Carcinoma, Non-Small-Cell Lung
Conditions
Brief 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.
Interventions
DRUGFruquintinib，Sintilimab，Pemetrexed，Carboplatin
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
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | up to 24 months | To assess the efficacy of Fruquintinib Combined With Chemotherapy as second- |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | up to 24 months | CR + PR rate according to the RECIST version 1.1 guidelines. |
| Disease control rate (DCR) | up to 24 months | CR + PR + SD rate according to the RECIST |
| Overall Survival（OS） | up to 24 months | Overall survival is determined from the date of treatment to death from any cause or the last follow-up date |
Countries
China
Contacts
Primary ContactYongqian Shu, PhD
Backup ContactPei Ma, M.D.
Outcome results
None listed