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

Official title

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

Overview

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.

Interventions

• Drug Sunvozertinib combination with Anlotinib
  Sunvozertinib 300 mg once daily (QD) with Anlotinib 12mg once daily （QD in Day 1-14） ，21 days in one cycle.

Primary outcome measures

• ORR [Time frame: initiate from first dose until the date of confirmed response, assessed up to 24 weeks]

Secondary outcome measures (4)

• PFS [Time frame: initiate from first dose, every 6 weeks until PD or study close, an average of 1 year]
• OS [Time frame: through study completion, an average of 1.5 years]
• DoR [Time frame: an average of 1 year]
• AE [Time frame: through study completion, an average of 1 year]

Eligibility criteria

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
• 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 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:

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06182761 · WUKONG9

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗