NCT02299505 is a Phase 1 clinical trial of ceritinib in Non-Small Cell Lung Cancer, sponsored by Novartis Pharmaceuticals.

Who is sponsoring NCT02299505?

NCT02299505 is sponsored by Novartis Pharmaceuticals.

What drugs are being tested in NCT02299505?

Interventions in NCT02299505: ceritinib.

What condition does NCT02299505 study?

NCT02299505 studies Non-Small Cell Lung Cancer.

Is NCT02299505 still recruiting?

NCT02299505 is currently completed. Last updated 9 February 2022.

Last reviewed 2022-02-09 · How we verify

NCT02299505

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

Pharmacokinetic and Safety Study of Lower Doses of Ceritinib Taken With a Low-fat Meal Versus 750 mg of Ceritinib in the Fasted State in Adult Patients With (ALK-positive) Metastatic Non-small Cell Lung Cancer (NSCLC)

Completed Phase 1 Last updated 9 February 2022

What this trial tests

Phase 1 trial testing ceritinib in Non-Small Cell Lung Cancer in 306 participants. Completed in 6 March 2020.

Timeline

9 April 2015

Primary endpoint
16 June 2016

6 March 2020

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	306
Start date	9 April 2015
Primary completion	16 June 2016
Estimated completion	6 March 2020
Sites	73 locations across Italy, Colombia, Malaysia, Taiwan, Poland, South Korea, Lebanon, Netherlands

Drugs / interventions tested

ceritinib (ceritinib) — full drug profile →

Conditions studied

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

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

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

Sponsor's own description

A Phase I study to assess the systemic exposure, effiacy, and safety of 450 mg ceritinib taken with a low-fat meal and 600 mg ceritinib taken with a low-fat meal as compared with that of 750 mg ceritinib taken in the fasted state in adult patients with ALK rearranged (ALK-positive) metastatic non-small cell lung cancer (NSCLC)

Publications & conference data

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

Clinical development of targeted and immune based anti-cancer therapies.
Seebacher NA, Stacy AE, Porter GM, Merlot AM. · · 2019 · cited 147× · PMID 30975211 · DOI 10.1186/s13046-019-1094-2
Brain Metastases in Oncogene-Addicted Non-Small Cell Lung Cancer Patients: Incidence and Treatment.
Remon J, Besse B. · · 2018 · cited 58× · PMID 29696132 · DOI 10.3389/fonc.2018.00088
Safety and efficacy of anaplastic lymphoma kinase tyrosine kinase inhibitors in non‑small cell lung cancer (Review).
Wang L, Wang W. · · 2021 · cited 42× · PMID 33200229 · DOI 10.3892/or.2020.7851
Phase II study of ceritinib in alectinib-pretreated patients with anaplastic lymphoma kinase-rearranged metastatic non-small-cell lung cancer in Japan: ASCEND-9.
Hida T, Seto T, Horinouchi H, Maemondo M, et al · · 2018 · cited 40× · PMID 29959809 · DOI 10.1111/cas.13721
Low-Dose Abiraterone in Metastatic Prostate Cancer: Is It Practice Changing? Facts and Facets.
Patel A, Tannock IF, Srivastava P, Biswas B, et al · · 2020 · cited 28× · PMID 32125899 · DOI 10.1200/jgo.19.00341
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
Pooled safety analyses of ALK-TKI inhibitor in ALK-positive NSCLC.
Zhu Q, Hu H, Weng DS, Zhang XF, et al · · 2017 · cited 23× · PMID 28606126 · DOI 10.1186/s12885-017-3405-3
Personalized treatment options for ALK-positive metastatic non-small-cell lung cancer: potential role for Ceritinib.
El-Osta H, Shackelford R. · · 2015 · cited 15× · PMID 26622190 · DOI 10.2147/pgpm.s71100

Verify or expand the search:

Other trials of ceritinib

Trials testing the same drug.

NCT05834348 — A Study to Learn About the Effectiveness of Cancer Medicines in Patients With Metastatic Non-small Cell Lung Cancer in N · completed
NCT04647110 — Real-world Therapy of ALK-positive NSCLC in Sweden: the Sequencing of ALK Tyrosine Kinase Inhibitor Drugs and Their Ther · completed
NCT02584933 — Roll-over Study to Allow Access to Certinib (LDK378) for Patients Who Are on Ceritinib Treatment in a Novartis-sponsored · Phase 4 · active not recruiting
NCT02422589 — A Phase I, Multi-center, Open Label, Drug-drug Interaction Study to Assess the Effect of Ceritinib on the Pharmacokineti · Phase 1 · completed
NCT05100134 — Managed Access Programs for LDK378, Ceritinib · no longer available

Other recruiting trials for Non-Small Cell Lung Cancer

Currently open trials in the same condition.

NCT07140315 — DK222 Study at Hopkins · Phase 1 · recruiting
NCT07487883 — Cadherin 3(CDH3)-Targeted PET in Lung Malignant Tumors · recruiting
NCT07413757 — CHOICE:Decision Factor of EGFR-TKI in Chinese IV NSCLC · recruiting
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 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 NCT02299505 (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: 9 February 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/NCT02299505.

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