NCT01947608 is a clinical trial of LDK378 in Non-small Cell Lung Cancer (NSCLC), sponsored by Novartis Pharmaceuticals.

Who is sponsoring NCT01947608?

NCT01947608 is sponsored by Novartis Pharmaceuticals.

What drugs are being tested in NCT01947608?

Interventions in NCT01947608: LDK378.

What condition does NCT01947608 study?

NCT01947608 studies Non-small Cell Lung Cancer (NSCLC).

Is NCT01947608 still recruiting?

NCT01947608 is currently no longer available. Last updated 3 November 2020.

Last reviewed 2020-11-03 · How we verify

NCT01947608

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

Expanded Treatment Protocol With LDK378 in ALK(+) NSCLC

NO LONGER AVAILABLE Last updated 3 November 2020

What this trial tests

trial testing LDK378 in Non-small Cell Lung Cancer (NSCLC). No longer available.

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Status	NO LONGER AVAILABLE
Study type	EXPANDED_ACCESS
Sites	50 locations across Hong Kong, Colombia, Jordan, Mexico, Philippines, South Korea, Argentina, Thailand

Drugs / interventions tested

LDK378 — full drug profile →

Conditions studied

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

Sponsor

Novartis Pharmaceuticals — 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

Novartis-sponsored, open-label, multi-center, interventional ETP to provide LDK378 to patients with ALK (+)NSCLC, who have been pre-treated with an ALK inhibitor; except in countries where ALK inhibitors are not approved or available. The protocol will further evaluate the safety of LDK378 in patients with ALK(+) NSCLC.

Publications & conference data

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

Molecular pathways and therapeutic targets in lung cancer.
Shtivelman E, Hensing T, Simon GR, Dennis PA, et al · · 2014 · cited 150× · PMID 24722523 · DOI 10.18632/oncotarget.1891
Prevalence and natural history of ALK positive non-small-cell lung cancer and the clinical impact of targeted therapy with ALK inhibitors.
Chia PL, Mitchell P, Dobrovic A, John T. · · 2014 · cited 148× · PMID 25429239 · DOI 10.2147/clep.s69718
Spotlight on ceritinib in the treatment of ALK+ NSCLC: design, development and place in therapy.
Santarpia M, Daffinà MG, D'Aveni A, Marabello G, et al · · 2017 · cited 24× · PMID 28740365 · DOI 10.2147/dddt.s113500
A Systemic Review of Resistance Mechanisms and Ongoing Clinical Trials in ALK-Rearranged Non-Small Cell Lung Cancer.
Esfahani K, Agulnik JS, Cohen V. · · 2014 · cited 18× · PMID 25101240 · DOI 10.3389/fonc.2014.00174
Proactive management strategies for potential gastrointestinal adverse reactions with ceritinib in patients with advanced ALK-positive non-small-cell lung cancer.
Schaefer ES, Baik C. · · 2016 · cited 17× · PMID 27069372 · DOI 10.2147/cmar.s96471
Profile of ceritinib in the treatment of ALK+ metastatic non-small-cell lung cancer.
Burns MW, Kim ES. · · 2015 · cited 1× · PMID 28210149 · DOI 10.2147/lctt.s69114
Systemic therapy for echinoderm microtubule-associated protein-like 4 anaplastic lymphoma kinase non-small cell lung cancer brain metastases.
Guo J, Zinner R, Zaorsky NG, Guo W, et al · · 2016 · cited 1× · PMID 27747054 · DOI 10.21037/jtd.2016.09.09
New options in the management of intractable ALK(+) metastatic non-small-cell lung cancer.
Weise AM, Gadgeel S. · · 2014 · PMID 28210140 · DOI 10.2147/lctt.s50414

Verify or expand the search:

Other trials of LDK378

Trials testing the same drug.

NCT02450903 — LDK378 in Patients With ALK Positive NSCLC Previously Treated With Alectinib. · Phase 2 · completed
NCT02276027 — A Phase II, Open Label, Multiple Arm Study of AUY922, BYL719, INC280, LDK378 and MEK162 in Chinese Patients With Advance · Phase 2 · completed
NCT02040870 — LDK378 in Adult Chinese Patients With ALK-rearranged (ALK-positive) Advanced Non-small Cell Lung Cancer (NSCLC) Previous · Phase 1, PHASE2 · completed
NCT01685138 — LDK378 in Crizotinib naïve Adult Patients With ALK-activated Non-small Cell Lung Cancer · Phase 2 · completed
NCT01685060 — LDK378 in Adult Patients With ALK-activated NSCLC Previously Treated With Chemotherapy and Crizotinib · Phase 2 · completed

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

Currently open trials in the same condition.

NCT07361497 — A Study to Evaluate Pumitamig Versus Durvalumab Following Concurrent Chemoradiation Therapy in Participants With Unresec · Phase 3 · recruiting
NCT07288177 — Study to Assess the Efficacy and Safety of Rina-S in Participants With Non-small Cell Lung Cancer · Phase 2 · recruiting
NCT07223047 — A Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986523 Alone and in Combination With Anti-Cancer Agent · Phase 1, PHASE2 · recruiting
NCT07291037 — Phase III Study of Datopotamab Deruxtecan Versus Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic N · Phase 3 · recruiting
NCT07140016 — A Study of Gilteritinib in Adults With Advanced ALK-positive Non-small Cell Lung Cancer (NSCLC) · Phase 1 · recruiting

Other Novartis Pharmaceuticals trials

Trials by the same sponsor.

NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary · Phase 3 · not yet recruiting
NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 4 · not yet recruiting
NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan · not yet recruiting
NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy · not yet recruiting
NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · 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 NCT01947608 (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 Novartis Pharmaceuticals
Last refreshed: 3 November 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/NCT01947608.

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