NCT06569420 is a Phase 3 clinical trial of Drug: Foritinib Succinate in Non-Small Cell Lung Cancer, sponsored by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd..

Who is sponsoring NCT06569420?

NCT06569420 is sponsored by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd..

What drugs are being tested in NCT06569420?

Interventions in NCT06569420: Drug: Foritinib Succinate, Drug: Crizotinib.

What condition does NCT06569420 study?

NCT06569420 studies Non-Small Cell Lung Cancer, ALK-positive, SAF-189s.

Is NCT06569420 still recruiting?

NCT06569420 is currently active, enrolled. Last updated 26 August 2024.

Last reviewed 2024-08-26 · How we verify

NCT06569420

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

Study Of Comparing SAF-189s With Crizotinib In First Line ALK-Positive Advanced and Metastatic NSCLC

Active, enrolled Phase 3 Last updated 26 August 2024

What this trial tests

Phase 3 trial testing Drug: Foritinib Succinate in Non-Small Cell Lung Cancer in 275 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

31 December 2021

Primary endpoint
31 July 2025

31 December 2027

Quick facts

Lead sponsor	Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	275
Start date	31 December 2021
Primary completion	31 July 2025
Estimated completion	31 December 2027
Sites	1 location across China

Drugs / interventions tested

Drug: Foritinib Succinate
Drug: Crizotinib

Conditions studied

Non-Small Cell Lung Cancer — all drugs for Non-Small Cell Lung Cancer →
ALK-positive — all drugs for ALK-positive →
SAF-189s — all drugs for SAF-189s →

Sponsor

Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. — full company profile →

Who can join

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

Sponsor's own description

This randomized, multicenter, Phase III, open-label study will evaluate the efficacy and safety of SAF-189s versus crizotinib treatment in participants with treatment-naive ALK-positive advanced NSCLC. Participants will be randomized 1:1 into one of the two treatment groups to receive either SAF-189s (160 milligrams \[mg\] once daily \[QD\]) or crizotinib (250 mg BID) orally, respectively.

Publications & conference data

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

Recent advances in the treatment of non-small cell lung cancer with MET inhibitors.
Zhang D, Zhang W, Liu H, Liu P, et al · · 2024 · cited 1× · PMID 39720556 · DOI 10.3389/fchem.2024.1501844

Verify or expand the search:

Other recruiting trials for Non-Small Cell Lung Cancer

Currently open trials in the same condition.

NCT07140315 — DK222 Study at Hopkins · Phase 1 · recruiting
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NCT07460999 — Singing Training vs Usual Care 6-18 Months After Surgical Resection for Non-small Cell Lung Cancer (NSCLC) · NA · recruiting
NCT07479277 — Progel Platinum for Air Leak Reduction After VATS Lobectomy for NSCLC · NA · recruiting

Other Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. trials

Trials by the same sponsor.

NCT07502638 — FXS6837 for the Treatment of IgAN Patients · Phase 2 · not yet recruiting
NCT07345637 — Phase I Study of FXS887 in the Treatment of Solid Tumors · Phase 1 · not yet recruiting
NCT07004075 — FCN-159 Monotherapy Versus Chemotherapy by Investigator's Choice in Pediatric Low-grade Glioma Patients With BRAF Altera · Phase 3 · not yet recruiting
NCT07024394 — Follow-up Study to Evaluate the Safety and Efficacy of FCN-159 in Pediatric Participants With Neurofibromatosis Type 1 · Phase 1, PHASE2 · not yet recruiting
NCT05997602 — To Evaluate the Efficacy, Safety, and PK Characteristics of FCN-159 in Pediatric Patients With Refractory/Recurrent LCH · 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 NCT06569420 (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 Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Last refreshed: 26 August 2024

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/NCT06569420.

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