Comparing sacituzumab tirumotecan to chemotherapy for advanced lung cancer with specific mutations

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of sacituzumab tirumotecan compared to standard chemotherapy (docetaxel or pemetrexed) in patients with previously treated advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) that has specific genetic mutations. The study focuses on patients with EGFR mutations and other genomic alterations, aiming to determine if sacituzumab tirumotecan can improve progression-free survival and overall survival compared to traditional chemotherapy. Participants must have documented disease progression while on prior treatments and meet specific eligibility criteria regarding their cancer's genetic profile.

Why it matters

Who can join: the full rules

The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

* 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.
* Participants with genome mutations must have received 1 or 2 prior lines of epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI), including a third generation TKI for participants with a T790M mutation; and 1 platinum-based therapy after progression on or after EGFR TKI.
* Measurable disease per RECIST 1.1 as assessed by the local site investigator.
* Archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated has been provided
* Participants who have AEs due to previous anticancer therapies must have recovered to Grade ≤1 or baseline.
* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization.
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy.
* Have an ECOG performance status of 0 or 1 within 3 days before randomization.

Exclusion Criteria:

* Has predominantly squamous cell histology NSCLC.
* Has mixed tumor(s) with small cell elements.
* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease.
* 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.
* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.
* Has an EGFR T790M mutation and has not received a third generation EGFR TKI (eg, osimertinib).
* Received prior systemic anticancer therapy including investigational agents within 4 weeks or 5 half-lives (whichever is shorter) before randomization.
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
* Completed palliative radiotherapy within 7 days of the first dose. Participants must have recovered from all radiation-related toxicities and not require corticosteroids.
* Received radiation therapy to the lung that is \>30 Gy within 6 months of the first dose of study intervention.
* Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-targeted antibody-drug conjugate (ADC).
* Received prior treatment with a topoisomerase I-containing ADC.
* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
* Known additional malignancy that is progressing or has required active treatment within the past 3 years.
* Active infection requiring systemic therapy.
* History of noninfectious pneumonitis/ILD that required steroids or has current pneumonitis/ILD.
* Has known active central nervous system metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 2 weeks, and are off steroids 3 days prior to dosing with study medication.
* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
* Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection.

Where it's running

• UCLA Hematology/Oncology - Santa Monica ( Site 0023)
  Los Angeles, California, United States Recruiting
• Mayo Clinic in Florida-Mayo Clinic Comprehensive Cancer Center ( Site 0001)
  Jacksonville, Florida, United States Recruiting
• Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0003)
  Marietta, Georgia, United States Recruiting
• Karmanos Cancer Institute ( Site 0018)
  Detroit, Michigan, United States Recruiting
• Mayo Clinic in Rochester, Minnesota-Mayo Clinic Comprehensive Cancer Center ( Site 0027)
  Rochester, Minnesota, United States Recruiting
• Hattiesburg Clinic Hematology/Oncology ( Site 0010)
  Hattiesburg, Mississippi, United States Recruiting

+134 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Sacituzumab Tirumotecan plus Pembrolizumab in advanced biliary tract cancer

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• Sacituzumab Govitecan plus Tislelizumab for advanced esophageal cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.