NCT03486496: Geber

Gefitinib and Berberine in the First-line Treatment of Lung Adenocarcinoma With EGFR Mutation

Status unknown Phase 2 Last updated 3 April 2018

What this trial tests

Phase 2 trial testing gefitinib in Lung Adenocarcinoma in 50 participants. Status unknown.

Timeline

5 June 2018

Primary endpoint
1 June 2019

1 February 2020

Quick facts

Lead sponsor	Fujian Cancer Hospital
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	5 June 2018
Primary completion	1 June 2019
Estimated completion	1 February 2020
Sites	1 location across China

Drugs / interventions tested

• gefitinib (gefitinib) — full drug profile →
• Berberine — full drug profile →

Conditions studied

• Lung Adenocarcinoma — all drugs for Lung Adenocarcinoma →
• EGFR Mutation — all drugs for EGFR Mutation →

Sponsor

Fujian Cancer Hospital

Who can join

18 and older, any sex, with Lung Adenocarcinoma or EGFR Mutation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Rationale:

Advanced non-small-cell lung cancer (NSCLC) patients harboring epidermal growth factor receptor (EGFR) mutations (del19 or L858R) show an impressive progression-free survival between 9 and 11 months when treated with gefitinib. Combination of gefitinib and berberine could improve efficacy in lung cancer with EGFR mutation in vivo and vitro. The investigators hypothesize that progression-free survival could be improved by combination of gefitinib and berberine.

Publications & conference data

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

1. Natural Nrf2 Inhibitors: A Review of Their Potential for Cancer Treatment.
   Zhang J, Xu HX, Zhu JQ, Dou YX, et al · · 2023 · cited 49× · PMID 37416770 · DOI 10.7150/ijbs.82401
2. Modulation of the tumor microenvironment by natural agents: implications for cancer prevention and therapy.
   Zubair H, Khan MA, Anand S, Srivastava SK, et al · · 2022 · cited 44× · PMID 32470379 · DOI 10.1016/j.semcancer.2020.05.009
3. Targeting Autophagy with Natural Products as a Potential Therapeutic Approach for Cancer.
   Al-Bari MAA, Ito Y, Ahmed S, Radwan N, et al · · 2021 · cited 34× · PMID 34575981 · DOI 10.3390/ijms22189807
4. An Insight Into the Molecular Mechanism of Berberine Towards Multiple Cancer Types Through Systems Pharmacology.
   Guo P, Cai C, Wu X, Fan X, et al · · 2019 · cited 32× · PMID 31447670 · DOI 10.3389/fphar.2019.00857
5. Evaluation of the Cytotoxic Activity and Anti-Migratory Effect of Berberine-Phytantriol Liquid Crystalline Nanoparticle Formulation on Non-Small-Cell Lung Cancer In Vitro.
   Alnuqaydan AM, Almutary AG, Azam M, Manandhar B, et al · · 2022 · cited 31× · PMID 35745691 · DOI 10.3390/pharmaceutics14061119
6. Lipid metabolism reprogramming in endometrial cancer: biological functions and therapeutic implications.
   Wang X, Li Y, Hou X, Li J, et al · · 2024 · cited 22× · PMID 39256811 · DOI 10.1186/s12964-024-01792-7
7. Natural anti-cancer products: insights from herbal medicine.
   Cui D, Zhang C, Zhang L, Zheng J, et al · · 2025 · cited 9× · PMID 40490812 · DOI 10.1186/s13020-025-01124-y
8. Natural Product-Based Glycolysis Inhibitors as a Therapeutic Strategy for Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor-Resistant Non-Small Cell Lung Cancer.
   Park W, Han JH, Wei S, Yang ES, et al · · 2024 · cited 9× · PMID 38255882 · DOI 10.3390/ijms25020807