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Alkylating agents

Sacituzumab Tirumotecan vs Standard Therapy for 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 confirmed diagnosis of advanced-stage nonsquamous non-small cell lung cancer (NSCLC)

Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to Grade <1 or baseline

Must not have

Active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease

Active infection requiring systemic therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 6 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

"This trial is comparing two different treatments for advanced lung cancer with a specific genetic mutation. The study aims to see if one treatment, sacituzumab tirumotecan, is more effective than

Who is the study for?

This trial is for adults with advanced-stage nonsquamous NSCLC that has worsened despite EGFR tyrosine kinase inhibitors. Candidates must have a life expectancy of at least 3 months, controlled HIV or Hepatitis B/C if present, and recovered from previous cancer therapy side effects.

What is being tested?

The study compares sacituzumab tirumotecan to the combination of pemetrexed and carboplatin in treating advanced non-squamous NSCLC with EGFR mutations. It aims to see which treatment leads to longer survival without disease progression.

What are the potential side effects?

Potential side effects include reactions related to infusion, liver issues due to hepatitis history (if applicable), immune system suppression, and typical chemotherapy-related symptoms like fatigue, nausea, and blood cell count changes.

Eligibility Criteria

Inclusion Criteria

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

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My lung cancer is advanced and not squamous cell type.

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I have recovered from side effects of previous cancer treatments.

Exclusion Criteria

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

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I have or had inflammatory bowel disease and need or needed drugs to suppress my immune system.

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I am currently on medication for an infection.

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I had radiation therapy less than 2 weeks ago or need steroids for radiation side effects.

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My cancer has spread to my brain or spinal cord.

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I have or had lung inflammation that needed steroids.

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I have received an organ or tissue transplant from another person.

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

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I have a severe eye condition that affects my cornea or eyelid glands.

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My lung cancer is mainly squamous cell type.

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I do not have severe numbness or pain in my hands or feet.

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I am HIV-positive with a history of Kaposi's sarcoma or Castleman's Disease.

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)

Progression-Free Survival (PFS)

Secondary study objectives

Change From Baseline in the Dyspnea (Item 8) Score, on the EORTC QLQ-C30

Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score

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

+9 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 Treatment6 Interventions

Participants receive 4 mg/kg sacituzumab tirumotecan via intravenous (IV) infusion every 2 weeks (Days 1, 15, and 29 of every 6-week cycle) until discontinuation criteria is met.

Group II: Pemetrexed Plus CarboplatinActive Control2 Interventions

Participants receive, via IV infusion, 500 mg/m2 pemetrexed every 3 weeks (Days 1 and 22 of every 6-week cycle) plus area under the curve (AUC) 5 mg/mL\*min carboplatin every 3 weeks (Days 1 and 22 of every 6-week cycle for 4 doses), then 500 mg/m2 pemetrexed every 3 weeks until discontinuation criteria is met.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Antihistamine

2016

Completed Phase 3

~1100

0 / 13Eligibility criteria met