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Anti-metabolites

MK-2870 for Non-Small Cell Lung Cancer

Q: What goals does this clinical examination seek to attain?

<p>The Merck Sharp &#x26; Dohme LLC trial sponsor has announced that Progression-free Survival (PFS) of participants with Non-<a href="https://www.withpower.com/clinical-trials/small-cell-lung-cancer">Small cell lung cancer</a> (<a href="https://www.withpower.com/clinical-trials/nsclc">NSCLC</a>) harbouring Epidermal Growth Factor Receptor Mutations will be the primary outcome, measured over a period maxing out at 6 years. Additionally, secondary outcomes include changes in Global Health Status/Quality of Life Score (EORTC Quality of Life Questionnaire-Core 30 Items 29 and 30), Cough Severity (EORTC Quality of Life Questionnaire -Lung Cancer 13 Item 31), and Dyspnea Intensity Scores (EOR</p>

Phase 3

Recruiting

Research Sponsored by Merck Sharp & Dohme LLC

Eligibility Criteria Checklist

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

Must have

Histologically- or cytologically-documented advanced (Stage III not eligible for resection or curative radiation) or metastatic non-squamous NSCLC with specific mutations

Documentation of locally assessed radiological disease progression while on or after last treatment based on Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 6 years

Awards & highlights

Study Summary

This trial tests if a drug called MK-2870 is better than chemotherapy for treating advanced NSCLC with EGFR mutations or other genomic alterations.

Who is the study for?

This trial is for adults with advanced or metastatic non-squamous NSCLC who have specific mutations and have already tried some treatments. They should be relatively healthy (ECOG status of 0 or 1), not have certain infections, and must not have had recent vaccinations or other cancer treatments within the last month.Check my eligibility

What is being tested?

The study tests MK-2870 against standard chemotherapy drugs (docetaxel or pemetrexed) in patients with certain genetic changes in their lung cancer. The goal is to see if MK-2870 can improve survival without the disease getting worse compared to chemotherapy.See study design

What are the potential side effects?

While side effects are not detailed here, common ones from similar trials include fatigue, nausea, hair loss from chemotherapy, and potential infusion reactions from MK-2870. Side effects vary by individual.

Eligibility Criteria

Inclusion Criteria

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

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My advanced lung cancer is non-squamous and has specific mutations.

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My cancer has grown despite treatment, as shown by scans.

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I've had specific lung cancer treatments, including a targeted therapy for a certain mutation.

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I have provided a sample of my tumor that has not been treated with radiation.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My side effects from previous cancer treatments have mostly gone away.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 6 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

Overall Survival (OS) of Participants with NSCLC with EGFR mutations

Progression-free Survival (PFS) of Participants with NSCLC with Epidermal Growth Factor Receptor (EGFR) Mutations

Secondary outcome measures

Change in Score from Baseline in Chest Pain (EORTC QLQ-LC13 Item 40)

Change in Score from Baseline in Cough (EORTC Quality of Life Questionnaire-Lung Cancer 13 [QLQ-LC13] Item 31)

Change in Score from Baseline in Dyspnea Score (EORTC QLQ-C30 Item 8)

+12 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Sacituzumab tirumotecanExperimental Treatment1 Intervention

Participants will receive 4 mg/kg of sacituzumab tirumotecan via intravenous (IV) infusion on Days 1, 15 and 29 of each 6-week cycle. Additionally, participants receive diphenhydramine (or equivalent), an H2 antagonist of investigator's choice, acetaminophen (or equivalent), and dexamethasone (or equivalent) per each drug's product label prior to the first 4 infusions of sacituzumab tirumotecan. At subsequent infusions, the H2 antagonist and dexamethasone are optional, at the discretion of the investigator.

Group II: ChemotherapyActive Control2 Interventions

Participants will receive 75 mg/m^2 of docetaxel or 500 mg/m^2 of pemetrexed by IV infusion on Days 1 and 22 of every 6-week cycle.

0 / 6Eligibility criteria met

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Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor

3,892 Previous Clinical Trials

5,060,590 Total Patients Enrolled

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,777 Previous Clinical Trials

8,063,848 Total Patients Enrolled

Frequently Asked Questions

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

What is the upper bound of individuals who are partaking in this examination?

"Yes, the data on clinicaltrials.gov validates that this trial is actively seeking participants. The study was posted for the first time on November 12th 2023 and last updated eleven days later. This research endeavour requires 556 individuals to be recruited from 3 separate sites."

Answered by AI

Has MK-2870 been granted regulatory authorization by the FDA?

"Due to the available evidence of efficacy and safety, we at Power have graded MK-2870's risk profile as a 3 on a 1 to 3 scale."

Answered by AI

Are there any openings available for participants in this clinical investigation?

"Affirmative. Clinicaltrials.gov confirms that this research is actively recruiting, with the initial postdate being November 12th 2023 and a recent update on November 22nd of the same year. At present, 556 patients are required from three separate sites for successful completion."

Answered by AI

What goals does this clinical examination seek to attain?

"The Merck Sharp & Dohme LLC trial sponsor has announced that Progression-free Survival (PFS) of participants with Non-Small cell lung cancer (NSCLC) harbouring Epidermal Growth Factor Receptor Mutations will be the primary outcome, measured over a period maxing out at 6 years. Additionally, secondary outcomes include changes in Global Health Status/Quality of Life Score (EORTC Quality of Life Questionnaire-Core 30 Items 29 and 30), Cough Severity (EORTC Quality of Life Questionnaire -Lung Cancer 13 Item 31), and Dyspnea Intensity Scores (EOR"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Sacituzumab Tirumotecan (MK-2870) Versus Chemotherapy in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations or Other Genomic Alterations (MK-2870-004)

2023. "Sacituzumab Tirumotecan (MK-2870) Versus Chemotherapy in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations or Other Genomic Alterations (MK-2870-004)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06074588.