NCT04576208 is a Phase 2 clinical trial of TAK-788 in Non-Small Cell Lung Cancer (NSCLC), sponsored by Takeda.

Who is sponsoring NCT04576208?

NCT04576208 is sponsored by Takeda.

What drugs are being tested in NCT04576208?

Interventions in NCT04576208: TAK-788, Antidiarrheal prophylaxis.

What condition does NCT04576208 study?

NCT04576208 studies Non-Small Cell Lung Cancer (NSCLC).

Is NCT04576208 still recruiting?

NCT04576208 is currently withdrawn. Last updated 17 December 2020.

Last reviewed 2020-12-17 · How we verify

NCT04576208

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

A Study to Evaluate the Impact of Management Strategies on Gastrointestinal-Related Adverse Events in Participants With Non-Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations Receiving TAK-788

Withdrawn Phase 2 Last updated 17 December 2020

What this trial tests

Phase 2 trial testing TAK-788 in Non-Small Cell Lung Cancer (NSCLC). Withdrawn.

Timeline

30 November 2020

Primary endpoint
31 July 2022

31 July 2022

Quick facts

Lead sponsor	Takeda
Phase	Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Start date	30 November 2020
Primary completion	31 July 2022
Estimated completion	31 July 2022

Drugs / interventions tested

TAK-788 — full drug profile →
Antidiarrheal prophylaxis — full drug profile →

Conditions studied

Non-Small Cell Lung Cancer (NSCLC) — all drugs for Non-Small Cell Lung Cancer (NSCLC) →

Sponsor

Takeda — full company profile →

Who can join

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

Sponsor's own description

The purpose of the study is to characterize the incidence and severity of TAK-788-associated diarrhea in previously treated participants with locally advanced or metastatic non-small-cell lung cancer (NSCLC) whose tumors harbor EGFR exon 20 insertion mutations treated with TAK-788 when administered with or without intensive loperamide prophylaxis.

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 trials of TAK-788

Trials testing the same drug.

NCT04441255 — A Study to Evaluate the Effect of High-Fat Meal on TAK-788 Pharmacokinetics (PK) in Healthy Adult Participants · Phase 1 · completed
NCT04129502 — TAK-788 as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon · Phase 3 · active not recruiting
NCT04051827 — Drug-Drug Interaction Study of TAK-788 and Midazolam in Participants With Advanced Non-small Cell Lung Cancer (NSCLC) · Phase 1 · completed
NCT03928327 — A Study to Evaluate Drug-Drug Interaction of TAK-788 With Itraconazole and Rifampin in Healthy Adult Participants · Phase 1 · completed
NCT03482453 — A Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability of TAK-788 Followed by Evaluation of the Effects · Phase 1 · completed

Other recruiting trials for Non-Small Cell Lung Cancer (NSCLC)

Currently open trials in the same condition.

NCT07361510 — A Study to Evaluate the Efficacy of Pumitamig Versus Pembrolizumab in Participants With Previously Untreated Advanced No · Phase 3 · recruiting
NCT07410494 — Biomarker-Guided Allogeneic Single-Target or Dual-Target CAR-NK Cell Therapy for Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
NCT07510724 — Real-World Data on the Treatment of Lung Cancer Patients With the Immune-Checkpoint Inhibitor Tislelizumab · recruiting
NCT06710132 — Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors (PROCEADE PanTumor) · Phase 1, PHASE2 · recruiting
NCT06558799 — LUNAR-4: Effect of Tumor Treating Fields (TTFields) (150 kHz) Concurrent With Pembrolizumab for Treatment of Metastatic · Phase 2 · active not recruiting

Other Takeda trials

Trials by the same sponsor.

NCT05669729 — A Survey to Assess Participants', Caregivers', and Nurses' Use and Understanding of Educational Material on Velagluceras · not yet recruiting
NCT07403968 — A Study of Zasocitinib (TAK-279) in Adults With Active Crohn's Disease · Phase 2 · not yet recruiting
NCT07293364 — A Study to Learn About the C1-Inhibitor Function as Diagnosis for Hereditary Angioedema · NA · not yet recruiting
NCT07218393 — A Study About the Diagnosis and Management of Hereditary Angioedema (HAE) in Egypt · not yet recruiting
NCT07445087 — A Study of Takhzyro in Teenagers and Adults With Hereditary Angioedema (HAE) in South Korea · not yet 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 NCT04576208 (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 Takeda
Last refreshed: 17 December 2020

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/NCT04576208.

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