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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

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.Check my eligibility
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.See study design
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 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)
Progression-Free Survival (PFS)
Secondary outcome measures
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

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Sacituzumab tirumotecanExperimental Treatment5 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
~240

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Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,919 Previous Clinical Trials
5,067,743 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,801 Previous Clinical Trials
8,069,810 Total Patients Enrolled
~347 spots leftby Sep 2028