Efficacy of Triplet Combination With Pembrolizumab, Neratinib, and Paclitaxel as a Second Line Tr… (NCT05512182) | Clinical Trial Compass
WithdrawnPhase 2
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
Stopped: No participants enrolled
South Korea0Started 2022-09-15
Plain-language 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
Who can participate
Age range
19 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Has provided written informed consent for the trial.
. Is male or female at least 19 years of age on the day of signing informed consent.
. Has a histologically or cytologically confirmed diagnosis of advanced or metastatic gastric adenocarcinoma (systemic metastasis or locally advanced unresectable gastric cancer). A subject must have previously received 1st line chemotherapy using fluoropyrimidine- or platinum-based regimen and showed progression.
. Has tumors with known activating EGFR, ERBB2, ERBB3, ERBB4 mutations or HER2 amplification by NGS, or HER2 overexpression by IHC or SISH/FISH
. Has a life expectancy of at least 3 months.
. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Have measurable or evaluable disease determined by RECIST 1.1.
. Is able to swallow and retain orally administered medication.
Exclusion criteria
. Have received second line or more of anticancer treatment (not including adjuvant chemotherapy).
. Have multiple cancers (with the exception of completely resected basal cell carcinoma, thyroid cancer, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, and superficial bladder cancer, and any other cancers that have not recurred for at least 5 years).
. Have history of hypersensitivity to anti-HER2, immune-oncology drugs.
. Have brain or leptomeningeal metastases. Patients may be enrolled for the study if they are asymptomatic and require no treatment.
. Have a tumor with an activating KRAS co-mutation.
. Have a history of uncontrollable or significant cardiovascular disease meeting any of the following:
. Have active, unresolved systemic infection requiring treatment.
. Are contraindicated for pembrolizumab, neratinib, or paclitaxel, or have severe hypersensitivity (≥Grade 3) to any of those drugs and/or their excipients.