Sunvozertinib Plus Anlotinib as 1L Treatment in EGFR Mutant Advanced NSCLC-RW
ConditionNon-small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHunan Province Tumor Hospital
About this trial
This is a phase II, open-label, single-arm, single-center clinical study to evaluate the preliminary efficacy of sunvozertinib in combination with anlotinib in patients with EGFR-sensitive mutations and co-mutations in locally advanced or metastatic treatment-naive non-small cell lung cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.
Age ≥ 18 years.
Histopathology or cytology confirmed and recorded local progression or metastatic non-small cell lung cancer without systemic treatment.
EGFR-sensitive mutations confirmed by an accredited local laboratory, including exon 19 deletions, exon 21 L858R point mutations, and T790M mutations, combined with co-mutations, including but not limited to TP53, PIK3CA, catenin beta-1 (CTNB1), and retinoblastoma (RB1).
Disqualifiers
Prior systemic therapy for locally advanced or metastatic disease.
Treatment with molecules such as EGFR, VEGFR antibodies within 4 weeks prior to the first dose of study drug.
Have received radiation within 14 days prior to the first dose or have not recovered from radiation-related toxicity. Chest and extra-brain palliative radiotherapy, stereotactic radiosurgery, and stereotactic body radiotherapy may be performed 7 days prior to the first dose.
Ongoing (or inability to discontinue) possibly potent CYP1A2, CYP3A inhibitor (1 week), or inducer (2 weeks) drug therapy or herbal supplements within 1-2 weeks prior to the first dose.
Trial design
Design model
Single group
Treatments tested in this trial
sunvozertinib in combination with Anlotinib
DrugSunvozertinib 300 mg once daily (QD) with Anlotinib 8mg once daily （QD in Day 1-14），21 days in one cycle.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Treatment GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Progression-free survival (PFS)
To assess progression-free survival of patients treated by sunvozertinib according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator, define as first dose to first documented disease progression assessed by investigator or death due to any cause
Time frame
Time from first subject dose to study completion, or up to 36 monthSecondary outcomes
1
Objective Response Rate (ORR)
To assess sunvozertinib overall response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator, define as the proportion of subjects who have a complete response (CR) or a partial response (PR)
Time frame
Time from first dose to last dose, or up to 24 month2
Overall survival (OS)
To assess overall survival, define as first dose to the death of the subject due to any cause
Time frame
Time from first subject dose to study completion, or up to 36 month3
Duration of Response (DoR)
To assess duration of response for subjects with CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator , defined as the time from the first documented CR or PR to disease progression or death
Time frame
Time from first subject dose to study completion, or up to 36 month4
Adverse events (AEs) according to CTCAE 5.0
Number of participants with adverse events (AEs) according to CTCAE 5.0
Time frame
From first dose until 28 days after the last dose, up to 24 monthSponsors and contacts
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Source ClinicalTrials.gov