Status:
NOT_YET_RECRUITING
A Study of Sunvozertinib Combined With Anlotinib in Local Advanced or Metastatic Non-small Cell Lung Cancer
Lead Sponsor:
Shanghai Zhongshan Hospital
Conditions:
NSCLC
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- Any known RET rearrangement, BRAF V600E mutation, NTRK fusion, MET ex14 skip mutation, MET amplification (defined as tissue detection GCN ≥ 5 by NGS)
- 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.
- 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.
- Any of the following cardiac criteria:
- i) 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
- 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
- Severe allergies to Sunvozertinib and Anlotinib
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06182761
Start Date
January 1 2024
End Date
July 1 2028
Last Update
December 27 2023
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