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

Primary Purpose

Carcinoma, Non-Small-Cell Lung

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Fruquintinib，Sintilimab，Pemetrexed，Carboplatin

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Jiangsu Province HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fruquintinib Combined With Sintilimab and Chemotherapy

Arm Description

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS)

To assess the efficacy of Fruquintinib Combined With Chemotherapy as second-

Secondary Outcome Measures

Objective response rate (ORR)

CR + PR rate according to the RECIST version 1.1 guidelines.

Disease control rate (DCR)

CR + PR + SD rate according to the RECIST

Overall Survival（OS）

Overall survival is determined from the date of treatment to death from any cause or the last follow-up date

Full Information

NCT ID

NCT04956146

First Posted

June 30, 2021

Last Updated

February 11, 2022

Sponsor

The First Affiliated Hospital with Nanjing Medical University

1. Study Identification

Unique Protocol Identification Number

NCT04956146

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 2, 2022 (Actual)

Primary Completion Date

September 30, 2023 (Anticipated)

Study Completion Date

September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The First Affiliated Hospital with Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Non-Small-Cell Lung

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Fruquintinib Combined With Sintilimab and Chemotherapy

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Fruquintinib，Sintilimab，Pemetrexed，Carboplatin

Intervention Description

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

Primary Outcome Measure Information:

Title

Progression Free Survival (PFS)

Description

To assess the efficacy of Fruquintinib Combined With Chemotherapy as second-

Time Frame

up to 24 months

Secondary Outcome Measure Information:

Title

Objective response rate (ORR)

Description

CR + PR rate according to the RECIST version 1.1 guidelines.

Time Frame

up to 24 months

Title

Disease control rate (DCR)

Description

CR + PR + SD rate according to the RECIST

Time Frame

up to 24 months

Title

Overall Survival（OS）

Description

Overall survival is determined from the date of treatment to death from any cause or the last follow-up date

Time Frame

up to 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yongqian Shu, PhD

Phone

00862568306428

shuyongqian@csco.org.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Pei Ma, M.D.

Phone

00862568305931

mapei@jsph.org.cn

Facility Information:

Facility Name

Jiangsu Province Hospital

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210029

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pei Ma, M.D.

Phone

008668305931

mapei@jsph.org.cn

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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