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Anti-metabolites

MK-2870 for Non-Small Cell Lung Cancer

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

Must not have

Has Grade ≥2 peripheral neuropathy

Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 6 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I experience significant numbness or pain in my hands or feet.

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I have severe dry eye, eyelid inflammation, or corneal disease.

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I do not have uncontrolled heart or brain blood vessel problems.

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I have or had lung inflammation that needed steroids.

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I am HIV-positive and have had Kaposi's sarcoma or Multicentric Castleman's Disease.

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I finished palliative radiotherapy over a week ago and have no side effects requiring steroids.

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I have been treated with a TROP2-targeted therapy before.

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My lung cancer is mainly squamous cell type.

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I am currently on medication for an infection.

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My tumor contains small cell elements.

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I have an active inflammatory bowel disease or a history of it.

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My cancer has the EGFR T790M mutation and I haven't taken osimertinib.

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I have been treated with a specific cancer drug that targets DNA.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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 / 19Eligibility criteria met