A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of Anvumetostat in Subjects With Methylthioadenosine Phosphorylase (MTAP)-Deleted Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC)

New Lung Cancer Drug Trial for Advanced NSCLC Patients

NCT: NCT06593522 · Status: RECRUITING · Phase: Phase 2 · Sponsor: Amgen · Started: 2024-12-26 · Est. Completion: 2030-11-29

Plain English Summary

A Phase 2 Study of Anvumetostat in Participants With MTAP-deleted Advanced NSCLC (MTAPESTRY 201) is a Phase 2 clinical trial sponsored by Amgen studying MTAP-deleted NSCLC. This trial tests a new drug called anvumetostat for advanced non-small cell lung cancer (NSCLC) that has a specific genetic marker (MTAP-deleted). It is for patients with this specific type of lung cancer who have already been treated with at least one other therapy. Participation involves taking the study drug, anvumetostat, and undergoing regular medical check-ups and scans. Standard treatment options for this condition include chemotherapy, immunotherapy, and targeted therapies, depending on the specific genetic makeup of the tumor. The trial aims to enroll 200 participants.

Official Summary

The main objective of the study is to characterize safety and efficacy of 2 dose levels of anvumetostat by investigator, and to evaluate anvumetostat monotherapy efficacy by Blinded Independent Central Review (BICR).

Who Can Participate

Here is what you need to know about eligibility for this trial. Patients with non-small cell lung cancer (NSCLC) that has spread or cannot be surgically removed and has a specific genetic deletion (MTAP-deleted). Must have received at least one prior treatment for their advanced cancer. Patients with treated brain metastases or small, untreated, asymptomatic brain metastases may be eligible. Cannot have certain other specific genetic mutations that can be treated with targeted therapies, or have had major surgery recently. This trial is studying MTAP-deleted NSCLC, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures will tell us how well anvumetostat shrinks tumors and how safe it is, helping to determine if it's an effective new treatment option. The specific primary outcome measures are: Objective Response (OR) per RECIST 1.1 (Up to 35 months); Objective response (OR) Measured by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) and Assessed per Response Evaluation Criteria in Solid Tumors v1.1 (RECIST 1.1) (Up to 35 months); Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) (Up to 35 months); Number of Participants Experiencing Events of Interest (EOIs) (Up to 35 months); Maximum Concentration (Cmax) of anvumetostat (Cycle 1: Day 1 and Day 15 pre-dose, 0.5 hours, 1 hour, 2 hours, 4 hours, and 6 hours post-dose; Cycle 2: Day 1 and Day 15 pre-dose; Cycles 3-5: Day 1 pre-dose). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial addresses a significant unmet need for patients with MTAP-deleted NSCLC, a subset of lung cancer that may not respond well to current standard treatments. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets MTAP-deleted NSCLC, where improved treatment options are needed.

Investor Insight

This trial is investigating a novel therapy for a specific lung cancer subtype, potentially opening a new market segment if successful, with Amgen as a major sponsor. Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor if your lung cancer is MTAP-deleted and if this trial is a good fit for you. Be prepared for regular clinic visits for drug administration, blood tests, and imaging scans to monitor your condition. Understand that you will be randomly assigned to receive the study drug, and your doctor will be informed of your treatment. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

Inclusion Criteria:

* Histologically or cytologically confirmed metastatic or unresectable locally advanced MTAP-deleted (Homozygous deletion of MTAP) NSCLC
* Participants will have received and progressed or experienced disease recurrence on or after receiving at least 1 prior systemic therapy for locally advanced and unresectable or metastatic disease.
* Either an archival tissue sample or an archival block must be available.
* Life expectancy of greater than 3 months, in the opinion of the investigator.
* Participants who have had brain metastases and have been appropriately treated with radiation therapy or surgery ending at least 14 days before study day 1 are eligible.
* Participants with untreated asymptomatic brain metastases smaller or equal to 2 cm in size (per lesion if more than one) and not requiring corticosteroid treatment are eligible.

Exclusion Criteria:

Disease Related

• Tumors harboring the following mutations amenable to targeted therapies: epidermal growth factor receptor (EGFR), ALK receptor tyrosine kinase (ALK), ROS proto-oncogene 1 (ROS1), neurotrophic tyrosine receptor kinase (NTRK), MET proto-oncogene (MET), B-Raf proto-oncogene (BRAF), RET proto-oncogene (RET), Human epidermal growth factor receptor 2 (HER2/ERBB2), KRAS proto-oncogene G12C (KRAS G12C).

Other Medical Conditions

* Major surgery within 28 days of study day 1.
* Untreated symptomatic central nervous system (CNS) metastatic disease regardless of size or asymptomatic brain metastases greater than 2 cm per lesion.

Trial Locations

Frequently Asked Questions

What is clinical trial NCT06593522?

NCT06593522 is a Phase 2 INTERVENTIONAL study titled "A Phase 2 Study of Anvumetostat in Participants With MTAP-deleted Advanced NSCLC (MTAPESTRY 201)." It is currently recruiting and is sponsored by Amgen. The trial targets enrollment of 200 participants.

What conditions does NCT06593522 study?

This trial investigates treatments for MTAP-deleted NSCLC. The primary condition under study is MTAP-deleted NSCLC.

What treatments are being tested in NCT06593522?

The interventions being studied include: anvumetostat (DRUG). Film-coated tablet

What does Phase 2 mean for NCT06593522?

Phase 2 trials test whether the treatment works for the intended condition. They involve 100-300 patients and continue to evaluate safety while measuring effectiveness.

What is the current status of NCT06593522?

This trial is currently "Recruiting." It started on 2024-12-26. The estimated completion date is 2030-11-29.

Who is sponsoring NCT06593522?

NCT06593522 is sponsored by Amgen. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT06593522?

The trial aims to enroll 200 participants. The trial is currently recruiting and accepting new participants.

How is NCT06593522 designed?

This is a interventional study, uses randomized allocation, follows a sequential design, employs none masking.

What are the primary outcomes being measured in NCT06593522?

The primary outcome measures are: Objective Response (OR) per RECIST 1.1 (Up to 35 months); Objective response (OR) Measured by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) and Assessed per Response Evaluation Criteria in Solid Tumors v1.1 (RECIST 1.1) (Up to 35 months); Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) (Up to 35 months); Number of Participants Experiencing Events of Interest (EOIs) (Up to 35 months); Maximum Concentration (Cmax) of anvumetostat (Cycle 1: Day 1 and Day 15 pre-dose, 0.5 hours, 1 hour, 2 hours, 4 hours, and 6 hours post-dose; Cycle 2: Day 1 and Day 15 pre-dose; Cycles 3-5: Day 1 pre-dose). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT06593522 being conducted?

This trial is being conducted at 20 sites, including Duarte, California; Los Angeles, California; Denver, Colorado; Norwich, Connecticut and 16 more sites (United States).

Where can I find official information about NCT06593522?

The official record for NCT06593522 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06593522. This government database provides the most up-to-date and detailed information about the trial.

What is NCT06593522 testing in simple terms?

This trial tests a new drug called anvumetostat for advanced non-small cell lung cancer (NSCLC) that has a specific genetic marker (MTAP-deleted). It is for patients with this specific type of lung cancer who have already been treated with at least one other therapy.

Why is this trial significant?

This trial addresses a significant unmet need for patients with MTAP-deleted NSCLC, a subset of lung cancer that may not respond well to current standard treatments.

What are the potential risks of participating in NCT06593522?

Common side effects may include fatigue, nausea, and changes in blood counts. Specific risks related to anvumetostat will be discussed with you by the study team. The study involves regular monitoring for any adverse events or side effects. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT06593522?

Ask your doctor if your lung cancer is MTAP-deleted and if this trial is a good fit for you. Be prepared for regular clinic visits for drug administration, blood tests, and imaging scans to monitor your condition. Understand that you will be randomly assigned to receive the study drug, and your doctor will be informed of your treatment. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT06593522 signal from an investment perspective?

This trial is investigating a novel therapy for a specific lung cancer subtype, potentially opening a new market segment if successful, with Amgen as a major sponsor. This is a Phase 2 trial, which is focused on confirming efficacy before larger pivotal studies.

What happens if the treatment in this trial doesn't work?

Participation involves taking the study drug, anvumetostat, and undergoing regular medical check-ups and scans. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.