YL201 plus atezolizumab for newly diagnosed extensive-stage small cell lung cancer
Official title: A Phase Ib/II, Multicenter, Open-Label Study to Evaluate Safety, Efficacy, and Pharmacokinetics of YL201 in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors
Run by MediLink Therapeutics (Suzhou) Co., Ltd. · NCT07407933 · Data updated 2026-11-12
This trial will try YL201 together with atezolizumab to see if the combo is safe and helpful for people with newly diagnosed extensive-stage small cell lung cancer.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 118 (estimated) |
| Sponsor | MediLink Therapeutics (Suzhou) Co., Ltd. Industry-sponsored |
| Drugs / interventions | atezolizumab |
| Locations | 38 sites (Washington D.C., District of Columbia and 37 other locations) |
| Status | Recruiting |
| Started | March 31, 2026 |
| Main results expected | November 2028 |
| Study ends | February 2029 |
| Registry record updated | September 17, 2026 |
| Trial ID | NCT07407933 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (age 18 or older) with histologically or cytologically confirmed extensive-stage SCLC, ECOG performance status 0–1, adequate organ function, and no prior systemic treatment for ES-SCLC are ideal candidates.
✕Probably not a fit
Patients who have had prior systemic therapy for ES-SCLC, prior B7-H3 or topoisomerase I–targeting treatments, active brain metastases, a history of ILD/pneumonitis, or significant cardiac disease are unlikely to qualify or receive benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase Ib/II, multicenter, open-label study combines the antibody–drug conjugate YL201 with the PD-L1 inhibitor atezolizumab in patients with newly diagnosed extensive-stage small cell lung cancer (ES-SCLC). Part 1 is a dose-escalation cohort testing planned YL201 doses of 1.2, 1.6, and 2.0 mg/kg given every three weeks alongside a fixed dose of atezolizumab to characterize safety and tolerability. Part 2 begins with a randomized dose-optimization stage (1:1:1 to the three doses) and then moves to a dose-expansion stage where one or two doses will be selected based on safety, pharmacokinetics, and early efficacy signals. Treatment continues until disease progression, unacceptable toxicity, or withdrawal of consent, with collection of safety, PK, and tumor response data.
Why it matters
Potential benefit: If successful, the combination could provide a more effective treatment option and longer disease control for people with extensive-stage small cell lung cancer.
How similar studies have gone: Atezolizumab has shown benefit when added to chemotherapy in ES-SCLC, but combining it with a B7-H3–targeting ADC like YL201 is a novel approach with limited prior clinical data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1.18 years of age or older. 2. Histologically or cytologically confirmed diagnosis of ES-SCLC 3. Eastern Cooperative Oncology Group performance status of 0 or 1 4. Adequate hematologic and end-organ function Exclusion Criteria: 1. No prior systemic anti-cancer treatment for ES-SCLC 2. No prior treatment targeting B7H3 or topoisomerase I inhibitor 3. No clinically active brain metastases or spinal cord compression 4. No current or history of interstitial lung disease (ILD)/ pneumonitis 5. No clinically significant cardiovascular disease (eg, New York Heart Association class II to IV congestive heart failure) Other protocol-defined inclusion/ exclusion criteria may apply.
Where it's running
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Site 1001
Washington D.C., District of Columbia, United States Recruiting -
Site 1009
Plantation, Florida, United States Recruiting -
Site 1004
Louisville, Kentucky, United States Recruiting -
Site 1005
Houston, Texas, United States Recruiting -
Site 1002
Fairfax, Virginia, United States Recruiting -
Site 1203
Edegem, Belgium Recruiting
Show 32 more locations
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Site 1201
Namur, Belgium Recruiting -
Site 1402
Nice, France Recruiting -
Site 1404
Paris, France Recruiting -
Site 1403
Suresnes, France Recruiting -
Site 1601
Kalocsa, Hungary Recruiting -
Site 1705
Candiolo, Italy Recruiting -
Site 1703
Meldola, Italy Recruiting -
Site 1702
Ravenna, Italy Recruiting -
Site 1802
Otwock, Poland Recruiting -
Site 1804
Poznan, Poland Recruiting -
Site 1801
Przemyśl, Poland Recruiting -
Site 1904
Bucharest, Romania Recruiting -
Site 1903
Cluj-Napoca, Romania Recruiting -
Site 1901
Craiova, Romania Recruiting -
Site 2013
Badajoz, Spain Recruiting -
Site 2012
Badalona, Spain Recruiting -
Site 2014
Barcelona, Spain Recruiting -
Site 2003
Barcelona, Spain Recruiting -
Site 2006
Barcelona, Spain Recruiting -
Site 2001
Barcelona, Spain Recruiting -
Site 2007
Girona, Spain Recruiting -
Site 2002
Madrid, Spain Recruiting -
Site 2005
Madrid, Spain Recruiting -
Site 2019
Madrid, Spain Recruiting -
Site 2004
Madrid, Spain Recruiting -
Site 2011
Madrid, Spain Recruiting -
Site 2010
Manresa, Spain Recruiting -
Site 2008
Seville, Spain Recruiting -
Site 2009
Valencia, Spain Recruiting -
Site 2015
Valencia, Spain Recruiting -
Site 2203
Edinburgh, United Kingdom Recruiting -
Site 2201
London, United Kingdom Recruiting
Study contacts
- Study coordinator: MediLink Study Team
- Email: clinicaltrials@medilinkthera.com
- Phone: 86 0512-62858368
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.