NCT02098954

Erlotinib Combined With Chemotherapy in TKI Resistant Non-Small Cell Lung Cancers

Status unknown Phase 2 Last updated 27 December 2023

What this trial tests

Phase 2 trial testing Gemcitabine platinum combined with erlotinib in Carcinoma, Non-Small Cell Lung in 40 participants. Status unknown.

Timeline

1 July 2014

Primary endpoint
1 December 2024

12 December 2025

Quick facts

Lead sponsor	Hunan Province Tumor Hospital
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	1 July 2014
Primary completion	1 December 2024
Estimated completion	12 December 2025
Sites	1 location across China

Drugs / interventions tested

• Gemcitabine platinum combined with erlotinib — full drug profile →

Conditions studied

• Carcinoma, Non-Small Cell Lung — all drugs for Carcinoma, Non-Small Cell Lung →
• EGFR Gene Mutation — all drugs for EGFR Gene Mutation →

Sponsor

Hunan Province Tumor Hospital

Who can join

Adults 18 to 75, any sex, with Carcinoma, Non-Small Cell Lung or EGFR Gene Mutation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Numerous evidences verified that erlotinib could dramatically improve the PFS and OS of non-small cell lung cancers who harbor EGFR sensitive mutations, however, primary or secondary resistance will be developed after TKI treatment, doctors do plenty of researches to overcome TKI resistance. FAST ACT-2 study present that, first line erlotinib combined with chemotherapy could improved mOS to more than 30 months in NSCLCs who harbor EGFR sensitive mutations, several study shows that sensitive mutations still exist after TKI resistance, because of the next generation TKIs(such as BIBW2992) are not avaliable at present, agents for met amplification(such as Crizotinib) are so expensive that many Chinese patients could not support. Thus, the investigators hypothesis that, after first line TKI treatment, the patients who developed TKI resistance could still benefit from second line TKI combined with chemotherapy.

Publications & conference data

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

1. Therapeutic strategies utilized in the setting of acquired resistance to EGFR tyrosine kinase inhibitors.
   Yu HA, Riely GJ, Lovly CM. · · 2014 · cited 66× · PMID 25303979 · DOI 10.1158/1078-0432.ccr-13-2437
2. Drug resistance of targeted therapy for advanced non-small cell lung cancer harbored EGFR mutation: from mechanism analysis to clinical strategy.
   Zhao Y, Wang H, He C. · · 2021 · cited 26× · PMID 34661758 · DOI 10.1007/s00432-021-03828-8
3. EGFR Mutation Positive Stage IV Non-Small-Cell Lung Cancer: Treatment Beyond Progression.
   Van Assche K, Ferdinande L, Lievens Y, Vandecasteele K, et al · · 2014 · cited 11× · PMID 25538894 · DOI 10.3389/fonc.2014.00350
4. 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