At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Pembrolizumab (biological), sac-TMT (biological), Carboplatin (drug), Paclitaxel (drug)
- How long the study runs
- Study runs about 86 months (dates as stated)
- About the drug or intervention
- Pembrolizumab — biological: Intravenous (IV) infusion · sac-TMT — biological: IV infusion · Carboplatin — drug: Participants receive AUC 6 or AUC 5 mg/mL/min IV infusion on Day 1 of each 21-day cycle for 4 cycles as background therapy during the study. · Paclitaxel — drug: Participants receive 200 mg/m\^2 or 175 mg/m\^2 IV infusion on Day 1 of each 21-day cycle for 4 cycles as background therapy during the study. · Nab-paclitaxel — drug: Participants receive 100 mg/m\^2 IV infusion on Days 1, 8 and 15 of each 21-day cycle for 4 cycles as background therapy during the study.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 851
- Started
- 2024-06-10
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for non-small cell lung cancer
- • Phase3 - 851 participants
- • This is a phase 3 study of pembrolizumab in combination with carboplatin/taxane (paclitaxel or nab-paclitaxel) followed by pembrolizumab with or without maintenance sacituzumab tirumotecan (sac-TMT; MK-2870) in first-line treatment of metastatic squamous non-small cell lung cancer
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with non-small cell lung cancer
Where?
- • Londonderry - North West Cancer Centre ( Site 1908)
- • Torquay - Torbay Hospital ( Site 1906)
- • London - St Bartholomew's Hospital ( Site 1901)
- • Nottingham - City Hospital, Nottingham University Hospitals NHS Trust-NCCTT ( Site 1911)
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This is a phase 3 study of pembrolizumab in combination with carboplatin/taxane (paclitaxel or nab-paclitaxel) followed by pembrolizumab with or without maintenance sacituzumab tirumotecan (sac-TMT; MK-2870) in first-line treatment of metastatic squamous non-small cell lung cancer. It is hypothesized that pembrolizumab with maintenance sacituzumab tirumotecan is superior to pembrolizumab without sacituzumab tirumotecan maintenance with respect to overall survival (OS).
More detail
All participants undergo an initial induction phase of four cycles, each cycle consisting of pembrolizumab every 3 weeks (q3w) + carboplatin q3w + paclitaxel q3w or nabpaclitaxel weekly. Participants are then randomly assigned to pembrolizumab maintenance vs. pembrolizumab + sac-TMT maintenance.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ well controlled HIV on antiretroviral therapy (ART)
What the study is looking for
- ✓confirmed by testing a sample diagnosis of squamous non-small cell lung cancer (NSCLC) \[Stage IV: M1a,...
- ✓cancer that can be measured on scans per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 as assessed by the local site...
- ✓Has life expectancy ≥3 months
- ✓Has activity scale Performance Status (ECOG PS) score of 0 or 1 assessed within 7 days prior to...
- ✓Archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not...
Who cannot take part
- ✗Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
- ✗History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal...
- ✗Active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel...
- ✗HIV-infected participants who have been newly diagnosed or with a history of Kaposi's sarcoma and/or Multicentric...
- ✗Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-targeted antidrug conjugate (ADC)
See the full criteria
Where Is This Study? (4 UK sites)
North West Cancer Centre ( Site 1908)
Londonderry BT47 6SB, United Kingdom
Torbay Hospital ( Site 1906)
Torquay TQ2 7AA, United Kingdom
St Bartholomew's Hospital ( Site 1901)
London EC1A7BE, United Kingdom
City Hospital, Nottingham University Hospitals NHS Trust-NCCTT ( Site 1911)
Nottingham NG5 1PB, United Kingdom
How to Get in Touch
Toll Free Number
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