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

NCT05003037 | Unknown Phase 2

• 1 other identifier: HMPL-012-SPRING-L102
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  up to 24 months

Secondary Outcomes (3)

• Objective response rate(ORR)

  up to 24 months

• Disease control rate(DCR)

  up to 24 months

• Overall Survival(OS)

  up to 24 months

Study Arms (2)

Wild-type Genotype

EXPERIMENTAL

Drug: Surufatinib,Toripalimab,Pemetrexed,Carboplatin/Cisplatin

EGFR mutation

EXPERIMENTAL

Drug: Surufatinib,Toripalimab,Pemetrexed,Carboplatin/Cisplatin

Interventions

Surufatinib,Toripalimab,Pemetrexed,Carboplatin/Cisplatin 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; Wild-type Genotype

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Li Zhang, MD: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

surufatinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Wenfeng Fang, MD.

CONTACT

+86-15322302066; fangwf@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 6, 2021
• First Posted: August 12, 2021
• Study Start: December 8, 2021
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2025
• Last Updated: November 4, 2022

Record last verified: 2022-11

Locations

CN (1)