Last reviewed · How we verify
NCT02973763
Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of Alflutinib in Advanced Non Small Cell Lung Cancer
Phase 1 trial testing Alflutinib in NSCLC in 14 participants. Terminated before completion.
4 February 2021
Quick facts
| Lead sponsor | Allist Pharmaceuticals, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 14 |
| Start date | 30 December 2016 |
| Primary completion | 4 February 2021 |
| Estimated completion | 1 August 2023 |
Drugs / interventions tested
- Alflutinib — full drug profile →
Conditions studied
- NSCLC — all drugs for NSCLC →
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):
-
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT02973763
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Alflutinib
Trials testing the same drug.
- NCT03452592 — Efficacy and Safety of Alflutinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer Patients With T790M · Phase 2 · terminated
- NCT03127449 — AST2818 in Advanced Non-Small Cell Lung Cancer With EGFR Mutations · NA · terminated
Other recruiting trials for NSCLC
Currently open trials in the same condition.
- NCT07479277 — Progel Platinum for Air Leak Reduction After VATS Lobectomy for NSCLC · NA · recruiting
- NCT07323732 — A Study of BIO 300 and Thoracic Radiation Therapy in People With Non-Small Cell Lung Cancer and Interstitial Lung Diseas · Phase 2 · recruiting
- NCT07274813 — A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX37 in Advanced/Metastatic Solid Tumors · EARLY_PHASE1 · recruiting
- NCT07325864 — Molecular Phenotyping of Primitive Lung Cancer and Metastatic Site · recruiting
- NCT07169552 — HC010 in First-line PD-L1 Positive Advanced NSCLC Patients · Phase 2 · recruiting
Other Allist Pharmaceuticals, Inc. trials
Trials by the same sponsor.
- NCT07010419 — A Study to Assess the Efficacy and Safety of Firmonertinib Versus Placebo for Adjuvant Treatment in Participants With St · Phase 3 · recruiting
- NCT06416410 — JAB-21822 Combined With JAB-3312 Compared SOC in the First Line for Treatment of Advanced Non-small Cell Lung Cancer Wit · Phase 3 · recruiting
- NCT06162169 — A Clinical Trial to Evaluate JAB-21822 Drug-drug Interactions in Healthy Subjects · Phase 1 · completed
- NCT06008288 — A Phase II Study Evaluating JAB-21822 Monotherapy in Adult Patients With Pancreatic Cancer and Other Solid Tumors Harbor · Phase 2 · recruiting
- NCT05920941 — Mass Balance Study of [14C]JAB-21822 · Phase 1 · completed
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 NCT02973763 (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 Allist Pharmaceuticals, Inc.
- Last refreshed: 3 April 2025
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