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UNKNOWNPHASE1/PHASE2

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

NCT05745740•RemeGen Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

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.

Locations (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

April 1, 2024

Primary Completion Date

December 1, 2025

Completion Date

December 1, 2025

Last Updated

November 27, 2023

Enrollment

ESTIMATED participants

Conditions

Non-small Cell Lung Cancer

Interventions

RC48-ADC

DRUG

Pyrotinib

DRUG

Contacts

Jianmin Fang, Ph.D

CONTACT

+8610-58075763 jianminfang@hotmail.com

Na Su

CONTACT

+8610-58075763 na.su@remegen.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 27, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)

Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment

Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations

Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)