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NCT02292550
Study of Safety and Efficacy of LEE011 and Ceritinib in Patients With ALK-positive Non-small Cell Lung Cancer.
Phase 1 trial testing Ribociclib in Non-small Cell Lung Cancer in 27 participants. Completed in 26 September 2018.
26 September 2018
Quick facts
| Lead sponsor | Novartis Pharmaceuticals |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 27 |
| Start date | 14 May 2015 |
| Primary completion | 26 September 2018 |
| Estimated completion | 26 September 2018 |
| Sites | 8 locations across France, Italy, Taiwan, South Korea, United States, Spain |
Drugs / interventions tested
- Ribociclib (ribociclib) — full drug profile →
- 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
This was a Phase Ib/II study of the ALK inhibitor ceritinib in combination with the CDK4/6 inhibitor LEE011 in patients with ALK-positive non-small cell lung cancer. The purpose of the study was to determine the MTD/RP2D of the LEE011 and ceritinib combination and evaluate whether the combination was safe and had beneficial effects in ALK-positive advanced non-small cell lung cancer patients. This trial did not progress to Phase II. Trial population terminated before reaching Phase II
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Small molecules in targeted cancer therapy: advances, challenges, and future perspectives.
Zhong L, Li Y, Xiong L, Wang W, et al · · 2021 · cited 1003× · PMID 34054126 · DOI 10.1038/s41392-021-00572-w -
Cyclin D1, cancer progression, and opportunities in cancer treatment.
Qie S, Diehl JA. · · 2016 · cited 527× · PMID 27695879 · DOI 10.1007/s00109-016-1475-3 -
Targeting ALK: Precision Medicine Takes on Drug Resistance.
Lin JJ, Riely GJ, Shaw AT. · · 2017 · cited 411× · PMID 28122866 · DOI 10.1158/2159-8290.cd-16-1123 -
AXL receptor tyrosine kinase as a promising anti-cancer approach: functions, molecular mechanisms and clinical applications.
Zhu C, Wei Y, Wei X. · · 2019 · cited 398× · PMID 31684958 · DOI 10.1186/s12943-019-1090-3 -
CDK4/6 Inhibitors: The Mechanism of Action May Not Be as Simple as Once Thought.
Klein ME, Kovatcheva M, Davis LE, Tap WD, et al · · 2018 · cited 308× · PMID 29731395 · DOI 10.1016/j.ccell.2018.03.023 -
Fusions in solid tumours: diagnostic strategies, targeted therapy, and acquired resistance.
Schram AM, Chang MT, Jonsson P, Drilon A. · · 2017 · cited 270× · PMID 28857077 · DOI 10.1038/nrclinonc.2017.127 -
The Strange Case of CDK4/6 Inhibitors: Mechanisms, Resistance, and Combination Strategies.
Knudsen ES, Witkiewicz AK. · · 2017 · cited 218× · PMID 28303264 · DOI 10.1016/j.trecan.2016.11.006 -
Selective inhibition of CDK4/6: A safe and effective strategy for developing anticancer drugs.
Yuan K, Wang X, Dong H, Min W, et al · · 2021 · cited 103× · PMID 33532179 · DOI 10.1016/j.apsb.2020.05.001
Verify or expand the search:
- PubMed search for NCT02292550
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02292550 (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: 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/NCT02292550.
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