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
- Sacituzumab tirumotecan (biological), Pembrolizumab (biological), Cisplatin (drug), Pemetrexed (drug)
- How long the study runs
- Study runs about 126 months (dates as stated)
- About the drug or intervention
- Sacituzumab tirumotecan — biological: Sacituzumab tirumotecan to be administered as 4mg/kg IV infusion q2w for up to 24 weeks · Pembrolizumab — biological: Pembrolizumab to be administered 400mg by IV infusion q6w for up to 42 weeks · Cisplatin — drug: Cisplatin is administered as 75 mg/m\^2 IV infusion q3w for up to 12 weeks as background treatment in neoadjuvant phase · Pemetrexed — drug: Pemetrexed will be administered in the neoadjuvant phase as 500 mg/m\^2 IV infusion q3w for up to 12 weeks as background treatment in participants with nonsquamous NSCLC. · Gemcitabine — drug: Gemcitabine will be administered in the neoadjuvant phase as 1000 mg/m\^2 or 1250 mg/m\^2 IV infusion on day 1 and day 8 q3w for up to 24 weeks as background treatment in participants with squamous NSCLC. · Carboplatin — drug: Carboplatin will be administered in the neoadjuvant phase as AUC 5 mg/mL/min or AUC 6 mg/mL/min IV infusion q3w for up to 12 weeks as background treatment. · Paclitaxel — drug: Paclitaxel will be administered in the neoadjuvant phase as 175 mg/m\^2 or 200 mg/m\^2 IV infusion q3w for up to 12 weeks as background treatment. · Rescue medication — drug: Participants are permitted to take rescue medications to prevent hypersensitivity and/or infusion reactions as a premedication to study treatment.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 780
- Started
- 2024-04-03
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for non small cell lung cancer
- • Phase3 - 780 participants
- • This study will assess if adding sacituzumab tirumotecan with pembrolizumab after surgery is effective in treating NSCLC for participants not achieving pathological complete response
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with non small cell lung cancer
Where?
- • Cambridge - Addenbrooke's Hospital ( Site 3217)
- • Northwood - Mount Vernon Hospital ( Site 3218)
- • London - St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 3203)
- • Oxford - Churchill Hospital ( Site 3219)
- • +1 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This study will assess if adding sacituzumab tirumotecan with pembrolizumab after surgery is effective in treating NSCLC for participants not achieving pathological complete response. The primary hypothesis of this study is sacituzumab tirumotecan plus pembrolizumab is superior to pembrolizumab monotherapy with respect to disease free survival (DFS) as assessed by blinded independent central review (BICR).
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:
- ✓ recovered to ≤Grade 1 or baseline
- ✓ well controlled HIV on antiretroviral therapy (ART)
What the study is looking for
- ✓Has confirmation that either epidermal growth factor receptor (EGFR)-directed or anaplastic lymphoma kinase...
- ✓Is able to undergo surgery based on opinion of investigator after consultation with surgeon
- ✓Is able to receive before surgery pembrolizumab and platinum-based doublet drug treatment
- ✓Applies to screening for the after surgery period only, before randomization: Has not achieved pathological complete...
- ✓Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
Who cannot take part
- ✗Has one of the following tumor locations/types:
- ✗NSCLC involving the superior sulcus
- ✗Large cell neuro-endocrine cancer (LCNEC)
- ✗Sarcomatoid tumor
- ✗Diagnosis of SCLC or, for mixed tumors, presence of small cell elements
See the full criteria
Where Is This Study? (5 UK sites)
Addenbrooke's Hospital ( Site 3217)
Cambridge CB2 2QQ, United Kingdom
Mount Vernon Hospital ( Site 3218)
Northwood HA6 2RN, United Kingdom
St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 3203)
London EC1A 7BE, United Kingdom
Churchill Hospital ( Site 3219)
Oxford OX3 7LE, United Kingdom
Freeman Hospital-Northern Centre for Cancer Care ( Site 3212)
Newcastle upon Tyne NE7 7DN, United Kingdom
How to Get in Touch
Toll Free Number
Sponsor contactCONTACT
