Fruquintinib Combined With Sintilimab and Chemotherapy in the Treatment of Non-Small Cell Lung Cancer

  • STATUS
    Recruiting
  • End date
    Sep 30, 2024
  • participants needed
    46
  • sponsor
    The First Affiliated Hospital with Nanjing Medical University
Updated on 6 December 2021
progressive disease
pemetrexed
carboplatin
EGFR
cancer chemotherapy
targeted therapy
lung carcinoma
squamous non-small cell lung cancer
non-squamous non-small cell lung cancer

Summary

A phase II study to assess the efficacy and safety of Fruquintinib Combined With Sintilimab and Chemotherapy as a first-line treatment in patients with unresectable or metastatic advanced Wild-type Genotype non-squamous Non-small Cell Lung Cancer.

Details
Condition Non-Small Cell Lung Cancer
Treatment Fruquintinib,Sintilimab,Pemetrexed,Carboplatin
Clinical Study IdentifierNCT04956146
SponsorThe First Affiliated Hospital with Nanjing Medical University
Last Modified on6 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Voluntary provision of informed consent
Males or females aged 18-75
Histological or cytologically confirmed NSCLC, metastatic or non-resectable (stage IIIB-)
Not suitable for targeted therapy (patients with non-squamous NSCLC have no EGFR, ALK, gene mutation)
At least one lesion can be measured by imaging
Have not received systemic treatment in the past
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1
Life expectancy 12 weeks
Female of childbearing age must have a negative pregnancy test (serum or urine) within 7 days before enrolment

Exclusion Criteria

Histological or cytologically confirmed small cell lung cancer (SCLC), including lung cancer mixed with SCLC and NSCLC
Diagnosed with other malignant diseases other than NSCLC within 5 years
Have participated in other interventional clinical research treatments now or within 4 weeks
Have previously received multi-targeted kinase inhibitors therapy
Have active autoimmune diseases requiring systemic treatment within 2 years
Received systemic glucocorticoid therapy or immunosuppressive therapy within 2 weeks
Clinically uncontrollable pleural effusion/abdominal effusion
Vaccinated vaccines or attenuated vaccines within 4 weeks before the group
Pregnant or breastfeeding females
Other serious hazards to the safety of patients
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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