Health Trials

The Study Of Andamertinib Plus Anlotinib In Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

ConditionNon-Small Cell Lung Cancer (NSCLC, Locally Advanced or Metastatic, Second-line
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFudan University

About this trial

This study is a single arm study to access the anti-tumor efficacy and safety of Andamertinib plus Anlotinib in patients with locally advanced or metastatic non-small cell lung cancer previously treated with third-generation EGFR-TKI.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Able to understand and voluntarily sign the written informed consent form.

Aged ≥ 18 years, male or female.

Non-small-cell lung cancer (NSCLC) confirmed histologically or cytologically, clinically diagnosed as unresectable and ineligible for curative concurrent chemoradiotherapy, including locally advanced (stage ⅢB/ⅢC), metastatic or recurrent (stage Ⅳ) NSCLC.

Harboring EGFR mutations (including exon19 deletions and exon21 L858R mutation), with documented disease progressed following only one prior line of third-generation EGFR-TKI therapy.

Disqualifiers

Diagnosis of other malignant diseases within 3 years prior to first study drug administration, except for radically treated basal cell carcinoma of the skin, squamous-cell carcinoma of the skin, and/or radically resected carcinoma in-situ.

Presence of any of the following genetic alterations: ALK fusion, ROS1 fusion, BRAF V600 mutation, NTRK fusion, MET exon14 skipping mutation, MET amplification, RET fusion, KRAS G12C mutation, HER2 mutation, NRG1 fusion.

Central squamous-cell carcinoma with high risk of massive hemoptysis.

Toxicities from prior anti-tumour therapy have not recovered to Grade≤1, except for alopecia, fatigue and other toxicities judged by the investigator to carry low safety risk.

Trial design

Design model

Single group

Treatments tested in this trial

  • Andamertinib

    Drug

    Andamertinib: 160mg, QD, Q3W

  • Anlotinib

    Drug

    Anlotinib: 12mg/10mg, QD, d1-d14, Q3W

Treatment groups

34 Participants
are divided into 1 treatment group
Group A: Andamertinib + AnlotinibExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

PFS

Progression-free survival (PFS per RECIST 1.1) is defined as the time from treatment to the date of first documentation of disease progression or death, whichever occurs first

Time frame
12 months after the last subject participating in

Secondary outcomes

1

ORR

The proportion of subjects with complete response (CR) and partial response (PR) in total subjects

Time frame
12 months after the last subject participating in
2

DCR

The proportion of subjects with complete response (CR), partial response (PR)and stable disease in(SD) in total subjects

Time frame
12 months after the last subject participating in
3

DoR

DoR (per RECIST 1.1) is defined as the time from the date for first documented response of complete response (CR) or partial response (PR) to the date of first documented of disease progression or death, whichever occurs first.

Time frame
12 months after the last subject participating in
4

OS

Defined as the time from treatment to all-cause death

Time frame
24 months after the last subject participating in

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fudan University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: