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

NCT05003037 | Active Not Recruiting 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 in patients with advanced non-squamous non-small cell lung cancer.

Conditions

Non Small Cell Lung Cancer

Keywords

Surufatinib; toripalimab; NSCLC

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to 24 months)

Secondary Outcomes (5)

• Objective response rate(ORR)

  From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to 24 months)

• Disease control rate(DCR)

  From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to 24 months)

• Overall Survival(OS)

  From date of first dose of study drug until withdrawal of consent or death (up to 36 months)

• 12-month PFS rate

  From date of first dose of study drug until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

• Number of patients suffering adverse events (CTCAE 5.0)

  From date of signing the informed consent form until survival follow-up or initiation of new anti-tumor therapies (up to 36 months).

Study Arms (2)

Patients without targetable driver mutations

EXPERIMENTAL

Patients with advanced non-squamous NSCLC negative for canonical driver genes except KRAS

Drug: Surufatinib, Toripalimab, Pemetrexed, Carboplatin/Cisplatin

Patients with targetable driver mutations

EXPERIMENTAL

Patients with advanced non-squamous NSCLC harboring actionable genomic alterations

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, q3w; Pemetrexed at the dose 500 mg/m2, iv, d1, q3w; Carboplatin at the dose AUC=5\~6, iv, d1, 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 + Toripalimab 240mg, d1, q3w + Pemetrexed 500mg/m2, d1, q3w. Treatment continues until disease progression, death, or intolerable toxicity occurs.

Patients with targetable driver mutations; Patients without targetable driver mutations

Eligibility Criteria

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

You may qualify if:

• Fully informed about the study and voluntary signing of the informed consent form;
• Age ≥18 years, male or female;
• Patients with histologically or cytologically confirmed unresectable or intolerant to definitive chemoradiotherapy stage IIIB/IV non-squamous non-small cell lung cancer (NSCLC);
• ECOG PS score of 0-1;
• Expected survival ≥12 weeks;
• Patients must have at least one measurable lesion (according to RECIST 1.1);
• Prior to enrollment, the patient must be confirmed to carry one of the following driver gene mutations, including but not limited to: EGFR mutation, ALK fusion, ROS1 and RET fusion; BRAF mutation, ERBB2 (HER2) amplification/mutation, MET amplification, MET exon 14 skipping mutation, and NTRK fusion. Patients with KRAS mutations are not permitted (assigned to Cohort 2). EGFR mutation cases are not expected to exceed 50% of all enrolled patients in Cohort 2.
• Patients with driver gene mutations in Cohort 2 are required to have received adequate tyrosine kinase inhibitor (TKI) therapy, as follows:
• EGFR mutant patients: 1) Patients who have received first-or second-generation epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) as first-line therapy and do not exhibit T790M mutation resistance; 2) Patients with T790M mutations are required to receive third-generation EGFR-TKIs; 3) Patients who have progressed after third-generation EGFR-TKIs therapy.
• ALK fusion-positive patients: Progression or intolerance on first-line therapy for ALK fusion-positive NSCLC;
• For ROS1 fusion-positive patients: Progression or intolerance on first-line therapy for ROS1 fusion-positive NSCLC;
• Patients with other driver gene mutations currently lacking standard first-line treatment are not forced to receive prior systematic treatment;
• Patients with a history of bevacizumab use and/or multi-target small molecule anti-tumor angiogenesis tyrosine kinase inhibitors are permitted in cohort 2;
• Patients with normal organ function prior to enrollment, meeting the following criteria:
• \) Hematology testing:

You may not qualify if:

• Patients having received immunotherapy for tumors (such as PD-1, PD-L1) prior to enrollment, excluding those who received definitive systemic treatment for recurrent or metastatic disease within 6 months after completion of curative therapy.
• History of severe hypersensitivity reactions to other monoclonal antibody administration.
• Patients with small cell lung cancer, including mixture of small cell and non-small cell lung cancer.
• Central-type, cavitary pulmonary squamous cell carcinoma, or non-small cell lung cancer with hemoptysis (\>50 mL/day).
• Presence of symptomatic or clinically significant thyroid dysfunction during screening (hypothyroidism that can be controlled by thyroid hormone replacement therapy is eligible).
• Diagnosed with immunodeficiency, or currently receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy (dose \>10 mg/day prednisone or other equivalent potency), and still on treatment within 2 weeks prior to first dose.
• Active autoimmune disease requiring systemic therapy (such as disease-modifying medications, corticosteroids, or immunosuppressants) within 2 years prior to enrollment, including but not limited to: autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, nephritis; subjects requiring medical intervention with bronchodilators for asthma are excluded. Replacement therapies (e.g., thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered systemic treatments;
• Receipt of prophylactic vaccines or live attenuated vaccines within 4 weeks prior to enrollment;
• Receipt of any approved or investigational systemic anti-tumor therapy (including chemotherapy, definitive radiotherapy, biological/immunotherapy, targeted therapy, etc.) within 5 elimination half-lives (if 5 half-lives exceed 21 days, then within 21 days) prior to enrollment;
• Participation in other clinical trials of drugs not yet approved or marketed in China, and receipt of investigational drug treatment within 5 elimination half-lives (if 5 half-lives exceed 21 days, then within 21 days) prior to enrollment.
• Receipt of major surgery or presence of unhealed wounds, ulcers, or fractures within 4 weeks prior to enrollment.
• Uncontrollable malignant ascites (uncontrollable by diuretics or paracentesis, as judged by the investigator).
• International Normalized Ratio (INR) \>1.5 or Activated Partial Thromboplastin Time (APTT) \>1.5×ULN.
• Patients with hypertension that is uncontrolled by medication, defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg (except for those whose blood pressure can be controlled by dual antihypertensive medications prior to enrollment).
• Patients unable to take surufatinib orally;

Sponsors & Collaborators

• Li Zhang, MD: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

surufatinib; toripalimab; Pemetrexed; Carboplatin; Cisplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

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: Principal Investigator

Study Record Dates

• First Submitted: August 6, 2021
• First Posted: August 12, 2021
• Study Start: January 6, 2022
• Primary Completion: November 3, 2025
• Study Completion (Estimated): November 3, 2027
• Last Updated: July 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)