NCT04063462 is a Phase 2 clinical trial of Pyrotinib in Non Small Cell Lung Cancer, sponsored by Tianjin Medical University Cancer Institute and Hospital.

Who is sponsoring NCT04063462?

NCT04063462 is sponsored by Tianjin Medical University Cancer Institute and Hospital.

What drugs are being tested in NCT04063462?

Interventions in NCT04063462: Pyrotinib.

What condition does NCT04063462 study?

NCT04063462 studies Non Small Cell Lung Cancer.

Is NCT04063462 still recruiting?

NCT04063462 is currently status unknown. Last updated 21 August 2019.

Last reviewed 2019-08-21 · How we verify

NCT04063462

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

Phase 2 Study of Pyrotinib in Previously Treated Patients With NSCLC Having EGFR or ERBB2 Exon 20 Insertion Mutation

Status unknown Phase 2 Last updated 21 August 2019

What this trial tests

Phase 2 trial testing Pyrotinib in Non Small Cell Lung Cancer in 60 participants. Status unknown.

Timeline

1 October 2019

Primary endpoint
1 April 2021

1 October 2021

Quick facts

Lead sponsor	Tianjin Medical University Cancer Institute and Hospital
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	1 October 2019
Primary completion	1 April 2021
Estimated completion	1 October 2021
Sites	1 location across China

Drugs / interventions tested

Pyrotinib — full drug profile →

Conditions studied

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

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Who can join

Adults 18 to 80, any sex, with Non Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase 2, open-label study to evaluate the efficacy and the safety/tolerability of pyrotinib in previously treated NSCLC patients with EGFR exon 20 insertion mutations or HER2 exon 20 insertion mutations. Patient has had at least one prior systemic treatment for locally advanced or metastatic NSCLC.

Publications & conference data

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

HER2 in Non-Small Cell Lung Cancer: A Review of Emerging Therapies.
Uy NF, Merkhofer CM, Baik CS. · · 2022 · cited 48× · PMID 36077691 · DOI 10.3390/cancers14174155
Predictive and Prognostic Biomarkers for Lung Cancer Bone Metastasis and Their Therapeutic Value.
Chai X, Yinwang E, Wang Z, Wang Z, et al · · 2021 · cited 36× · PMID 34722241 · DOI 10.3389/fonc.2021.692788
Molecular pathways, resistance mechanisms and targeted interventions in non-small-cell lung cancer.
Wang Z, Xing Y, Li B, Li X, et al · · 2022 · cited 31× · PMID 36508072 · DOI 10.1186/s43556-022-00107-x
Non-small Cell Lung Cancer with EGFR or HER2 Exon 20 Insertion Mutations: Diagnosis and Treatment Options.
Brazel D, Kroening G, Nagasaka M. · · 2022 · cited 22× · PMID 36255589 · DOI 10.1007/s40259-022-00556-4
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
Molecular landscape of ERBB2 alterations in 3000 advanced NSCLC patients.
Hong L, Patel S, Drusbosky LM, Xiong Y, et al · · 2024 · cited 19× · PMID 39354054 · DOI 10.1038/s41698-024-00720-9
[Advances in Treatment of Non-small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations].
Yang X, Zhao J. · · 2022 · cited 3× · PMID 35599009 · DOI 10.3779/j.issn.1009-3419.2022.103.01

Verify or expand the search:

Other trials of Pyrotinib

Trials testing the same drug.

NCT06495541 — The Real World Study of Pyrotinib in the Treatment of Advanced Breast Cancer With HER2 Positive · NA · not yet recruiting
NCT07470203 — Pyrotinib Combined With Trastuzumab and Pertuzumab for Maintenance Therapy in HER2-Positive Advanced Breast Cancer · not yet recruiting
NCT07417241 — SHR-A1811 vs Pyrotinib/Capecitabine in Trastuzumab-Resistant HER2+ Advanced Breast Cancer: A Randomized Study · Phase 2 · not yet recruiting
NCT07340398 — Neoadjuvant Trastuzumab-rezetecan Plus Pertuzumab or Nab-Paclitaxel, Carboplatin, Trastuzumab, and Pyrotinib After Subop · Phase 2 · recruiting
NCT07179939 — Maintenance Therapy in HER2-Positive Unresectable Locally Recurrent or Metastatic Breast Cancer: A Phase II Study · 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 Tianjin Medical University Cancer Institute and Hospital trials

Trials by the same sponsor.

NCT07493993 — Clinical Study on the Efficacy and Safety of Iparomlimab and Tuvonralimab Injection Combined With Nab-Paclitaxel in Neoa · Phase 2 · not yet recruiting
NCT07515469 — A Prospective, Single-Arm, Exploratory Study of the Safety and Efficacy of Neoadjuvant Treatment With QL1706, an Anti-PD · Phase 2 · not yet recruiting
NCT07475026 — A Study of Neoadjuvant Tislelizumab Plus Lenvatinib in Resectable HCC at High Risk of Recurrence · Phase 3 · not yet recruiting
NCT07510594 — A Phase II Study of Benmelstobart + Anlotinib + Chemotherapy as First-Line Treatment for LCNEC and EP-NEC · Phase 2 · not yet recruiting
NCT07528274 — Microwave Ablation Plus Tislelizumab and Docetaxel in Advanced NSCLC After First-Line Immunotherapy Failure · Phase 2 · 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 NCT04063462 (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 Tianjin Medical University Cancer Institute and Hospital
Last refreshed: 21 August 2019

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/NCT04063462.

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