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

Study Overview
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Brief Summary
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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.

Official Title
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A Single Arm,Open-label, Study of Fruquintinib Combined With Sintilimab and Chemotherapy in Patients With Unresectable or Metastatic Advanced Wild-type Genotype Non-squamous Non-small Cell Lung Cancer

Conditions
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Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
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* Drug: Fruquintinib，Sintilimab，Pemetrexed，Carboplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Voluntary provision of informed consent. Males or females aged 18-75. Histological or cytologically confirmed NSCLC, metastatic or non-resectable (stage IIIB-Ⅳ). 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fruquintinib Combined With Sintilimab and Chemotherapy<br> | Drug: Fruquintinib，Sintilimab，Pemetrexed，Carboplatin<br>* Fruquintinib,fruquintinib at the dose determined in phase safety lead-in,5mg-intermittent (2 weeks on/ 1 week off) ，po，every 3 weeks(q3w) ; Sintilimab at the dose 200mg，iv, d1, given every 3 weeks (q3w); Pemetrexed at the dose 500 mg/m2，iv，d1，given every 3 weeks (q3w); Carboplatin at the dose AUC=4 5，iv，d1；given every 3 weeks (q3w); Maintenance treatment：After 4 6 cycles of carboplatin treatment, Sintilimab 200mg, iv, d1, q3w；Fruquintinib RP2D intermittent(2 weeks on/1 weeks off), po，q3w； pemetrexed 500mg/m2, d1,iv, q3w until progressive disease, death from any cause, unacceptable toxicity or informed consent withdrawal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival (PFS) | To assess the efficacy of Fruquintinib Combined With Chemotherapy as second- | up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) | CR + PR rate according to the RECIST version 1.1 guidelines. | up to 24 months | 
| Disease control rate (DCR) | CR + PR + SD rate according to the RECIST | up to 24 months | 
| Overall Survival（OS） | Overall survival is determined from the date of treatment to death from any cause or the last follow-up date | up to 24 months |