Trial purpose
Cancer treatment
Tumor type
Lung cancer
Age
18+
Clinical summary
Summary
Eligible participants will be randomly allocated (by chance) to one of two treatment arms.
In the Experimental Arm, participants will receive an antibody-drug conjugate called Sacituzumab tirumotecan. Participants will receive Sacituzumab tirumotecan via intravenous (IV) infusion on Days 1, 15 and 29 of each 6-week treatment 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.
In the Active Comparator Arm participants will receive chemotherapy (either docetaxel or pemetrexed). Both will be administered via IV infusion on Days 1 and 22 of every 6-week cycle.
Conditions
This trial is treating people with advanced or metastatic nonsquamous non-small cell lung cancer with EGFR mutations or other genomic alterations
Eligibility
Inclusion
- 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
- 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.
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- Your cancer has not spread to other parts of the body (localised).
- Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You have had a certain type of treatment or surgical procedure.
Exclusion
- You are currently being treated on a clinical trial.
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:
- NCT06074588 *
- 2023-503539-16-00 *
- 2870-004; JRCT2031240108; U1111-1287-4913
Trial sponsor
Merck Sharp & Dohme LLC
Scientific Title
A Randomized, Open-label, Phase 3 Study of MK-2870 vs Chemotherapy (Docetaxel or Pemetrexed) in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations or Other Genomic Alterations
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