A Phase III Study of YL201 in Relapsed Small Cell Lung Cancer

NCT06612151 | Recruiting Phase 3

• 1 other identifier: YL201-CN-302-01
• Study Type: interventional
• Target: 438
• Locations: 1 country
• Sites: 1

Brief Summary

This study was designed to compare the efficacy and safety of YL201 with Topotecan Hydrochloride in subjects with relapsed small cell lung cancer (SCLC).

Conditions

Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• To compare the OS of YL201 versus topotecan hydrochloride in subjects with relapsed SCLC.

  (OS) defined as the time interval from the first randomization to death due to any cause.

  Approximately within 36 months

Secondary Outcomes (15)

• To compare Investigator-assessed progression-free survival (PFS) of YL201 versus topotecan hydrochloride in subjects with relapsed SCLC.

  Approximately within 36 months

• To compare Investigator-assessed objective response rate (ORR) of YL201 versus topotecan hydrochloride in subjects with relapsed SCLC.

  Approximately within 36 months

• To compare duration of response (DoR) as assessed by the investigator of YL201 versus topotecan hydrochloride in subjects with relapsed SCLC.

  Approximately within 36 months

• To compare time to response (TTR) as assessed by the investigator of YL201 versus topotecan hydrochloride in subjects with relapsed SCLC.

  Approximately within 36 months

• To compare disease control rate (DCR) assessed by the investigator of YL201 versus topotecan hydrochloride in subjects with relapsed SCLC.

  Approximately within 36 months

Study Arms (2)

YL201

EXPERIMENTAL

Participants are randomized to receive YL201 monotherapy intravenously on Day 1 of each 3-week cycle at RP3D dose level, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent as specified in the protocol.

Drug: YL201

topotecan hydrochloride for injection

ACTIVE COMPARATOR

Participants are randomized to receive topotecan hydrochloride intravenously, on Days 1 to 5 of each 3-week cycle per prescribing information, until PD, unacceptable toxicity, or withdrawal of consent as specified in the protocol.

Drug: topotecan hydrochloride for injection

Interventions

YL201 DRUG

Patients will be treated with YL201 intravenous (IV) infusion once every 3 weeks (Q3W) as a cycle at RP3D dose level.

YL201

topotecan hydrochloride for injection DRUG

Topotecan hydrochloride will be administered intravenously per prescribing information.

topotecan hydrochloride for injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign and date the informed consent form prior to the start of any study-specific qualification procedures.
• Aged ≥18 and ≤75 years, male or female.
• ECOG PS 0 or 1.
• Life expectancy ≥ 3 months.
• Histologically or cytologically confirmed SCLC. Subjects with combined SCLC or any transformed SCLC are not eligible.
• Has limited-stage or extensive-stage disease at study entry, with progression on or after first-line platinum-based therapy (at least 2 cycles).
• At least one measurable lesion according to RECIST version 1.1.
• Subjects are willing to provide tumor tissue (freshly obtained or archived) for detection of B7-H3 expression.
• Adequate organ function.

You may not qualify if:

• History of other malignant tumors within 5 years prior to the first dose of study drug. Subjects cured by radical treatment are not included, such as basal cell carcinoma, squamous cell carcinoma of skin, superficial bladder cancer, carcinoma in situ of the cervix, or breast cancer in situ.
• Previously received B7-H3-targeted therapy, including antibody, antibody-drug conjugate (ADC), and chimeric antigen receptor T cell (CAR-T).
• Previously received treatment with a topoisomerase I inhibitor or an ADC consisting of a topoisomerase I inhibitor.
• Inadequate washout period for prior anti-tumor treatment before the first dose of study drug.
• Received systemic steroids or other immunosuppressive therapy within 2 weeks before the first dose of study drug.
• Received any live vaccine within 4 weeks before the first dose of study drug or intend to receive a live vaccine during the study.
• Presence of brain stem or meningeal metastases, spinal cord metastases or compression.
• Presence of central nervous system (CNS) metastasis. Participants with treated brain metastases are eligible if the metastases are asymptomatic and stable, and no immediate local or systemic treatment is needed within 2 weeks before the first dose.
• Presence of pleural effusion, pericardial effusion, or ascites with clinical symptoms or requiring repeated drainage.
• Has an uncontrolled concurrent disease.
• Presence of severe uncontrolled cardiovascular disorder.
• History of interstitial lung disease (ILD) or pneumonitis that required corticosteroids, or current ILD/pneumonitis
• Concomitant pulmonary disorder leading to clinically severe respiratory impairment.
• Chronic autoimmune or inflammatory diseases requiring or receiving systemic therapy within 2 years prior to the first dose.
• Serious infections within 4 weeks prior to the first dose.

Sponsors & Collaborators

• MediLink Therapeutics (Suzhou) Co., Ltd.: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Topotecan; Injections

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Xianfeng Zhu

CONTACT

+86 512 6285 8368; xianfeng.zhu@medilinkthera.com

Xian Zhang

CONTACT

+86 512 6285 8368; zhangxian@medilinkthera.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: September 25, 2024
• Study Start: December 17, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2030
• Last Updated: February 11, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)