Pivotal Study to Evaluate YL202 Versus Docetaxel in Patients With Locally Advanced or Metastatic EGFR Sensitive Mutation Non-Squamous Non-Small Cell Lung Cancer

NCT07416994 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: YL202-CN-301-01
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 2

Brief Summary

Non-small cell lung cancer (NSCLC) is a common type of lung cancer where abnormal cells in the lungs grow out of control. The purpose of this study is to evaluate YL202 monotherapy versus Docetaxel in participants with locally advanced or metastatic non-squamous NSCLC with EGFR mutation who have failed to EGFR-TKI therapy and platinum-based chemotherapy.

Conditions

Non-Small Cell Lung Cancer

Keywords

Non-Small Cell Lung Cancer; EGFR-Mutated

Outcome Measures

Primary Outcomes (2)

• Overall Survival (OS)

  OS is defined as the time from randomization to the event of death from any cause.

  Up to Approximately 36 Months

• Title: Progression-Free Survival (PFS) assessed by Blinded Independent Central Review (BICR)

  PFS is defined as the time from randomization to the first occurrence of radiographic progression based on RECIST version 1.1 as determined by BICR or death from any cause, whichever occurs earlier.

  Up to Approximately 36 Months

Secondary Outcomes (3)

• Progression-Free Survival assessed by Investigator

  Up to Approximately 36 Months

• Overall response rate（ORR）assessed by BICR

  Up to Approximately 36 Months

• Characterize Pharmacokinetics parameter Ctrouph trough concentration

  Up to Approximately 12 Months

Study Arms (2)

YL202

EXPERIMENTAL

Drug: YL202

Docetaxel

ACTIVE COMPARATOR

Drug: Docetaxel

Interventions

YL202 DRUG

Participants will receive YL202 at dose 2.0mg/kg by intravenous infusion, on Day 1 of each 3-week cycle;

YL202

Docetaxel DRUG

Participants will receive Docetaxel at dose 75mg/m2 by intravenous infusion, on Day 1 of each 3-week cycle;

Docetaxel

Eligibility Criteria

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

You may qualify if:

• Males or females aged ≥18 to ≤75 years at the time of signing the ICF
• Histologically or cytologically confirmed diagnosis of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with documented EGFR Exon 19 deletion or Exon21 L858R mutation.
• Received one prior epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) therapy in the locally advanced, or metastatic setting, either as monotherapy or in combination with other agents; Received one prior platinum based chemotherapy in the locally advanced, or metastatic setting, either prior to TKI, in combination with TKI, or after TKI therapy.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
• At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, that has not been previously irradiated.
• Central nervous system (CNS) metastasis, these should be clinically asymptomatic or stable after definitive treatment.
• Current, historical, or suspected interstitial lung disease (ILD)/pneumonitis.

You may not qualify if:

• Histologically or cytologically confirmed presence of small cell lung cancer, neuroendocrine carcinoma, and carcinosarcoma components or squamous cell carcinoma components of more than 10%;
• Other malignancies within 5 years prior to the first dose;
• History of (noninfectious) interstitial lung disease (ILD) and current ILD
• Prior HER3-targeted therapy; Prior treatment with any drug therapy targeting topoisomerase I inhibitor, including antibody-drug conjugates (ADCs);
• Pregnant or lactating women;

Sponsors & Collaborators

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

Study Sites (2)

Shanghai Dongfang Hospital

Shanghai, Shanghai Municipality, 200120, China

Location

Zhejiang Provincial Cancer

Hangzhou, Zhejiang, 310022, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Docetaxel

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)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Central Study Contacts

Medilink Study Team

CONTACT

+86 0512-62858368; clinicaltrials@medilinkthera.com

Study Design

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

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 18, 2026
• Study Start: March 6, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

CN (2)