A Study of RC48-ADC Combined With Pyrotinib For Treatment of Local Advanced or Metastasis NSCLC With HER2 Mutation

Trial Title: A Study of RC48-ADC Combined With Pyrotinib For Treatment of Local Advanced or Metastasis NSCLC With HER2 Mutation

NCT ID: NCT05745740

Condition: Non-small Cell Lung Cancer

Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: RC48-ADC
Description: RC48-ADC 1.5/2.0 mg/kg by intravenous (IV) infusion, given on Day 1 of each 14-day cycle
Arm group label: RC48-ADC + Pyrotinib

Other name: DV

Intervention type: Drug
Intervention name: Pyrotinib
Description: Pyrotinib 400 mg by oral once a day.
Arm group label: RC48-ADC + Pyrotinib

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.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: Shanghai Pulmonary Hospital

Address:
City: Shanghai
Zip: 200433
Country: China

Start date: April 2024

Completion date: December 2025

Lead sponsor:
Agency: RemeGen Co., Ltd.
Agency class: Industry

Source: RemeGen Co., Ltd.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05745740