Last reviewed · How we verify

NCT02973763

Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of Alflutinib in Advanced Non Small Cell Lung Cancer

Terminated Phase 1 Last updated 3 April 2025
What this trial tests

Phase 1 trial testing Alflutinib in NSCLC in 14 participants. Terminated before completion.

Timeline
30 December 2016
Primary endpoint
4 February 2021
1 August 2023

Quick facts

Lead sponsorAllist Pharmaceuticals, Inc.
PhasePhase 1
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment14
Start date30 December 2016
Primary completion4 February 2021
Estimated completion1 August 2023

Drugs / interventions tested

Conditions studied

Sponsor

Allist Pharmaceuticals, Inc. — full company profile →

Who can join

Adults 18 to 65, any sex, with NSCLC. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Alflutinib Mesylate Tablets is a Epidermal Growth Factor Receptor (EGFR) mutation selective Tyrosine Kinase Inhibitor which can efficient suppress the EGFR T790M drug-resistant mutation tumor cell in Xenograft mouse model. This study aims at local advanced or metastatic non-small cell lung cancer patients with T790M drug-resistant mutation.

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. Therapeutic advances of targeting receptor tyrosine kinases in cancer.
    Tomuleasa C, Tigu AB, Munteanu R, Moldovan CS, et al · · 2024 · cited 133× · PMID 39138146 · DOI 10.1038/s41392-024-01899-w
  3. Safety, Clinical Activity, and Pharmacokinetics of Alflutinib (AST2818) in Patients With Advanced NSCLC With EGFR T790M Mutation.
    Shi Y, Zhang S, Hu X, Feng J, et al · · 2020 · cited 78× · PMID 32007598 · DOI 10.1016/j.jtho.2020.01.010
  4. A real-world study of the efficacy and safety of furmonertinib for patients with non-small cell lung cancer with EGFR exon 20 insertion mutations.
    Sa H, Shi Y, Ding C, Ma K. · · 2023 · cited 21× · PMID 37004599 · DOI 10.1007/s00432-023-04726-x
  5. Clinical trials of tyrosine kinase inhibitors for lung cancer in China: a review.
    Su S, Wu YL. · · 2017 · cited 19× · PMID 28784178 · DOI 10.1186/s13045-017-0514-z
  6. Effect of autoinduction and food on the pharmacokinetics of furmonertinib and its active metabolite characterized by a population pharmacokinetic model.
    Zou HX, Zhang YF, Zhong DF, Jiang Y, et al · · 2022 · cited 8× · PMID 34789919 · DOI 10.1038/s41401-021-00798-y
  7. A Comprehensive Review of Contemporary Literature for Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors in Non-Small Cell Lung Cancer and Their Toxicity.
    Lee CS, Sharma S, Miao E, Mensah C, et al · · 2020 · cited 8× · PMID 33117017 · DOI 10.2147/lctt.s258444
  8. A Randomized, Open, Single-Centre, Crossed Study of the Effect of Food on the Pharmacokinetics of One Oral Dose of Alflutinib Mesylate Tablets (AST2818) in Healthy Male Subjects.
    Zhu S, Deng J, Tang Q, Heng J, et al · · 2020 · cited 4× · PMID 33680007 · DOI 10.22037/ijpr.2020.113112.14116

Verify or expand the search:

Other trials of Alflutinib

Trials testing the same drug.

Other recruiting trials for NSCLC

Currently open trials in the same condition.

Other Allist Pharmaceuticals, Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT02973763.

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