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Research on the Mechanism of Resistance to Antibody-drug conjugates in HER2-Mutant Non-Small Cell Lung Cancer Patients and Sequential Treatment Plans Based on NGS Detection and Organoid Models

Research on the Mechanism of Resistance to Antibody-drug conjugates in HER2-Mutant Non-Small Cell Lung Cancer Patients and Sequential Treatment Plans Based on NGS Detection and Organoid Models

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600125580
Enrollment
Unknown
Registered
2026-05-28
Start date
2026-05-28
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

NSCLC

Interventions

HER2-mutant NSCLC:None

Sponsors

Beijing Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients with unresectable or radiotherapy-resistant stage IIIB/IIIC or metastatic NSCLC confirmed by histology or cytology (using the 8th edition AJCC); 2. Disease progression after treatment with antibody-drug conjugates; 3. Sufficient post-progression tumor tissue samples must be provided at enrollment for NGS gene testing; 4. Able to understand and agree to comply with the study requirements and assessment schedule, and sign the informed consent form; 5. Aged 18 years or older at the time of signing the ICF.

Exclusion criteria

Exclusion criteria: 1. Patients who are unable to undergo tissue biopsy or for whom the tissue biopsy specimen is insufficient for NGS testing; 2. Patients with an ECOG score greater than 2, whom the investigator assesses to be unable to receive sequential anti-tumor therapy; 3. Patients who have not previously received antibody-drug conjugate therapy; 4. At the time of enrollment, all prior treatment-related toxicities (except for hair loss) must be grade 2 or lower; 5. Patients who received prior systemic anti-cancer treatment (chemotherapy, radiotherapy, biological therapy, vaccine therapy, or experimental treatment) within the last 2 weeks before the first administration of combination therapy, and received immune checkpoint inhibitor treatment within 4 weeks; 6. Any other underlying medical conditions that may be detrimental to, or potentially affect the interpretation of results, or that may place the patient at high risk of treatment-related complications, or reasons deemed by the investigator as unsuitable for enrollment.

Design outcomes

Primary

MeasureTime frame
Molecular characteristics of NGS gene testing before and after treatment;

Secondary

MeasureTime frame
Progression-free survival, PFS;

Countries

China

Contacts

Public ContactBo Jia

Beijing Cancer Hospital

jiabo1987@sina.com+86 10 8819 6456

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026