Tests two HER2-targeted drugs together in lung cancer with HER2 mutation
Tests RC48-ADC with pyrotinib in adults with advanced lung cancer carrying HER2 mutations.
Plain-language title generated from the registry record
Registry title: A Study of RC48-ADC Combined With Pyrotinib For Treatment of Local Advanced or Metastasis NSCLC With HER2 Mutation
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with lung cancer (non-small cell) that has spread or cannot be removed by surgery, and that has a HER2 exon 20 insertion mutation.
- Age
- 18 to 80 years
- Sex
- Women and men can join.
- Disease stage
- Non-small cell lung cancer that is locally advanced or has spread, cannot be removed by surgery, and has a lesion that can be measured (RECIST 1.1). Expected survival of at least 12 weeks. ECOG performance status 0 or 1.
- Earlier treatment
- People must have had both platinum-based therapy and immunotherapy, and the cancer came back or did not respond to standard treatment. People who had earlier HER2-targeted therapy cannot join.
- Biomarker or test result
- A documented HER2 exon 20 insertion mutation. No known EGFR, ALK, ROS1, RET, NTRK, MET 14 or BRAF V600E mutation.
Main reasons for not taking part
- Earlier treatment with HER2-targeted therapy
- Hepatitis B, hepatitis C or HIV infection (positive test)
- NYHA Class III heart failure
- Active infection that needs treatment through the whole body
- Uncontrolled high blood pressure, diabetes, interstitial lung disease or COPD
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT05745740, who can take part
Where in China
- Shanghai Pulmonary HospitalShanghai, ChinaContact: Jianmin Fang, Ph.DNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- RemeGen Co., Ltd.
- Trial code
- NCT05745740
- Record updated
- 22 September 2026
- Original description
This study will evaluate the efficacy, safety and pharmacokinetics of RC48-ADC for injection combined with pyrotinib in subjects with local advanced or metastatic non-small cell lung cancer with HER2 mutation.Read full original descriptionShow less
An Open-label, Single-center, Phase Ib/II Study to Evaluate the Safety, Efficacy and Pharmacokinetics of RC48-ADC Combined With Pyrotinib in Local Advanced or Metastasis NSCLC With HER2 Mutation
This study will evaluate the efficacy, safety and pharmacokinetics of RC48-ADC for injection combined with pyrotinib in subjects with local advanced or metastatic non-small cell lung cancer with HER2 mutation.
Inclusion: Voluntary agreement to provide written informed consent; Predicted survival ≥ 12 weeks; According to UICC/AJCC 8th Edition, histologically and/or cytologically-confirmed, cannot be surgically removed, locally advanced or metastatic NSCLC; Is willing and able to provide an adequate archival tumor tissue sample; Has relapsed from or is refractory to standard treatment and had received both platinum-based therapy and immunotherapy; Measurable lesion according to RECIST 1.1; Documented HER2 exon 20 insertion mutation; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; Adequate organ function; For female subjects: should be surgically sterilized, postmenopausal, or agree to use a medically approved contraceptive (such as an intrauterine device, contraceptives, or condoms) during study treatment and within 6 months after the end of study, the blood pregnancy test within 7 days of study enrollment must be negative and must be non-lactating. Male subjects: Patients who should be surgically sterilized or agree to use a medically approved contraceptive during the study treatment period and within 6 months after the end of the study; Willing and able to follow trial and follow-up procedures.
Exclusion: Patient has had previous treatment with HER2-targeted therapy prior to study participation; Has received a live virus vaccine within 4 weeks of planned start of trial treatment; Treated with systemic treatment (e.g. immunomodulators, corticosteroids or immunosuppressants) for the autoimmune disease within 2 years prior to the study treatment; History of major surgery within 4 weeks of planned start of trial treatment; Diagnosed with HBsAg, HBcAb positive and HBV DNA copy positive, or HCVAb positive, or HIVAb positive; NYHA Class III heart failure; Suffering from active infection requiring systemic treatment; Uncontrolled hypertension, diabetes, Interstitial lung Disease, or COPD; No known EGFR, ALK, ROS1, RET, NTRK, MET 14 or BRAF V600E mutation.