NCT05745740Not yet recruitingPhase 1/2
A Study of RC48-ADC Combined With Pyrotinib For Treatment of Local Advanced or Metastasis NSCLC With HER2 Mutation
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
Source: ClinicalTrials.gov · Last updated 22 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 26 (estimated)
- First submitted
- 16 Feb 2023
- Start date
- 1 Dec 2027
- Primary completion date
- 1 Dec 2027
- Lead sponsor
- RemeGen Co., Ltd.
- Diseases
- Lung cancer
- NCT number
- NCT05745740
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 26
- From 1 Dec 2027 to the primary completion date, 1 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Lab values
- No known EGFR, ALK, ROS1, RET, NTRK, MET 14 or BRAF V600E mutation.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Pulmonary Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.