Pivotal study to evaluate YL202 versus Docetaxel in Patients with Locally Advanced or Metastatic EGFR Sensitive Mutation Non-Squamous Non-Small Cell Lung Cancer

A Multicenter, Randomized, Open-label, Phase III Study to Compare the Efficacy and Safety of YL202 and Docetaxel in Patients with Locally Advanced or Metastatic EGFR Sensitive Mutation Non-Squamous Non-Small Cell Lung Cancer

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600120457

Enrollment

Unknown

Registered

2026-03-16

Start date

2026-03-17

Completion date

Unknown

Last updated

2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small cell lung cancer

Interventions

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

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

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Sign the informed consent form voluntarily and understand the protocol requirements. 2.Age>=18 to = 9.0 g/dL; Absolute Neutrophil Count (ANC) >=1.5 × 10^9/L; Platelet Count (PLT) = 100 × 10^9/L; Alanine Aminotransferas

Exclusion criteria

Exclusion criteria: 1.Histologically or cytologically confirmed concomitant small cell lung cancer, neuroendocrine carcinoma, carcinosarcoma, or squamous cell carcinoma component exceeding 10%. 2.Previous treatment with HER3-targeted therapies (including antibodies, antibody-drug conjugates [ADCs], chimeric antigen receptor T-cell [CAR-T] therapy, and other agents). 3.Previous treatment with docetaxel in the locally advanced or metastatic disease setting. 4.Previous use of topoisomerase I inhibitors or ADCs containing topoisomerase I inhibitors. 5.Concurrent participation in another clinical trial, unless it is an observational (non-interventional) clinical trial or in the follow-up phase of an interventional study. 6.Insufficient washout period from prior anti-tumor therapy, defined as follows: Small-molecule targeted therapy: 20 mg/day prednisone or equivalent) or other immunosuppressive therapy within 2 weeks prior to randomization, excluding the following: Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra-articular injections); Physiologic doses of systemic steroids for replacement therapy (e.g., physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency); Steroids used as preventi

Design outcomes

Primary

Measure	Time frame
Progression-free survival period ;overall survival;	—

Secondary

Measure	Time frame
Duration of response;Disease control rate;Time to response;	—

Countries

China

Contacts

Public ContactCaicun Zhou

Shanghai Dongfang Hospital

caicunzhoudr@163.com+86 21 5882 2171

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 3, 2026