NCT04311034 is a Phase 1, PHASE2 clinical trial of RC48 in Non Small Cell Lung Cancer, sponsored by RemeGen Co., Ltd..

Who is sponsoring NCT04311034?

NCT04311034 is sponsored by RemeGen Co., Ltd..

What drugs are being tested in NCT04311034?

Interventions in NCT04311034: RC48.

What condition does NCT04311034 study?

NCT04311034 studies Non Small Cell Lung Cancer.

Is NCT04311034 still recruiting?

NCT04311034 is currently completed. Last updated 18 December 2023.

Last reviewed 2023-12-18 · How we verify

NCT04311034

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of RC48-ADC in Subjects With Advanced Non-small Cell Lung Cancer

Completed Phase 1, PHASE2 Last updated 18 December 2023

What this trial tests

Phase 1, PHASE2 trial testing RC48 in Non Small Cell Lung Cancer in 37 participants. Completed in 30 May 2022.

Timeline

26 September 2018

Primary endpoint
21 December 2021

30 May 2022

Quick facts

Lead sponsor	RemeGen Co., Ltd.
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	37
Start date	26 September 2018
Primary completion	21 December 2021
Estimated completion	30 May 2022
Sites	1 location across China

Drugs / interventions tested

RC48 — full drug profile →

Conditions studied

Non Small Cell Lung Cancer — all drugs for Non Small Cell Lung Cancer →

Sponsor

RemeGen Co., Ltd. — full company profile →

Who can join

Adults 18 to 75, any sex, with Non Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will evaluate the efficacy and safety of RC48-ADC for injection in subjects with advanced non-small cell lung cancer with HER2 overexpression or HER2 mutation.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Implementing antibody-drug conjugates (ADCs) in HER2-positive breast cancer: state of the art and future directions.
Ferraro E, Drago JZ, Modi S. · · 2021 · cited 164× · PMID 34380530 · DOI 10.1186/s13058-021-01459-y
Targeting cancer with antibody-drug conjugates: Promises and challenges.
Dean AQ, Luo S, Twomey JD, Zhang B. · · 2021 · cited 145× · PMID 34291723 · DOI 10.1080/19420862.2021.1951427
Consensus for HER2 alterations testing in non-small-cell lung cancer.
Ren S, Wang J, Ying J, Mitsudomi T, et al · · 2022 · cited 89× · PMID 35149428 · DOI 10.1016/j.esmoop.2022.100395
HER2-targeted therapies in cancer: a systematic review.
Zhu K, Yang X, Tai H, Zhong X, et al · · 2024 · cited 83× · PMID 38308374 · DOI 10.1186/s40364-024-00565-1
HER2-directed antibodies, affibodies and nanobodies as drug-delivery vehicles in breast cancer with a specific focus on radioimmunotherapy and radioimmunoimaging.
Altunay B, Morgenroth A, Beheshti M, Vogg A, et al · · 2021 · cited 74× · PMID 33179151 · DOI 10.1007/s00259-020-05094-1
Novel ADCs and Strategies to Overcome Resistance to Anti-HER2 ADCs.
Díaz-Rodríguez E, Gandullo-Sánchez L, Ocaña A, Pandiella A. · · 2021 · cited 65× · PMID 35008318 · DOI 10.3390/cancers14010154
Targeting HER2 genomic alterations in non-small cell lung cancer.
Zeng J, Ma W, Young RB, Li T. · · 2021 · cited 20× · PMID 39035769 · DOI 10.1016/j.jncc.2021.04.001
The History and Development of HER2 Inhibitors.
Xia X, Gong C, Zhang Y, Xiong H. · · 2023 · cited 16× · PMID 37895921 · DOI 10.3390/ph16101450

Verify or expand the search:

Other trials of RC48

Trials testing the same drug.

NCT07474324 — Disitamab Vedotin Combined With SOX Regimen Versus SOX Alone as Adjuvant Therapy for HER2-Moderate/High Expressing Stage · Phase 2 · recruiting
NCT07172217 — The Efficacy and Safety RC48 Plus QL1706 in Second-Line Treatment of HER2-Expressing Recurrent CC · Phase 2 · not yet recruiting
NCT06663007 — RC48 Monotherapy or Combination With Envafolimab for CDK12 Alterations mCRPC With Standard Treatment Failure · Phase 1, PHASE2 · recruiting
NCT06561555 — A Study on the Efficacy of Disitamab Vedotin in Advanced HER2-positive Paget's Disease. · Phase 2 · recruiting
NCT06385873 — RC48 Combined With Adebrelimab, Apatinib and S-1 as Neoadjuvant Therapy in Locally Advanced Gastric Cancer · Phase 2 · not yet recruiting

Other recruiting trials for Non Small Cell Lung Cancer

Currently open trials in the same condition.

NCT06951646 — ctDNA-MRD Guided Escalation of Ivonescimab and Docetaxel in Advanced NSCLC With Long-Term Responses to First-line Immuno · Phase 2 · recruiting
NCT07503808 — A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Types · Phase 1 · recruiting
NCT07269782 — A Phase II Study to Evaluate the Efficacy and Safety of HLX43 + Serplulimab as Neoadjuvant Therapy in Subjects With NSCL · Phase 2 · recruiting
NCT07306624 — Nelmastobart in Combination With Docetaxel in Non Small Cell Lung Cancer · Phase 2 · recruiting
NCT07323732 — A Study of BIO 300 and Thoracic Radiation Therapy in People With Non-Small Cell Lung Cancer and Interstitial Lung Diseas · Phase 2 · recruiting

Other RemeGen Co., Ltd. trials

Trials by the same sponsor.

NCT07537881 — A I/II Phase Clinical Study to Evaluate the Safety and Efficacy of RC288 in the Treatment of Solid Tumors · Phase 1, PHASE2 · not yet recruiting
NCT07462143 — A Phase Ⅱ/Ⅲ Clinical Trial of RC148 Plus Chemotherapy as 1L Therapy for Unresectable or Metastatic Colorectal Cancer · Phase 2, PHASE3 · not yet recruiting
NCT07495033 — Phase III Clinical Trial of Telitacicept Injection in the Treatment of Patients With Connective Tissue Disease-related I · Phase 3 · not yet recruiting
NCT07416474 — RC148 Plus Platinum-Based Chemotherapy vs Tislelizumab Plus Platinum-Based Chemotherapy for First-Line Squamous Non-Smal · Phase 3 · not yet recruiting
NCT07249632 — A Study of Telitacicept in Patients With Ocular Myasthenia Gravis (OMG) · Phase 3 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04311034 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by RemeGen Co., Ltd.
Last refreshed: 18 December 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04311034.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing