Patritumab Deruxtecan for Epidermal Growth Factor Receptor Exon 19 Deletion

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Epidermal Growth Factor Receptor Exon 19 Deletion+2 MorePatritumab Deruxtecan - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug to see if it's effective and safe for patients with a certain type of lung cancer.

Eligible Conditions
  • Epidermal Growth Factor Receptor L858R Mutation
  • Epidermal Growth Factor Receptor Exon 19 Deletion
  • Non-Small Cell Lung Cancer

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 17 Secondary · Reporting Duration: Baseline up to approximately 49 months

Month 49
Clinical Benefit Rate (CBR) as Assessed by Blinded Independent Central Review and Investigator Review Based on RECIST v1.1
Disease Control Rate (DCR) as Assessed by Blinded Independent Central Review and Investigator Review Based on RECIST v1.1
Duration of Response (DoR) as Assessed by Blinded Independent Central Review and Investigator Review Based on RECIST v1.1
Mean Change from Baseline in EuroQol Questionnaire-5 dimensions-5 levels (EQ-5D-5L)
Mean Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)
Mean Change from Baseline in Non-small Cell Lung Cancer - Symptom Assessment Questionnaire
Mean Change from Baseline in Patient's Global Impression of Change
Mean Change from Baseline in Patient's Global Impression of Severity
Mean Change from Baseline in Patient's Global Impression of Treatment Tolerability
Number of Participants With Treatment-emergent Adverse Events
Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review and Investigator Review Based on RECIST v1.1
Overall Survival (OS)
Percentage of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline)
Percentage of Participants Who Have Treatment-emergent ADA
Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review Based on RECIST v1.1
Progression-free Survival (PFS) as Assessed by Investigator Review Based on RECIST v1.1
Progression-free Survival (PFS) as Assessed by Local Standard Clinical Practice
Time to Response (TTR) as Assessed by Blinded Independent Central Review and Investigator Review Based on RECIST v1.1

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Platinum-based chemotherapy
1 of 2
Patritumab deruxtecan
1 of 2

Active Control

Experimental Treatment

560 Total Participants · 2 Treatment Groups

Primary Treatment: Patritumab Deruxtecan · No Placebo Group · Phase 3

Patritumab deruxtecan
Drug
Experimental Group · 1 Intervention: Patritumab Deruxtecan · Intervention Types: Drug
Platinum-based chemotherapy
Drug
ActiveComparator Group · 1 Intervention: Platinum-based chemotherapy · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline up to approximately 49 months

Who is running the clinical trial?

Daiichi Sankyo, Inc.Lead Sponsor
359 Previous Clinical Trials
341,140 Total Patients Enrolled
Global Clinical LeaderStudy DirectorDaiichi Sankyo, Inc.
151 Previous Clinical Trials
74,851 Total Patients Enrolled
Clinical ScientistStudy ChairDaiichi Sankyo, Inc.
2 Previous Clinical Trials
2,531 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are a male or female aged ≥18 years.
You have non-squamous NSCLC that is not amenable to curative surgery or radiation.
You have a tumor that is EGFR-positive and has an EGFR-activating mutation.
You have received 1 or 2 prior line(s) of an approved EGFR TKI treatment in the metastatic or locally advanced setting, which must include a third -generation EGFR TKI.
You have at least 1 measurable lesion as per RECIST v1.1 by Investigator assessment.
You are willing to have a tumor biopsy or provide recently obtained tumor tissue.
You have an ECOG PS of 0 or 1.

Who else is applying?

How old are they?
18 - 65100.0%
What site did they apply to?
Innovative Clinical Research Institute100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria50.0%
Met criteria50.0%