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Surufatinib Combined With Toripalimab 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

Surufatinib,Toripalimab,Pemetrexed,Carboplatin/Cisplatin

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).
At least one lesion can be measured by imaging.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
Life expectancy ≥ 12 weeks.
None previous chemotherapy or targeted therapy(Arm:wild-type genotype).
Patients should be confirmed acquired EGFR T790M mutation and received adequate EGFR-TKI treatment(Arm:EGFR mutation).
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

Sun Yat-sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Wild-type Genotype

EGFR mutation

Arm Description

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS)

Secondary Outcome Measures

Objective response rate(ORR)

Disease control rate(DCR)

Overall Survival(OS)

Full Information

NCT ID

NCT05003037

First Posted

August 6, 2021

Last Updated

November 3, 2022

Sponsor

Li Zhang, MD

1. Study Identification

Unique Protocol Identification Number

NCT05003037

Brief Title

Surufatinib Combined With Toripalimab and Chemotherapy in the Treatment of Non-Small Cell Lung Cancer

Official Title

A Open-label, Single Center, Phase II Study of Surufatinib Combined With Toripalimab and Chemotherapy in Patients With Advanced Non-squamous Non-small-cell Lung Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

December 8, 2021 (Actual)

Primary Completion Date

April 30, 2023 (Anticipated)

Study Completion Date

April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Li Zhang, MD

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 Surufatinib Combined With Toripalimab and Chemotherapy as a first-line treatment in patients with advanced 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

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

106 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Wild-type Genotype

Arm Type

Experimental

Arm Title

EGFR mutation

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Surufatinib,Toripalimab,Pemetrexed,Carboplatin/Cisplatin

Intervention Description

Surufatinib at the dose determined in phase safety lead-in，250 mg，qd，po，every 3 weeks(q3w) ; Toripalimab at the dose 240mg，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=5~6，iv，d1，given every 3 weeks (q3w) or Cisplatin at the dose 75 mg/m2，iv ,d1，q3w; Maintenance treatment：After the end of the first-line treatment, patients with CR, PR, and SD can continue to maintenance treatment with Surufatinib RP2D，d1-21，q3w＋Toripalimab 240mg，d1，q3w+Pemetrexed 500mg/m2，d1，q3w was taken until the disease progressed.

Primary Outcome Measure Information:

Title

Progression Free Survival (PFS)

Time Frame

up to 24 months

Secondary Outcome Measure Information:

Title

Objective response rate(ORR)

Time Frame

up to 24 months

Title

Disease control rate(DCR)

Time Frame

up to 24 months

Title

Overall Survival(OS)

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). At least one lesion can be measured by imaging. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1. Life expectancy ≥ 12 weeks. None previous chemotherapy or targeted therapy(Arm:wild-type genotype). Patients should be confirmed acquired EGFR T790M mutation and received adequate EGFR-TKI treatment(Arm:EGFR mutation). 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

Wenfeng Fang, MD.

Phone

+86-15322302066

fangwf@sysucc.org.cn

Facility Information:

Facility Name

Sun Yat-sen University Cancer Center

City

Guangzhou

State/Province

Guang Dong

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wenfeng Fang, MD.

Phone

+86-15322302066

fangwf@sysucc.org.cn

12. IPD Sharing Statement

Learn more about this trial

Surufatinib Combined With Toripalimab and Chemotherapy in the Treatment of Non-Small Cell Lung Cancer

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