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

Phase 2

Recruiting

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: Surufatinib,Toripalimab,Pemetrexed,Carboplatin/Cisplatin

• Registration Number: NCT05003037
• Lead Sponsor: Li Zhang, MD

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-06
• Study First Submitted QC: 2021-08-06
• Study First Posted: 2021-08-12
• Study Start: 2021-12-08
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-03
• Last Update Posted: 2022-11-04
• Primary Completion: 2023-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 106

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wild-type Genotype	Surufatinib,Toripalimab,Pemetrexed,Carboplatin/Cisplatin	-
EGFR mutation	Surufatinib,Toripalimab,Pemetrexed,Carboplatin/Cisplatin	-

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	up to 24 months

Secondary Outcome Measures

Name	Time	Method
Objective response rate(ORR)	up to 24 months
Disease control rate(DCR)	up to 24 months
Overall Survival(OS)	up to 24 months

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guang Dong, China