YL201 + Atezolizumab for Small Cell Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new combination of treatments for individuals with extensive-stage small cell lung cancer (ES-SCLC) who have not received prior treatment. The researchers aim to assess the safety and effectiveness of the experimental drug YL201 when combined with atezolizumab, a medication that aids the immune system in fighting cancer. Participants will receive varying doses of YL201 to determine the optimal amount to use alongside atezolizumab. Ideal candidates are those diagnosed with ES-SCLC who have not yet undergone any systemic treatment for their condition. As a Phase 1, Phase 2 trial, this research seeks to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research is testing the safety of combining YL201 with atezolizumab for patients with extensive-stage small cell lung cancer (ES-SCLC). Previous studies have examined how well patients could tolerate this combination. Atezolizumab is already approved for some cancers, providing some safety information about it.
For YL201, researchers are still collecting safety data. The study is testing different doses of YL201 (1.2 mg/kg, 1.6 mg/kg, 2.0 mg/kg) to determine the safest and most effective amount. Since these tests are in the early stages, the primary goal is to ensure the treatment does not cause serious side effects. Identifying any potential negative reactions is crucial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of YL201 and atezolizumab for small cell lung cancer because it introduces a potentially novel approach compared to standard treatments. YL201 is being tested in various doses to determine the most effective combination with atezolizumab, an existing immunotherapy. This combination aims to enhance the immune system's ability to fight cancer cells more effectively. Unlike traditional chemotherapy, which directly kills fast-growing cells, this approach helps the body's own defenses target and destroy cancer cells, potentially improving outcomes and reducing side effects.
What evidence suggests that this trial's treatments could be effective for small cell lung cancer?
Research has shown that atezolizumab, when used as the initial treatment, is effective and safe for patients with extensive-stage small cell lung cancer (ES-SCLC). Atezolizumab, a type of immunotherapy, enhances the body's immune response against cancer cells. In this trial, participants will receive varying dosages of YL201 combined with atezolizumab to assess whether YL201 can boost the effectiveness of atezolizumab. Early results suggest that the combination of YL201 and atezolizumab might be more effective than either treatment alone, but further research is needed to confirm this. These treatments aim to strengthen the body's natural ability to combat cancer.26789
Are You a Good Fit for This Trial?
Adults with a confirmed diagnosis of ES-SCLC who are in good physical condition and have proper organ function can join this trial. It's not for those who've had previous treatments for their lung cancer or have health issues that could interfere with the study.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Part 1: Dose escalation to determine safety and tolerability of YL201 in combination with atezolizumab
Dose Optimization
Part 2: Dose optimization stage where participants are randomized to receive different doses of YL201 with atezolizumab
Dose Expansion
Continuation of treatment with selected dose(s) based on safety, PK, and efficacy review
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Atezolizumab
- YL201
Trial Overview
The trial is testing YL201 at different doses combined with Atezolizumab to find the safest and most effective amount. Participants will be randomly assigned to receive one of three YL201 dose levels along with Atezolizumab until they experience disease progression, side effects, or choose to leave the study.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
MediLink Therapeutics (Suzhou) Co., Ltd.
Lead Sponsor
Hoffmann-La Roche
Industry Sponsor
Dr. Levi Garraway
Hoffmann-La Roche
Chief Medical Officer since 2019
MD from the University of Basel
Dr. Thomas Schinecker
Hoffmann-La Roche
Chief Executive Officer since 2023
PhD in Molecular Biology from New York University
Genentech, Inc.
Industry Sponsor
Ashley Magargee
Genentech, Inc.
Chief Executive Officer since 2024
MBA from Harvard University, BA from Princeton University
Levi Garraway
Genentech, Inc.
Chief Medical Officer since 2021
MD, PhD
Citations
1.
oncologynewscentral.com
oncologynewscentral.com/sclc/immunotherapy-combo-fails-to-improve-survival-in-limited-stage-small-cell-lung-cancerImmunotherapy Combo Fails to Improve Survival in Limited ...
Adding atezolizumab to concurrent chemoradiation did not improve survival for patients with limited-stage small cell lung cancer, ...
YL201 + Atezolizumab for Small Cell Lung Cancer
Atezolizumab; YL201. Trial Overview. The trial is testing YL201 at different doses combined with Atezolizumab to find the safest and most effective amount.
Extended Follow‐Up Analysis of First‐Line Atezolizumab in ...
This study outlined the real‐world effectiveness and safety of first‐line atezolizumab immunochemotherapy for ES‐SCLC patients over an extended ...
Clinical Trials Using Atezolizumab - NCI
Clinical Trials Using Atezolizumab · Comparing Impact of Treatment Before or After Surgery in Patients with Stage II-IIIB Resectable Non-small Cell Lung Cancer.
5.
asset.researchtopractice.com
asset.researchtopractice.com/2025/Webinar/AON/AON25_01_02_Lung_Nov8.pdfIntegrating New Advances into the Care of Patients with ...
“On October 2, 2025, the Food and Drug Administration approved lurbinectedin in combination with atezolizumab or atezolizumab and hyaluronidase- ...
A Study of YL201 in Combination With Other Anti-Cancer ...
Part 1 of the study is a dose escalation in participants with previously untreated ES-SCLC to determine the safety and tolerability of YL201 in ...
7.
theglobeandmail.com
theglobeandmail.com/investing/markets/stocks/AMGN/pressreleases/35744763/amgens-latest-clinical-study-update-a-new-hope-for-small-cell-lung-cancer/Amgen's Latest Clinical Study Update: A New Hope for ...
' The study aims to assess the safety and tolerability of the drug combination in treating extensive stage small cell lung cancer (SCLC), a ...
MediLink Announces Global Clinical Trial Collaboration ...
MediLink has announced the data of a Phase I/II clinical trial of YL201 in patients with advanced solid tumors including SCLC as a selected oral ...
Long-term survival after combination therapy with ...
This case report suggests the potential efficacy and safety of integrating chemotherapy, immunotherapy, radiotherapy, and antiangiogenic ...
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