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Non Small Cell Lung CancerPhase 2NCT05003037

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

A Phase 2 study testing Surufatinib, Toripalimab, Pemetrexed, Carboplatin/Cisplatin in people with Non Small Cell Lung Cancer, run by Li Zhang, MD at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
Surufatinib, Toripalimab, Pemetrexed, Carboplatin/Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
1 siteChina
Study dates
6 Jan 2022to 3 Nov 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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);
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  • Prior to enrollment, patients are required to undergo testing of detectable specimens to confirm a pan-driver gene (including but not limited to EGFR mutation, ALK fusion, ROS1 and RET fusion; BRAF mutation, ERBB2 [also known as HER2] amplification/mutation, MET amplification, MET exon 14 skipping mutation, as well as NTRK fusion and related mutations) wild-type status. Additionally, these patients must not have received any prior systemic therapy regarding advanced non-small cell lung cancer (NSCLC). Patients with KRAS mutations are eligible for inclusion (assigned to Cohort 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:
  • 1) Hematology testing:
  • a)Hemoglobin (HB) ≥90 g/L; b)Absolute neutrophil count (ANC) ≥1.5×109/L; c)Platelet count (PLT) ≥80×109/L. 2) Biochemical test results meeting the following criteria:
  • Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN);
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times of the ULN; in cases of hepatic metastasis, ALT and AST ≤5 times of the ULN.
  • Serum creatinine (Cr) ≤1.5 times of ULN or Creatinine clearance rate (CCr) ≥60 mL/min.
  • 3) Left ventricular ejection fraction (LVEF) ≥ 50%; 4) Urinalysis showing urine protein <3+ or 24-hour urine protein quantification <3.0g.
  • 11. Male or female patients of reproductive potential voluntarily agree to use effective contraception during the study and for 6 months after the last administration, such as dual barrier methods, condoms, oral or injectable contraceptives, intrauterine devices, etc. All female patients shall be considered to have reproductive potential unless they have undergone natural or surgical sterilization (e.g., hysterectomy, bilateral adnexectomy, or radiation therapy, etc.).

Who cannot join

  • 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.
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  • 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;
  • Current gastrointestinal diseases such as active gastric or duodenal ulcer, ulcerative colitis, or active lesions of unresected tumors, or other investigator-judged conditions that may cause gastrointestinal bleeding or perforation;
  • Patients with evidence or history of significant hemorrhagic tendency within 3 months prior to enrollment (>30 mL within 3 months, occurrence of hematemesis, melena, or hematochezia), hemoptysis (>5 mL of fresh blood within 4 weeks), or thromboembolic events within 12 months (including stroke and/or transient ischemic attack).
  • Patients with grade ≥1 myocardial ischemia, myocardial infarction, or severe arrhythmias (including QTc ≥450 ms in males, QTc ≥470 ms in females), and grade ≥1 heart failure (New York Heart Association classification).
  • Past or concurrent untreated malignancies other than the current disease within 5 years.
  • Active or uncontrolled severe infection (≥Grade 2 infection according to CTCAE v5.0 [Common Terminology Criteria for Adverse Events, version 5.0]).
  • Known human immunodeficiency virus (HIV) infection; known clinically significant liver disease history, including viral hepatitis [known hepatitis B virus (HBV) carriers must be excluded if active HBV infection exists, that is, HBV DNA positive (>1×104copies/mL or >2000 IU/mL); known hepatitis C virus (HCV) infection and HCV RNA positive (>1×103 copies/mL), or other hepatitis or cirrhosis] (excluding patients who have normalized related test results after prior antiviral therapy).
  • Presence of unstable or symptomatic brain metastases.
  • Unresolved toxicity higher than Grade 1 per CTCAE v5.0 caused by any prior anticancer therapy, excluding alopecia and ≤Grade 2 neurotoxicity caused by oxaliplatin.
  • Pregnancy (positive pre-treatment pregnancy test) or currently lactating female subjects.
  • Receipt of brachytherapy (implantation of radioactive seeds) within 60 days prior to enrollment.
  • Any other disease, clinically significant metabolic abnormalities, abnormal physical examination, or laboratory abnormalities, which, in the judgment of the investigator, may indicate an unfit condition for investigational drug use (e.g., active epilepsy requiring treatment), may affect the interpretation of study results, or place the patient at high risk.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong

Other trials in China

About this study

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

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.

Being tested
Surufatinib, Toripalimab, Pemetrexed, Carboplatin/Cisplatin
Keywords
Surufatinib, toripalimab, NSCLC
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Surufatinib, Toripalimab, Pemetrexed, Carboplatin/CisplatinDrug

    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.

Study groups in NCT05003037
Study groupRoleWhat they receive
Patients without targetable driver mutationsExperimentalPatients with advanced non-squamous NSCLC negative for canonical driver genes except KRAS
Receives: Drug: Surufatinib, Toripalimab, Pemetrexed, Carboplatin/Cisplatin
Patients with targetable driver mutationsExperimentalPatients with advanced non-squamous NSCLC harboring actionable genomic alterations
Receives: Drug: Surufatinib, Toripalimab, Pemetrexed, Carboplatin/Cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS)

    Measured: 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)

  1. Objective response rate(ORR)

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

  2. Disease control rate(DCR)

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

  3. Overall Survival(OS)

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

  4. 12-month PFS rate

    Measured: 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

  5. Number of patients suffering adverse events (CTCAE 5.0)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2021
  2. Study start6 Jan 2022
  3. Primary completion3 Nov 2025
  4. Study completion3 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
106 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05003037
Sponsor's protocol ID
HMPL-012-SPRING-L102
Status last verified
Jun 2026
First submitted
6 Aug 2021
Last updated
8 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Surufatinib, Toripalimab, Pemetrexed, Carboplatin/Cisplatin in people with Non Small Cell Lung Cancer, run by Li Zhang, MD at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to 24 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05003037.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.

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