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Not yet recruitingNCT06182761WUKONG-9Updated Dec 27, 2023

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

A Phase 2 interventional study of Sunvozertinib combination with Anlotinib in NSCLC, sponsored by Shanghai Zhongshan Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-27.

Sponsored by Shanghai Zhongshan Hospital · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2026, 9 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 2
Study type
Interventional
Enrollment
45
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • NSCLC
03

In context

Lead sponsor

Shanghai Zhongshan Hospital is the lead sponsor of 648 studies on the registry; 289 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.
  2. Pathologically confirmed non-squamous NSCLC. Locally advanced or metastatic NSCLC
  3. EGFR sensitive mutations confirmed by accredited local laboratories, including 19del、L858R and T790M。
  4. Intolerant or refuses, or not suitable for systemic chemotherapy.
  5. 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.
  6. World Health Organization performance status of 0 to 1
  7. Life expectancy >12 weeks at Day 1.
  8. At least 1 lesion to be measured
  9. 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.
  10. Male patients must be willing to use barrier contraception

Exclusion criteria

Exclusion Criteria:

  1. Any known RET rearrangement, BRAF V600E mutation, NTRK fusion, MET ex14 skip mutation, MET amplification (defined as tissue detection GCN ≥ 5 by NGS)
  2. Any concurrent and/or other active malignancy within 2 years
  3. Major surgery within 4 weeks of the first dose of IP
  4. Any unresolved toxicities from prior therapy.
  5. 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
  6. Any evidence of severe or uncontrolled systemic diseases.
  7. 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

  8. 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
  9. Severe allergies to Sunvozertinib and Anlotinib
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
45 participants (estimated)

Study arms

  • Experimental
    sunvozertinib in combination with Anlotinib

    Drug: Sunvozertinib combination with Anlotinib

Interventions

  • DrugSunvozertinib combination with Anlotinib

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

06

What researchers measure

Primary outcomes

  1. ORR

    Objective response rate (ORR) as assessed by the investigator according to RECIST 1.1 criteria.

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

Secondary outcomes

  1. PFS

    PFS as assessed by the investigator according to RECIST 1.1

    Time frame: initiate from first dose, every 6 weeks until PD or study close, an average of 1 year

  2. OS

    initiate from first dose to death from any cause

    Time frame: through study completion, an average of 1.5 years

  3. DoR

    The period from the first judgment of CR or PR to PD

    Time frame: an average of 1 year

  4. AE

    TRAE as assessed by the investigator according to CTCAE 5.0

    Time frame: through study completion, an average of 1 year

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06182761
Responsible party
Sponsor
First posted
Dec 27, 2023
Start date
Jan 2024 (estimated)
Primary completion
Jan 2026 (estimated)
Completion
Jul 2028 (estimated)
Last update
Dec 27, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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