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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05003037
Recruitment Status : Recruiting
First Posted : August 12, 2021
Last Update Posted : November 4, 2022
Sponsor:
Information provided by (Responsible Party):
Li Zhang, MD, Sun Yat-sen University

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: Surufatinib,Toripalimab,Pemetrexed,Carboplatin/Cisplatin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 8, 2021
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : April 30, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Wild-type Genotype 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.

Experimental: EGFR mutation 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.




Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: up to 24 months ]

Secondary Outcome Measures :
  1. Objective response rate(ORR) [ Time Frame: up to 24 months ]
  2. Disease control rate(DCR) [ Time Frame: up to 24 months ]
  3. Overall Survival(OS) [ Time Frame: up to 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05003037


Contacts
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Contact: Wenfeng Fang, MD. +86-15322302066 fangwf@sysucc.org.cn

Locations
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China, Guang Dong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guang Dong, China
Contact: Wenfeng Fang, MD.    +86-15322302066    fangwf@sysucc.org.cn   
Sponsors and Collaborators
Li Zhang, MD
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Responsible Party: Li Zhang, MD, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT05003037    
Other Study ID Numbers: HMPL-012-SPRING-L102
First Posted: August 12, 2021    Key Record Dates
Last Update Posted: November 4, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Cisplatin
Carboplatin
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors