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Efficacy of Triplet Combination With Pembrolizumab, Neratinib, and Paclitaxel as a Second Line Treatment in Recurrent/Advanced Gastric Cancer Having Somatic Human Epidermal Growth Factor Receptor Family (EGFR, HER2, HER3, HER4) Mutations or HER2 Amplification/Overexpression

NCT05512182 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2023-06-15

No results posted yet for this study

Summary

Clinical Indication : HER mutated or HER2 Amplification/Overexpression in Gastric Cancer, 2nd-line Trial Type : Interventional, Open label Treatment Groups : Single arm: Pembrolizumab 200 mg every 3 weeks (Q3W), neratinib at 240 mg once daily (QD), and paclitaxel 175 mg/m2 every 3 weeks (Q3W) Number of trial participants : Approximately 68 patients will be enrolled (with 10% drop-out).

Estimated enrollment period : 24 months Estimated duration of trial : It is estimated that the trial will require approximately 30 months from the time the first patient signs the informed consent until the last patient's last visit.

* First Patient In: Mar 2021
* Last Patient In: Feb 2023
* Last Patient Last Visit: Aug 2023 Duration of Participation : 30 months

Conditions

  • Recurrent/Advanced Gastric Cancer

Interventions

DRUG

Chemotherapy

Pembrolizumab : 200mg/Q3W/IV infusion/Day 1of each 3-week cycle Neratinib : Week 1: 120 mg, Week 2: 160 mg, Week 3 and onwards: 240 mg/QD/Oral/Once daily Paclitaxel : 175mg/m2 /Q3W/IV infusion/Day 1of each 3-week cycle

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Principal Investigators

  • SUN YOUNG RHA · Yonsei Cancer Center, Yonsei University College of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-15
Primary Completion
2023-10-30
Completion
2023-10-30

Countries

  • South Korea

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05512182 on ClinicalTrials.gov