a therapeutic agent targeting EGFR (e.g., afatinib, dacomitinib, ASP8273, etc)
  • Has received investigational therapy within 28 days or 5 half-lives prior to the first dose of study drug 
  • Has received radiotherapy within 1 week prior to the first dose of study drug
  • If radiotherapy was received > 1 week prior to study treatment, the irradiated lesion cannot be the only lesion used for evaluating response
  • Has symptomatic central nervous system (CNS) metastasis
    • Previously treated brain or CNS metastases is eligible provided the subject
      • Has recovered from any acute effects of radiotherapy
      • Does not have brain metastasis related symptoms
      • Is not requiring systemic steroids for at least 2 weeks prior to study drug administration
      • Any whole brain radiation therapy was completed at least 4 weeks prior to study drug administration
      • Any stereotactic radiosurgery  was completed at least 2 weeks prior to study drug administration
        • Steroid inhaler use or ointment treatment for other concomitant medical disease is permitted
  • Has received blood transfusions or hematopoietic factor therapy within 14 days prior to the first dose of study drug
  • Has had a major surgical procedure (other than a biopsy) within 14 days prior to the first dose of study drug, or one is planned during the course of the study
  • Has a known history of a positive test for human immunodeficiency virus (HIV) infection
  • Has known history of serious hypersensitivity reaction to a known ingredient of ASP8273, erlotinib or gefitinib
  • Has evidence of an active infection requiring systemic therapy within 14 days prior to the planned first dose of study drug
  • Has severe or uncontrolled systemic diseases including uncontrolled hypertension (blood pressure > 150/100 mmHg) or active bleeding diatheses
  • Has history of drug-induced interstitial lung disease (ILD) or any evidence of active ILD
  • Has ongoing cardiac arrhythmia that is grade ≥ 2 or uncontrolled atrial fibrillation of any grade
  • Currently has class 3 or 4 New York Heart Association congestive heart failure
  • Has history of severe/unstable angina, myocardial infarction or cerebrovascular accident within 6 months prior to the planned first dose of study drug
  • Has history of gastrointestinal ulcer or gastrointestinal bleeding within 3 months prior to the planned first dose of study drug
  • Has concurrent corneal disorder or any ophthalmologic condition which, in the investigator's opinion, makes the subject unsuitable for study participation (i.e., advanced cataracts, glaucoma)
  • Has difficulty taking oral medication or any digestive tract dysfunction or inflammatory bowel disease that would interfere with the intestinal absorption of drug 
  • Has another past or active malignancy which requires treatment
    • Prior carcinoma in situ or non-melanoma skin cancer after curative resection are permitted
  • Has any condition which, in the investigator's opinion, makes the subject unsuitable for study participation
  • Has received potent CYP 3A4 inhibitors within 7 days prior to first dose of study drug or proton pump inhibitors such as omeprazole within 14 days prior to first dose of study drug

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Aaron Mansfield, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Aaron Mansfield, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

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CLS-20228038

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