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MTA-cooperative PRMT5 inhibitor

Subprotocol A: NSCLC Arm B for Non-Small Cell Lung Cancer

Phase 1

Recruiting

Research Sponsored by Amgen

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).

Able to swallow and retain PO administered study treatment.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 3 years

Awards & highlights

Study Summary

This trial is trying to find the highest safe dose of a drug called AMG 193 when given with other treatments to adults with certain types of lung cancer. The study also wants to see how safe

Who is the study for?

This trial is for adults with advanced thoracic tumors, including non-small cell lung cancer, that have a specific genetic change (homozygous MTAP-deletion). Participants must be able to swallow pills and have measurable disease. They need available tumor tissue samples or agree to a biopsy before starting treatment.Check my eligibility

What is being tested?

The study tests the drug AMG 193 alone or combined with other therapies like Paclitaxel, Carboplatin, Pemetrexed, Sotorasib, and Pembrolizumab. It aims to find the highest dose patients can take without serious side effects and assess safety in those with certain thoracic tumors.See study design

What are the potential side effects?

Possible side effects of AMG 193 and combination therapies may include reactions at the infusion site, fatigue, nausea, blood count changes affecting immunity or clotting risk. The exact side effects will depend on which drugs are used together.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am at least 18 years old or the legal age in my country.

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I can swallow and keep down oral medication.

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My cancer has a specific genetic change called MTAP-deletion.

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My cancer is mainly squamous cell type.

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My lung cancer diagnosis was confirmed through lab tests.

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My lung cancer is mainly non-squamous.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants Experiencing Dose Limiting Toxicities (DLT)

Number of Participants Experiencing Serious Adverse Events (SAE)

Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE)

Secondary outcome measures

Area Under the Plasma Concentration-time Curve (AUC) of AMG 193

Disease Control (DC) per RECIST v1.1

Duration of Response (DOR) per RECIST v1.1

+10 more

Trial Design

5Treatment groups

Experimental Treatment

Group I: Subprotocol C: NSCLC With Brain MetastasesExperimental Treatment1 Intervention

Participants with MTAP-deleted NSCLC with brain metastases will receive AMG 193 PO

Group II: Subprotocol B: NSCLC With KRasG12C MutationExperimental Treatment2 Interventions

Participants with MTAP-deleted NSCLC and KRasG12C mutation will receive a combination of AM193 and sotorasib PO

Group III: Subprotocol A: Non-Small Cell Lung Cancer (NSCLC) Arm AExperimental Treatment4 Interventions

Participants with MTAP-deleted NSCLC will receive a regimen of AMG 193 orally (PO) and carboplatin, paclitaxel, and pembrolizumab intravenously (IV)

Group IV: Subprotocol A: NSCLC Arm CExperimental Treatment2 Interventions

Participants with MTAP-deleted NSCLC will receive a combination of AMG 193 PO and pembrolizumab IV

Group V: Subprotocol A: NSCLC Arm BExperimental Treatment4 Interventions

Participants with MTAP-deleted NSCLC will receive a regimen of AMG 193 PO and carboplatin, pemetrexed, and pembrolizumab IV

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

2011

Completed Phase 4

~5380

Pemetrexed

2014

Completed Phase 3

~5250

Carboplatin

2014

Completed Phase 3

~6670

Sotorasib

2021

Completed Phase 1

~370

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor

1,380 Previous Clinical Trials

1,379,121 Total Patients Enrolled

MDStudy DirectorAmgen

925 Previous Clinical Trials

926,144 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the clinical trial allowing participation of individuals older than 45 years?

"Participants aged over 18 years and below the centenarian milestone are being sought for enrollment in this investigation."

Answered by AI

What is the current number of participants being recruited for this research endeavor?

"Yes, the details on clinicaltrials.gov suggest that recruitment for this study is currently ongoing. The trial was initially posted on March 6th, 2024, with the most recent update made on April 23rd, 2024. Enrollment of approximately 500 participants will occur at a single site."

Answered by AI

Is the enrollment process currently in progress for participants of this research study?

"The clinical trial, currently seeking participants, was initially listed on 6/3/2024 and last updated on 4/23/2024 according to details available on clinicaltrials.gov."

Answered by AI

Has the FDA given its approval for Subprotocol A: NSCLC Arm C?

"The safety rating for Subprotocol A: NSCLC Arm C is 1 according to our evaluation at Power. This Phase 1 trial has limited evidence supporting both the safety and effectiveness of the treatment."

Answered by AI

Do I meet the necessary criteria to participate in this medical trial?

"This trial seeks to enroll 500 individuals aged between 18 and 100 with a diagnosis of non-small cell lung cancer. Essential requirements for participation include meeting Subprotocols A, B, and C criteria; being at least 18 years old (or reaching the legal age threshold in their respective country if it surpasses 18 years); displaying homozygous MTAP-deletion; capable of orally ingesting and retaining the study medication administered via mouth; presenting measurable disease according to RECIST v1.1 guidelines; requiring availability of tumor tissue sample or archival block for Subprotocol A participants - those lacking archived samples may still be considered upon"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

AMG 193 Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol)

2024. "AMG 193 Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06333951.

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