NCT04535557 is a clinical trial of Mobocertinib 160 mg in Carcinoma, Non-Small-Cell Lung, sponsored by Millennium Pharmaceuticals, Inc..

Who is sponsoring NCT04535557?

NCT04535557 is sponsored by Millennium Pharmaceuticals, Inc..

What drugs are being tested in NCT04535557?

Interventions in NCT04535557: Mobocertinib 160 mg.

What condition does NCT04535557 study?

NCT04535557 studies Carcinoma, Non-Small-Cell Lung.

Is NCT04535557 still recruiting?

NCT04535557 is currently approved for marketing. Last updated 30 September 2022.

Last reviewed 2022-09-30 · How we verify

NCT04535557

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

An Expanded Access Protocol for Mobocertinib in Refractory Non-small Cell Lung Cancer (NSCLC) Participants With Epidermal Growth Factor Receptor (EGFR) Exon20 Insertion Mutations

APPROVED FOR MARKETING Last updated 30 September 2022

What this trial tests

trial testing Mobocertinib 160 mg in Carcinoma, Non-Small-Cell Lung. Approved for marketing.

Quick facts

Lead sponsor	Millennium Pharmaceuticals, Inc.
Status	APPROVED FOR MARKETING
Study type	EXPANDED_ACCESS

Drugs / interventions tested

Mobocertinib 160 mg — full drug profile →

Conditions studied

Carcinoma, Non-Small-Cell Lung — all drugs for Carcinoma, Non-Small-Cell Lung →

Sponsor

Millennium Pharmaceuticals, Inc. — full company profile →

Who can join

18 and older, any sex, with Carcinoma, Non-Small-Cell Lung. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to provide expanded compassionate use access to mobocertinib, in participants with locally advanced or metastatic NSCLC harboring EGFR in-frame exon 20 insertion mutations and who have received at least 1 prior line of therapy for locally advanced or metastatic disease.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Discovery, Development, Inventions, and Patent Trends on Mobocertinib Succinate: The First-in-Class Oral Treatment for NSCLC with EGFR Exon 20 Insertions.
Imran M, Khan SA, Alshammari MK, Alreshidi MA, et al · · 2021 · cited 17× · PMID 34944754 · DOI 10.3390/biomedicines9121938

Verify or expand the search:

Other recruiting trials for Carcinoma, Non-Small-Cell Lung

Currently open trials in the same condition.

NCT07227025 — A Study of Amivantamab and Olomorasib Combination Therapy in Participants With Metastatic Non-Small Cell Lung Cancer · Phase 1, PHASE2 · recruiting
NCT07222566 — Symbiotic-Lung-01 : A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adu · Phase 3 · recruiting
NCT07230691 — A Study of Clinical Outcomes in Participants With EGFR Mutated Advanced Non-Small Cell Lung Cancer (NSCLC) in a Real-Wor · recruiting
NCT07509333 — MDT-Based Umbrella Decision Model for Geriatric Lung Cancer Patients · NA · recruiting
NCT07180862 — A Study Evaluating BAT3306 Compared With Keytruda® in NSCLC Cancer Participants · Phase 1 · recruiting

Other Millennium Pharmaceuticals, Inc. trials

Trials by the same sponsor.

NCT03888534 — Intravenous Ixazomib in Pediatric Participants With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL) or Lymphob · Phase 1 · withdrawn
NCT04056468 — A Study to Evaluate Pharmacokinetics (PK) and Safety of Oral Mobocertinib in Participants With Moderate or Severe Hepati · Phase 1 · completed
NCT04454918 — Study to Assess Absolute Bioavailability (ABA) of TAK-906 and to Characterize Mass Balance, Pharmacokinetics (PK), Metab · Phase 1 · completed
NCT04056455 — A Study of Mobocertinib Capsules in People With Severe Kidney Problems and People With Healthy Kidneys · Phase 1 · completed
NCT04091438 — A Study of a Single Intravenous Infusion Dose of TAK-925 in Participants With Idiopathic Hypersomnia · Phase 1 · completed

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 NCT04535557 (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 Millennium Pharmaceuticals, Inc.
Last refreshed: 30 September 2022

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/NCT04535557.

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