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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fruquintinib Combined With Sintilimab and Chemotherapy | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fruquintinib,Sintilimab,Pemetrexed,Carboplatin | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | To assess the efficacy of Fruquintinib Combined With Chemotherapy as second- | up to 24 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongqian Shu, PhD | Contact | 00862568306428 | shuyongqian@csco.org.cn | |
| Pei Ma, M.D. | Contact | 00862568305931 | mapei@jsph.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Province Hospital | Recruiting | Nanjing | Jiangsu | 210029 | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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|
| 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 |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |