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

Nanjing Medical University

Status and phase: Enrolling; Phase 2

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Drug: Fruquintinib，Sintilimab，Pemetrexed，Carboplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT04956146

HMPL-013-FLAG-L101

Details and patient eligibility

About

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.

Enrollment: 46 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Histological or cytologically confirmed small cell lung cancer (SCLC), including lung cancer mixed with SCLC and NSCLC.
2. Diagnosed with other malignant diseases other than NSCLC within 5 years.
3. Have participated in other interventional clinical research treatments now or within 4 weeks.
4. Have previously received multi-targeted kinase inhibitors therapy.
5. Have active autoimmune diseases requiring systemic treatment within 2 years.
6. Received systemic glucocorticoid therapy or immunosuppressive therapy within 2 weeks.
7. Clinically uncontrollable pleural effusion/abdominal effusion.
8. Vaccinated vaccines or attenuated vaccines within 4 weeks before the group;
9. Pregnant or breastfeeding females.
10. Other serious hazards to the safety of patients.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 1 patient group

Fruquintinib Combined With Sintilimab and Chemotherapy

Experimental group

Treatment:

Drug: Fruquintinib，Sintilimab，Pemetrexed，Carboplatin