YL201 + Atezolizumab for Small Cell Lung Cancer

MS
Overseen ByMediLink Study Team
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

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.12345

Why 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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Part 1: Dose escalation to determine safety and tolerability of YL201 in combination with atezolizumab

Varies until dose determination

Dose Optimization

Part 2: Dose optimization stage where participants are randomized to receive different doses of YL201 with atezolizumab

Varies based on dose optimization

Dose Expansion

Continuation of treatment with selected dose(s) based on safety, PK, and efficacy review

Until disease progression or unacceptable toxicity

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 6 years

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

Group I: YL201 2.0mg/kg in combination with atezolizumab 1200mg Q3WExperimental Treatment2 Interventions
Group II: YL201 1.6mg/kg in combination with atezolizumab 1200mg Q3WExperimental Treatment2 Interventions
Group III: YL201 1.2mg/kg in combination with atezolizumab 1200mg Q3WExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

MediLink Therapeutics (Suzhou) Co., Ltd.

Lead Sponsor

Trials
12
Recruited
3,400+

Hoffmann-La Roche

Industry Sponsor

Trials
2,482
Recruited
1,107,000+
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Avastin, Herceptin, Rituxan, Accu-Chek
Dr. Levi Garraway profile image

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker profile image

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Genentech, Inc.

Industry Sponsor

Trials
1,578
Recruited
569,000+
Ashley Magargee profile image

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway profile image

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

Citations

Immunotherapy 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.

Integrating 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 ...

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 ...

9.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39830746/

Long-term survival after combination therapy with ...

This case report suggests the potential efficacy and safety of integrating chemotherapy, immunotherapy, radiotherapy, and antiangiogenic ...