Non-small Cell Lung Cancer
Conditions
Brief summary
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.
Interventions
DRUGPyrotinib
Pyrotinib 400 mg by oral once a day.
DRUGRC48-ADC
RC48-ADC 1.5/2.0 mg/kg by intravenous (IV) infusion, given on Day 1 of each 14-day cycle
Sponsors
RemeGen Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* No known EGFR, ALK, ROS1, RET, NTRK, MET 14 or BRAF V600E mutation. * Patient has had previous treatment with HER2-targeted therapy prior to study participation. * 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. * Has received a live virus vaccine within 4 weeks of planned start of trial treatment. * NYHA Class III heart failure. * Suffering from active infection requiring systemic treatment. * Uncontrolled hypertension, diabetes, Interstitial lung Disease, or COPD. * Treated with systemic treatment (e.g. immunomodulators, corticosteroids or immunosuppressants) for the autoimmune disease within 2 years prior to the study treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| maximal tolerance dose (MTD) of RC48-ADC combined with Pyrotinib | DLT will be evaluated on 28 days of observation period | Maximum-tolerated dose (MTD) was defined as the highest dose level at which no more than one of six patients experienced DLT during the DLT assessment window. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate (ORR) | Up to approximately 3 years | The objective response rate will be mainly analyzed by investigators according to the RECIST 1.1 standard tumor evaluation. |
| Disease control rate (DCR) | Up to approximately 3 years | Disease control rate (DCR) is defined as cases where objective remission (assessed as complete remission or partial remission according to RECIST 1.1 standard) or stable disease during the study. |
| Duration of relief (DOR) | Up to approximately 3 years | DOR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death. |
| Progression-free survival (PFS) | Up to approximately 3 years | Progression-free survival (PFS) refers to the time from the date of randomization to the first researcher's evaluation of disease progression or death. |
| Overall survival (OS) | Up to approximately 3 years | The objective response rate will be mainly analyzed by investigators according to the RECIST 1.1 standard tumor evaluation |
Countries
China
Contacts
Primary ContactJianmin Fang, Ph.D
Backup ContactNa Su
Outcome results
None listed