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

NCT ID: NCT05003037

Last Updated: 2022-11-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-08
• Study Completion Date: 2025-04-30

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Wild-type Genotype

Group Type: EXPERIMENTAL

Surufatinib,Toripalimab,Pemetrexed,Carboplatin/Cisplatin

Intervention Type: DRUG

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.

EGFR mutation

Group Type: EXPERIMENTAL

Surufatinib,Toripalimab,Pemetrexed,Carboplatin/Cisplatin

Intervention Type: DRUG

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.

Interventions

Surufatinib,Toripalimab,Pemetrexed,Carboplatin/Cisplatin

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.

Intervention Type: DRUG

Eligibility Criteria

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. At least one lesion can be measured by imaging.

5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.

6. Life expectancy ≥ 12 weeks.

7. None previous chemotherapy or targeted therapy(Arm:wild-type genotype).

8. Patients should be confirmed acquired EGFR T790M mutation and received adequate EGFR-TKI treatment(Arm:EGFR mutation).

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Li Zhang, MD

OTHER

Sponsor Role: lead

Responsible Party

Li Zhang, MD

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wenfeng Fang, MD.

Role: CONTACT

fangwf@sysucc.org.cn

+86-15322302066

Facility Contacts

Wenfeng Fang, MD.

Role: primary

fangwf@sysucc.org.cn

+86-15322302066

Other Identifiers

HMPL-012-SPRING-L102

Identifier Type: -

Identifier Source: org_study_id