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MTA-cooperative PRMT5 inhibitor

AMG 193 + Other Therapies for 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

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.
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.
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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants Experiencing Serious Adverse Events (SAE)
Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE)

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
Pemetrexed
2014
Completed Phase 3
~5550
Pembrolizumab
2017
Completed Phase 2
~2070
Carboplatin
2014
Completed Phase 3
~6120
Paclitaxel
2011
Completed Phase 4
~5810
Sotorasib
2021
Completed Phase 1
~370

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,420 Previous Clinical Trials
1,382,450 Total Patients Enrolled
MDStudy DirectorAmgen
961 Previous Clinical Trials
928,365 Total Patients Enrolled
~333 spots leftby May 2029
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