NCT06436144Not yet recruitingPhase 2
Osimertinib and Etoposide as First-Line Treatment in Osimertinib-Resistant Advanced EGFR-Mutant NSCLC
A Single-Center, Prospective, Single-Arm, Observational Study Evaluating the Efficacy and Safety of Osimertinib Combined With Etoposide as First-Line Treatment in Patients With Osimertinib-Resistant or -Insensitive, Advanced EGFR-Mutant Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 30 May 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Osimertinib, though a standard first-line treatment for EGFR-mutant advanced NSCLC, shows primary resistance in 10-30% of patients, leading to disease progression within 3-4 months. This resistance is linked to co-mutations in genes like TP53, RB1, and PIK3CA, among others. Studies indicate that Topo II inhibitor Etoposide (VP-16) can reduce cell survival, enhance DNA damage, and delay resistance in Osimertinib-resistant cells, suggesting a potential combination therapy to manage resistance.This study is a single-center, prospective, single-arm study evaluating the efficacy and safety of osimertinib combined with etoposide as a first-line treatment in patients with osimertinib-resistant or -insensitive advanced non-small cell lung cancer (NSCLC). The study focuses on patients with advanced NSCLC (stage IIIB or IV) with EGFR-sensitive mutations who developed slow resistance to osimertinib and for whom secondary biopsy after resistance did not identify any therapeutic targets.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 93 (estimated)
- First submitted
- 21 May 2024
- Start date
- Jun 2024
- Primary completion date
- Jun 2029
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Diseases
- Lung cancer
- NCT number
- NCT06436144
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 93
- From Jun 2024 to the primary completion date, Jun 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently receiving or planning to receive other anti-cancer therapies.
Other
- Having contraindications to osimertinib or etoposide.
- Harboring known targetable osimertinib resistance mechanisms.
Who the study is looking for
- Age 18 to 79 years.
- Locally advanced (stage IIIB) or metastatic (stage IV) EGFR-mutant NSCLC.
- Harboring an EGFR sensitizing mutation (Exon 19 deletion or L858R).
- Received at least two cycles of first-line osimertinib treatment, with a best response of stable disease or slow progression.
- Life expectancy greater than 3 months.
- At least one measurable tumor lesion meeting the following criteria:
- 1.No prior radiation therapy; 2.Measurable by chest CT or PET-CT, with a longest diameter ≥ 10 mm at baseline (short axis ≥ 15 mm for lymph nodes); 3.Amenable to accurate repeated measurements.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.