NCT05489731: VIC-1911

VIC-1911 Combined With Osimertinib for EGFR -Mutant Non-small Cell Lung Cancer

Status unknown Phase 1 Last updated 15 June 2023

What this trial tests

Phase 1 trial testing VIC-1911 in Advanced Non-small Cell Lung Cancer in 72 participants. Status unknown.

Timeline

21 September 2022

Primary endpoint
24 February 2024

24 April 2024

Quick facts

Lead sponsor	Jiesi Yingda Pharmaceutical Technology (Suzhou) Co., Ltd.
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	72
Start date	21 September 2022
Primary completion	24 February 2024
Estimated completion	24 April 2024
Sites	1 location across China

Drugs / interventions tested

• VIC-1911
• Osimertinib Mesylate Tablets — full drug profile →

Conditions studied

• Advanced Non-small Cell Lung Cancer — all drugs for Advanced Non-small Cell Lung Cancer →

Sponsor

Jiesi Yingda Pharmaceutical Technology (Suzhou) Co., Ltd.

Who can join

Adults 18 to 75, any sex, with Advanced Non-small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a nonrandomized, open phase I dose escalation and extension clinical study designed to evaluate Aurora A inhibitor VIC-1911 tablets in combination with oxitinib in Chinese patients with advanced non-small cell lung cancer The safety, tolerability, pharmacokinetic characteristics and preliminary antitumor efficacy were analyzed.

The entire study included the screening period (28 days prior to initialadministration of the investigational drug) and the treatment period (Cycle) EoT is defined as disease progression or intolerable toxicity or premature withdrawal Out\]) and the safety follow-up period (28 days after EoT). During dose increments and expansions, subjects followed Safety assessment, PK blood collection, imaging examination and efficacy assessment were performed during the visit plan. Observation subject The safety, tolerability, and occurrence of DLT until disease progression, occurrence of intolerable toxicity, Death, withdrawal of informed consent, loss of follow-up or termination of the study by the sponsor shall prevail.

Publications & conference data

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

1. Clinical translation for targeting DNA damage repair in non-small cell lung cancer: a review.
   Mao X, Lee NK, Saad SE, Fong IL. · · 2024 · cited 11× · PMID 38496700 · DOI 10.21037/tlcr-23-742
2. Resistance of Lung Cancer to EGFR-Specific Kinase Inhibitors: Activation of Bypass Pathways and Endogenous Mutators.
   Marrocco I, Yarden Y. · · 2023 · cited 10× · PMID 37894376 · DOI 10.3390/cancers15205009
3. Strategies to Overcome Resistance to Osimertinib in EGFR-Mutated Lung Cancer.
   Romaniello D, Morselli A, Marrocco I. · · 2025 · cited 4× · PMID 40243603 · DOI 10.3390/ijms26072957
4. A momentous progress update: epidermal growth factor receptor inhibitors as viable agents for combating cancer.
   Jangra N, Sharma B, Kumar D, Kapoor A. · · 2025 · PMID 40630673 · DOI 10.1039/d4md00799a