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

Sponsor

The First Affiliated Hospital with Nanjing Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04956146

Collaborator

(none)

Enrollment

Location

Arm

31.9

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Non-Small-Cell Lung	Drug: Fruquintinib，Sintilimab，Pemetrexed，Carboplatin	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

46 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 2, 2022

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Sep 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fruquintinib Combined With Sintilimab and Chemotherapy	Drug: Fruquintinib，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

Arm

Intervention/Treatment

Experimental: Fruquintinib Combined With Sintilimab and Chemotherapy

Drug: Fruquintinib，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

Outcome Measures

Primary Outcome Measures

Progression Free Survival (PFS) [up to 24 months]
To assess the efficacy of Fruquintinib Combined With Chemotherapy as second-

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jiangsu Province Hospital	Nanjing	Jiangsu	China	210029

Sponsors and Collaborators

The First Affiliated Hospital with Nanjing Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The First Affiliated Hospital with Nanjing Medical University

ClinicalTrials.gov Identifier:

NCT04956146

Other Study ID Numbers:

HMPL-013-FLAG-L101

First Posted:

Jul 9, 2021

Last Update Posted:

Mar 2, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung

Carboplatin

Pemetrexed

Study Results

No Results Posted as of Mar 2, 2022