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

Carcinoma, Non-Small-Cell Lung Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05003037
• Other study ID #: HMPL-012-SPRING-L102
• Status: Recruiting
• Phase: Phase 2
• Start date: December 8, 2021
• Est. completion date: April 30, 2025

Study information

• Verified date: November 2022
• Source: Sun Yat-sen University
• Contact: Wenfeng Fang, MD.
• Phone: +86-15322302066
• Email: fangwf[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 106
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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-?).

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guang Dong

Sponsors (1)

Lead Sponsor	Collaborator
Li Zhang, MD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS)		up to 24 months
Secondary	Objective response rate(ORR)		up to 24 months
Secondary	Disease control rate(DCR)		up to 24 months
Secondary	Overall Survival(OS)		up to 24 months