NCT02321501

Ceritinib and Everolimus in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIB-IV Non-small Cell Lung Cancer

Active, enrolled Phase 1 Last updated 10 November 2025

What this trial tests

Phase 1 trial testing Ceritinib in ALK Positive in 37 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

22 June 2016

Primary endpoint
31 December 2026

31 December 2026

Quick facts

Lead sponsor	M.D. Anderson Cancer Center
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	37
Start date	22 June 2016
Primary completion	31 December 2026
Estimated completion	31 December 2026
Sites	1 location across United States

Drugs / interventions tested

• Ceritinib (ceritinib) — full drug profile →
• Everolimus (everolimus) — full drug profile →
• Laboratory Biomarker Analysis
• Pharmacological Study — full drug profile →

Conditions studied

• ALK Positive — all drugs for ALK Positive →
• Locally Advanced Malignant Solid Neoplasm — all drugs for Locally Advanced Malignant Solid Neoplasm →
• Metastatic Malignant Solid Neoplasm — all drugs for Metastatic Malignant Solid Neoplasm →
• ROS1 Gene Rearrangement — all drugs for ROS1 Gene Rearrangement →

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

18 and older, any sex, with ALK Positive or Locally Advanced Malignant Solid Neoplasm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase I trial studies the side effects and best dose of ceritinib and everolimus in treating patients with solid tumors that have spread from where they started to nearby tissue or lymph nodes (locally advanced) or to other places in the body (metastatic) or stage IIIB-IV non-small cell lung cancer. Ceritinib and everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Publications & conference data

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

1. 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
2. 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
3. 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
4. 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
5. ALK-positive lung cancer: a moving target.
   Schneider JL, Lin JJ, Shaw AT. · · 2023 · cited 131× · PMID 36797503 · DOI 10.1038/s43018-023-00515-0
6. Dysregulations in the PI3K pathway and targeted therapies for head and neck squamous cell carcinoma.
   Cai Y, Dodhia S, Su GH. · · 2017 · cited 67× · PMID 28108737 · DOI 10.18632/oncotarget.14729
7. Tumor Resistance against ALK Targeted Therapy-Where It Comes From and Where It Goes.
   Sharma GG, Mota I, Mologni L, Patrucco E, et al · · 2018 · cited 65× · PMID 29495603 · DOI 10.3390/cancers10030062
8. 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