Not Yet RecruitingPhase 2

A Study of Sunvozertinib Combined With Anlotinib in Local Advanced or Metastatic Non-small Cell Lung Cancer

45 participantsStarted 2024-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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:
✕. 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

What they're measuring

ORR

Timeframe: initiate from first dose until the date of confirmed response, assessed up to 24 weeks

Trial details

NCT IDNCT06182761

SponsorShanghai Zhongshan Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01

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