A Study of ASP2215 in Combination With Erlotinib in Subjects With Epidermal Growth Factor Receptor (EGFR) Activating Mutation-Positive (EGFRm+) Advanced Non-Small-Cell Lung Cancer (NSCLC) Who Have Acquired Resistance to an EGFR Tyrosine Kinase Inhibitor (TKI)

November 12, 2024 updated by: Astellas Pharma Global Development, Inc.

A Phase 1b/2 Study of ASP2215 in Combination With Erlotinib in Subjects With EGFR Activating Mutation-Positive (EGFRm+) Advanced NSCLC Who Have Acquired Resistance to an EGFR Tyrosine Kinase Inhibitor (TKI)

The purpose of the Phase 1b part of the study was to evaluate the safety and tolerability of ASP2215 in combination with erlotinib and determine the recommended phase 2 dose (RP2D) of ASP2215. The purpose of the Phase 2 part of the study was to evaluate the objective response rate (ORR) of the RP2D of ASP2215 in combination with erlotinib.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

No patients were enrolled in the Phase 2 part of the study. Phase 2 endpoints were not analyzed.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

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

Study Locations

  • Japan
      • Fukuoka Minami-ku, Fukuoka, Japan
        • Site JP81004
      • Osakasayama, Osaka, Japan
        • Site JP81005
      • Suntogun Nagaizumicho,Shizuoka, Japan
        • Site JP81003
      • Tokyo, Japan
        • Site JP81002

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Gilteritinib 120mg + Erlotinib 150mg
Gilteritinib was administered in combination with erlotinib orally once daily.
Drug: Gilteritinib
oral
Drug: Erlotinib
oral
Other Names:
  • Tarceva
Experimental: Gilteritinib 80mg+ Erlotinib 150mg
Gilteritinib was administered in combination with erlotinib orally once daily.
Drug: Gilteritinib
oral
Drug: Erlotinib
oral
Other Names:
  • Tarceva

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Dose Limiting Toxicities (DLTs)
Time Frame: Cycle 1 and Cycle ≥2 (up to 141 days)
Cycle 1 and Cycle ≥2 (up to 141 days)
Number of Participants With Adverse Events
Time Frame: From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Treatment-emergent adverse events (TEAE) was defined as an adverse event (AE) that started after administration of the study drugs and occurred within 30 days of the last dose of the study drugs. If a participant experienced an event both during the preinvestigational period and during the investigational period, the event was considered a TEAE only if it worsened in severity.
From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Area Under the Concentration-time Curve at 24 Hours (AUC24) for Gilteritinib
Time Frame: 0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Days 1 and 28 of cycle 1
0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Days 1 and 28 of cycle 1
Maximum Concentration (Cmax) for Gilteritinib
Time Frame: 0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Days 1 and 28 of cycle 1
0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Days 1 and 28 of cycle 1
Time After Dosing When Cmax Occurs (Tmax) for Gilteritinib
Time Frame: 0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Days 1 and 28 of cycle 1
0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Days 1 and 28 of cycle 1
Concentration Immediately Prior to Dosing at Multiple Dosing (Ctrough) of Gilteritinib
Time Frame: Predose on Day 1, 3, 8, 15, 22, 28 of cycle 1, Day 1 of cycle 3 and Day 1 of cycle 4
All participants in Gilteritinib 120 mg + Erlotinib 150 mg group discontinued before cycle 3.
Predose on Day 1, 3, 8, 15, 22, 28 of cycle 1, Day 1 of cycle 3 and Day 1 of cycle 4
AUC24 of Erlotinib
Time Frame: 0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Day 28 of cycle 1
0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Day 28 of cycle 1
Cmax of Erlotinib
Time Frame: 0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Day 28 of cycle 1
0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Day 28 of cycle 1
Tmax of Erlotinib
Time Frame: 0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Day 28 of cycle 1
0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Day 28 of cycle 1
Ctrough of Erlotinib
Time Frame: Day 8, 15, 22, 28 of cycle 1
Day 8, 15, 22, 28 of cycle 1
Objective Response Rate (ORR) in Phase 1b
Time Frame: End of treatment (approximately 4 months)
ORR was defined as Objective Response Rate (ORR) was the proportion of patients whose best overall response was complete response (CR) or partial response (PR) per RECIST version 1.1. Only patients with measurable disease at baseline were to be included in the analysis of ORR.
End of treatment (approximately 4 months)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Astellas Pharma Global Development, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Senior Medical Director, Astellas Pharma Global Development, Inc.

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.

Helpful Links

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 8, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 28, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 28, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 8, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 13, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 27, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2215-CL-5101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

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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