NCT06182761Not yet recruitingPhase 2
A Study of Sunvozertinib Combined With Anlotinib in Local Advanced or Metastatic Non-small Cell Lung Cancer
Efficacy and Safety of Sunvozertinib With Anlotinib in EGFR-TKIs Resistant EGFR-sensitive Mutated Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC): a Prospective, Single-arm, Phase II Trial
Source: ClinicalTrials.gov · Last updated 27 Dec 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The study will evaluate the efficacy and safety of treatment with sunvozertinib in combination with Anlotinib in patients whose disease has progressed following first-line EGFR-TKIs treatment.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- First submitted
- 1 Dec 2023
- Start date
- Jan 2024
- Primary completion date
- Jan 2026
- Lead sponsor
- Shanghai Zhongshan Hospital
- Diseases
- Lung cancer
- NCT number
- NCT06182761
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 45
- From Jan 2024 to the primary completion date, Jan 2026
- 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
- Any concurrent and/or other active malignancy within 2 years
- Major surgery within 4 weeks of the first dose of IP
- Any unresolved toxicities from prior therapy.
- Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of Sunvozertinib and Anlotinib
Other illness
- Past medical history of ILD (interstitial lung disease)/pneumonitis, drug-induced ILD/pneumonitis, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD/pneumonitis
- Any evidence of severe or uncontrolled systemic diseases.
- Severe allergies to Sunvozertinib and Anlotinib
Lab values
- Any of the following cardiac criteria:
- Mean resting QTc \>470 msec ii) Any clinically important abnormalities in rhythm, conduction, or morphology of resting electrocardiogram iii) Any factors that increase the risk of QTc prolongation or risk of arrhythmic events
Other
- Any known RET rearrangement, BRAF V600E mutation, NTRK fusion, MET ex14 skip mutation, MET amplification (defined as tissue detection GCN ≥ 5 by NGS)
Who the study is looking for
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.
- Pathologically confirmed non-squamous NSCLC. Locally advanced or metastatic NSCLC
- EGFR sensitive mutations confirmed by accredited local laboratories， including 19del、L858R and T790M。
- Intolerant or refuses, or not suitable for systemic chemotherapy.
- Progressed after EGFR-TKI targeted therapy or are intolerant to standard treatment; if carry T790M mutation, need to be treated with osimertinib or other third-generation EGFR-TKI.
- World Health Organization performance status of 0 to 1
- Life expectancy \>12 weeks at Day 1.
- At least 1 lesion to be measured
- Females must be using highly effective contraceptive measures, and must have a negative pregnancy test prior to start of dosing if of childbearing potential, or must have evidence of non-childbearing potential by fulfilling criteria at screening.
- Male patients must be willing to use barrier contraception
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Related publications
- Sunvozertinib: a Promising Oral EGFR Inhibitor Approved for NSCLC with EGFR Ex20ins Mutations.Invest New Drugs · 2025 · PMID 41212379
This page is information, not medical advice. Discuss any trial with your doctor.