Clinical trial NCT02495233 (phase 1/phase 2, status: terminated)
Conditions: non-small-cell lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: gilteritinib, erlotinib
SMILES: CCC1=C(NC2CCOCC2)N=C(NC2=CC=C(N3CCC(CC3)N3CCN(C)CC3)C(OC)=C2)C(=N1)C(N)=O, COCCOC1=CC2=C(C=C1OCCOC)C(NC1=CC(=CC=C1)C#C)=NC=N2
Reason stopped: 
    study terminated due to adverse events related to the combination therapy
  
Eligibility criteria:

        IInclusion Criteria:

          -  Participant had histologically or cytologically confirmed metastatic or locally
             advanced, unresectable non-small-cell lung cancer (NSCLC).

          -  Participant had a documented exon 19 deletion or exon 21 L858R EGFR activating
             mutation.

          -  Participant had received prior treatment with any EGFR tyrosine kinase inhibitor

          -  Participant had Eastern Cooperative Oncology Group (ECOG) performance status of less
             than or equal to 2 at screening.

          -  Participant had adequate organ function.

          -  Female participant must either:

               -  Be of nonchildbearing potential:

               -  Or, if of childbearing potential,

                    1. Agree not to try to become pregnant during the study and for 45 days after
                       the final study drug administration

                    2. And had a negative serum pregnancy test at screening

                    3. And, if heterosexually active, agreed to consistently use 2 forms of highly
                       effective birth control

          -  Male participant and their female spouse/partners who were of childbearing potential
             must be using highly effective contraception consisting of 2 forms of birth control

          -  Phase 1b Participants only:

               -  Participant was not expected to show a therapeutic response to existing available
                  treatment.

               -  Intervening anticancer treatment subsequent to the EGFR TKI was allowed (but not
                  required).

          -  Additional inclusion criteria for phase 2 Participants only:

               -  Participant had a NSCLC tissue sample obtained after participant developed
                  resistance to EGFR TKI therapy that was available for central testing.

               -  Participant's baseline tumor specimen (obtained after participant developed
                  resistance to EGFR TKI therapy) is T790M negative.

               -  Participant received an EGFR TKI for at least 6 months and progressed on this
                  therapy within the past 28 days.

               -  Participant had not had any intervening anticancer treatment subsequent to the
                  EGFR TKI with the exception of radiotherapy which was allowed if it occurred at
                  least 14 days prior to the first dose of study drug.

               -  Participant had at least 1 measureable lesion (not including any lesion that was
                  irradiated) based on Response Evaluation Criteria in Solid Tumors (RECIST)
                  version 1.1.

        Exclusion Criteria:

          -  Participant had an ongoing toxicity greater than or equal to grade 3 (NCI CTCAE
             version 4.03) attributable to prior NSCLC treatment at the time of screening.

          -  Participant received any agent with antitumor activity (other than an EGFR inhibitor,
             including a T790M inhibitor) including chemotherapy, radiotherapy, immunotherapy,
             within 14 days prior to the first dose of study drug (palliative radiotherapy is
             allowed).

          -  Participant received ASP2215 previously.

          -  Participant received blood transfusions or hematopoietic growth factor therapy within
             14 days prior to the first dose of study drug.

          -  Participant had a major surgical procedure (other than study-related biopsy) within 14
             days prior to the first dose of study drug, or a major surgical procedure was planned
             to occur during the study.

          -  Participant had active hepatitis B or C or other active hepatic disorder.

          -  Participant t was known to have human immunodeficiency virus (HIV) infection.

          -  Participant had symptomatic central nervous system (CNS) metastasis. Participants with
             asymptomatic, untreated CNS metastases were allowed. Participants with previously
             treated and currently asymptomatic CNS metastases were eligible provided they met the
             following:

               -  Any whole brain radiotherapy (WBRT) was completed at least 2 weeks prior to the
                  first dose of study drug.

               -  Any stereotactic radiosurgery (SRS) was completed at least 1 week prior to the
                  first dose of study drug.

               -  Participant did not require steroids or did not require escalating doses of
                  steroids for at least 2 weeks prior to the first dose of study drug.

          -  Participant had evidence of active infection requiring systemic therapy within 14 days
             prior to the first dose of study drug.

          -  Participant had uncontrolled hypertension.

          -  Participant had severe or uncontrolled systemic diseases or active bleeding diatheses.

          -  Participant had history of drug-induced interstitial lung disease or any evidence of
             active interstitial lung disease.

          -  Participant had ongoing cardiac arrhythmia (including atrial fibrillation) that was
             grade ≥ 2.

          -  Participant currently had Class 3 or 4 New York Heart Association congestive heart
             failure.

          -  Participant had history of severe/unstable angina, myocardial infarction or
             cerebrovascular accident within 6 months prior to the first dose of study drug.

          -  Participant had history of gastrointestinal ulcer within 28 days prior to the first
             dose of study drug.

          -  Participant had a history of gastrointestinal bleeding within 90 days prior to the
             first dose of study drug.

          -  Participant had concurrent corneal disorder or any ophthalmologic condition which
             makes the participant unsuitable for study participation .

          -  Participant had any condition which made the participant unsuitable for study
             participation.

          -  Participant had hypokalemia or hypomagnesemia at screening.

          -  Participant had QTcF interval > 450 ms on 12-lead ECG at screening.

          -  Participant was known to have long QT syndrome.

          -  Participant was taking medication known to prolong the QT interval.