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Trial Purpose

The purpose of this study is to evaluate sacituzumab tirumotecan versus chemotherapy (docetaxel or pemetrexed) for the treatment of previously-treated non-small cell lung cancer (NSCLC) with exon 19del or exon 21 L858R EGFR mutations (hereafter referred to as EGFR mutations or EGFR-mutated) or any of the follow genomic alterations: ALK gene rearrangements, ROS1 rearrangements, BRAF V600E mutations, NTRK gene fusions, MET exon 14 skipping mutations, RET rearrangements, or less common EGFR point mutations of exon 20 S768I, exon 21 L861Q, or exon 18 G719X mutations. The primary hypothesis is that sacituzumab tirumotecan is superior to chemotherapy with respect to overall survival (OS) in NSCLC with EGFR mutations.

View more trial information on ClinicalTrials.gov
National Trial Reference NumberNational Trial Reference NumberA unique identification code given to each clinical trial record registered on ClinicalTrials.gov. Also called the ClinicalTrials.gov identifier. NCT06074588

MSD Protocol ID

Conditions

Non-small Cell Lung Cancer

Age Range

18+
SexSexSex assigned at birth. Sex is distinct from gender-based eligibility. ALL
Trial PhaseTrial PhaseThe stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the trial’s objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions. 3

Start Date

End Date

2023-11-12

2030-03-11

Study Details

Patient Participation

Only a qualified healthcare professional can determine if you are eligible to take part in a clinical trial.

Conditions

Non-small Cell Lung Cancer

Trial Phase 3

In Phase 3 trials, researchers try to find out if a treatment works in a large number of people, usually about 1,000 to 5,000 participantsResearch participantIn clinical research, a person who qualifies and agrees to participate in a study. Also called volunteer, trial participant. who have the health condition the treatment is intended to treat. In vaccine trials, the participants may be healthy or have diseases or conditions. Phase 3 trials may happen in a doctor’s office, a clinic, or a hospital.

Trial Locations

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What can you do next?

If you think this clinical trial might be a good fit and you are interested in taking part, take the next step to see if you are eligible.

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Contact our Trial Information Center

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Taking part in a clinical trial is an important decision

If you are considering joining a clinical trial, first learn as much as you can about:

  • The investigational medicine that is being studied
  • What the risks and possible benefits are for participants

Talk to your doctor about the clinical trial before you decide to join.

Read our “What to Consider” page for more questions to ask and think about

Clinicaltrials.gov Identifier

NCT06074588

When you talk with your doctor or clinical trial team member, please have the trial identifier number or the EudraCT number available.

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