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ToripalimabPhase 2NCT06719700

Concurrent Chemoradiotherapy Combined With Toripalimab and Surufatinib in the Treatment of Limited-Stage Small Cell Lung Cancer

A Phase 2 study testing Chemotherapy, Immunotherapy and Angio-immuno kinase inhibitor in people with Toripalimab and Surufatinib, run by Sun Yat-sen University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Based on the preclinical rationale for combining surufatinib with immunotherapy, and the clinical efficacy observed with surufatinib in extensive-stage small cell lung cancer (ES-SCLC), the investigators hypothesize that incorporating surufatinib into the ADRIATIC regimen could further enhance survival in LS-SCLC. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Toripalimab, Surufatinib, Chemoradiotherapy
What is being tested?
Chemotherapy, Immunotherapy and Angio-immuno kinase inhibitor
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
1 siteChina
Study dates
30 Nov 2024to 29 Nov 2028
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Informed Consent: An informed consent form, signed and dated, must be provided before any steps in the study are performed.
  • Age: Males or females aged 18 to 75 years.
  • Diagnosis: Histologically or cytologically confirmed small cell lung cancer (SCLC).
  • Stage: Stage I-III (AJCC/UICC 8th edition TNM staging), where all lesions can be included in a single radical radiotherapy plan (i.e., limited-stage disease). Stage I-II must be inoperable.
  • Life Expectancy: ≥12 weeks.
  • Performance Status (PS): WHO PS score of 0 or 1.
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  • Postmenopausal women or those with a negative urine or serum pregnancy test (HCG sensitivity ≥25 IU/L or equivalent) within 7 days before starting study treatment.
  • Female participants must not be breastfeeding.
  • Women of childbearing potential (WOCBP) must agree to use contraception during study treatment and for 3 months after the last dose of study drug (i.e., 30 days for an ovulation cycle plus approximately 5 half-lives of the investigational drug).
  • Male participants engaging in sexual activity with WOCBP must agree to use contraception during study treatment and for 5 months after the last dose of study drug (i.e., 90 days for sperm regeneration cycle plus approximately 5 half-lives of the investigational drug).
  • Males with azoospermia do not need to follow contraception requirements.
  • WOCBP who are not sexually active do not need to follow contraception requirements but must still undergo pregnancy testing as outlined.
  • Organ and Bone Marrow Function:
  • Pulmonary Function: FEV1 ≥800 mL. Absolute neutrophil count ≥1.5 × 10⁹/L. Platelet count ≥100 × 10⁹/L. Hemoglobin ≥9.0 g/dL. Renal Function: Calculated creatinine clearance ≥50 mL/min using the Cockcroft-Gault formula.
  • Serum bilirubin ≤1.5 × upper limit of normal (ULN). AST and ALT ≤2.5 × ULN.

Who cannot join

  • Participation in Another Clinical Trial: Simultaneous participation in another clinical trial, unless it is an observational (non-interventional) study.
  • Mixed Histology: Histological subtype of mixed small cell and non-small cell lung cancer (SCLC).
  • Extensive-Stage SCLC: Diagnosis of extensive-stage SCLC.
  • Malignant Effusions: Pathologically confirmed malignant pleural effusion or pericardial effusion.
  • Hemoptysis: Central cavitary SCLC with hemoptysis (hemoptysis volume >50 ml/day).
  • Immunosuppressive Treatment: Use of immunosuppressive drugs within 28 days prior to the first dose of toripalimab. Physiological doses of intranasal corticosteroids and systemic corticosteroids ≤10 mg daily of prednisone (or equivalent) are exceptions. Steroids used to manage chemoradiotherapy-related toxicities are allowed.
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  • Previous Anti-PD-1/PD-L1 Therapy: Prior use of any anti-PD-1 or anti-PD-L1 antibodies.
  • Major Surgery: Underwent major surgery (excluding vascular access) within 4 weeks before study entry.
  • Autoimmune Disease History: History of autoimmune diseases within the last 2 years, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis.
  • Primary Immunodeficiency: History of primary immunodeficiency.
  • Organ Transplant History: History of organ transplantation requiring immunosuppressive treatment.
  • QT Interval Prolongation: QTc interval (corrected by Bazett's formula) >470 ms, calculated from three ECG measurements.
  • Uncontrolled Comorbidities: Uncontrolled comorbid conditions, including but not limited to persistent or active infections, symptomatic congestive heart failure, poorly controlled hypertension, unstable angina, arrhythmias, active peptic ulcer disease or gastritis, active bleeding disorders, chronic hepatitis C, HIV infection, HBsAg-positive patients with DNA >500 IU/ml, or any psychiatric or social conditions that may interfere with study requirements or the patient's ability to provide informed consent.
  • Tuberculosis History: Known history of tuberculosis.
  • Live Vaccination: Received a live attenuated vaccine within 30 days prior to study initiation.
  • Previous Primary Malignancy: History of another primary malignancy within 5 years prior to study entry, except for adequately treated basal or squamous cell carcinoma of the skin, in situ cervical cancer, ductal carcinoma in situ of the breast, or localized prostate cancer.
  • Pregnancy and Breastfeeding: Pregnant or breastfeeding women, or men and women of reproductive potential who are not using effective contraception.
  • Interference with Study Assessment: Any condition that may interfere with the evaluation of toripalimab's efficacy or safety.
  • Investigator's Discretion: Any other condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Bo Qiu, Professor contact

+862087343031

qiubo@sysucc.org.cn

Hui Liu, Professor contact

+862087343031

liuhui@sysucc.org.cn

China1 site, 1 recruiting
  • Sun yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Hui Liu, MD, +86-020-87343031, liuhuisysucc@126.com

    Recruiting

Other trials in China

About this study

Official title: A Prospective Phase II Study of Concurrent Chemoradiotherapy Combined With Toripalimab and Surufatinib in the Treatment of Limited-Stage Small Cell Lung Cancer

Based on the preclinical rationale for combining surufatinib with immunotherapy, and the clinical efficacy observed with surufatinib in extensive-stage small cell lung cancer (ES-SCLC), the investigators hypothesize that incorporating surufatinib into the ADRIATIC regimen could further enhance survival in LS-SCLC. To evaluate this approach, the investigators plan to conduct a single-arm Phase II study to explore the safety and efficacy of concurrent chemoradiotherapy combined with toripalimab and surufatinib in treating LS-SCLC.

Read the detailed description

This single-arm Phase II study aims to explore the safety and efficacy of concurrent chemoradiotherapy combined with toripalimab and surufatinib in treating LS-SCLC. In this single-arm, Phase II study, patients are planned to receive four cycles of etoposide combined with either cisplatin or carboplatin, along with toripalimab and surufatinib. During chemotherapy, patients will undergo concurrent radiotherapy. Following chemoradiotherapy, consolidation treatment with toripalimab and surufatinib will be administered. Prophylactic cranial irradiation (PCI) is recommended prior to the consolidation therapy.

Being tested
Chemotherapy, Immunotherapy, Angio-immuno kinase inhibitor, radiotherapy, Prophylactic Cranial Irradiation
Keywords
Toripalimab, Surufatinib, Chemoradiotherapy, Limited-stage small cell lung cancer (LS-SCLC), Immunotherapy consolidation
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

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

  • ChemotherapyDrug

    Etoposide combined with cisplatin or carboplatin, administered every three weeks for a total of four cycles.

  • ImmunotherapyDrug

    Toripalimab was administered concurrently with chemotherapy, every three weeks for four cycles.

  • Angio-immuno kinase inhibitorDrug

    Oral surufatinib 200 mg once daily (q.d.), given on days 1-14 of each chemotherapy cycle.

  • radiotherapyRadiation

    Thoracic radiotherapy will begin no later than the start of the third chemotherapy cycle.

  • Prophylactic Cranial IrradiationRadiation

    PCI is recommended after the completion of chemoradiotherapy.

  • Consolidation Therapy with Toripalimab and SurufatinibDrug

    Patients achieving complete response (CR), partial response (PR), or stable disease (SD) following chemoradiotherapy will receive consolidation therapy. Toripalimab: 240 mg intravenously on day 1, every three weeks. Surufatinib: 200 mg orally on days 1-14, every three weeks.

Study groups in NCT06719700
Study groupRoleWhat they receive
The study groupExperimentalIn this single-arm, patients are planned to receive four cycles of etoposide combined with either cisplatin or carboplatin, along with toripalimab and surufatinib. During chemotherapy, patients will undergo concurrent radiotherapy. Following chemoradiotherapy, consolidation treatment with toripalimab and surufatinib will be administered. Prophylactic cranial irradiation (PCI) is recommended prior to the initiation of immunotherapy consolidation.
Receives: Drug: Chemotherapy; Drug: Immunotherapy; Drug: Angio-immuno kinase inhibitor; Radiation: radiotherapy; Radiation: Prophylactic Cranial Irradiation; Drug: Consolidation Therapy with Toripalimab and Surufatinib

What is being measured

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

  1. Median progression-free survival (PFS)

    The length of time from the start of treatment until disease progression or death from any cause, whichever occurs first.

    Measured: 2 years

Secondary outcomes (3)
  1. Median overall survival (OS)

    The time from the start of treatment to death from any cause.

    Measured: 2 years

  2. Treatment-related adverse events

    The assessment of treatment-related adverse events (AEs), including their type, severity, frequency, and impact on patients.

    Measured: 1 year after treatment

  3. Patient-Reported Outcomes

    Patient reported quality of life measured by European organization for Research and Treatment of Cancer (EORTC) Quality of Life Core 30 (QLQ-C30) and QLQ-LC13.

    Measured: 1 year after treatment

Timeline

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

  1. First posted6 Dec 2024
  2. Study start30 Nov 2024
  3. Primary completion29 Nov 2028 (estimated)
  4. Study completion29 Nov 2028 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
47 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06719700
Sponsor's protocol ID
GASTO-10123
Status last verified
Feb 2026
First submitted
3 Dec 2024
Last updated
3 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhang Y, Huang Y, Yang Y, Zhao Y, Zhou T, Chen G, Zhao S, Zhou H, Ma Y, Hong S, Zhao H, Zhang L, Fang W. Surufatinib plus toripalimab combined with etoposide and cisplatin as first-line treatment in advanced small-cell lung cancer patients: a phase Ib/II trial. Signal Transduct Target Ther. 2024 Sep 27;9(1):255. doi: 10.1038/s41392-024-01974-2.

    PubMed 39327433
  • Li, X. et al. Enhanced anticancer efficacy via ROS-dependent ferroptosis: Synergy between surufatinib and cisplatin in small cell lung cancer. Cancer Res 84(6_Supplement), 2122 (2024)

  • Zhou, J. et al. Preclinical evaluation of sulfatinib, a novel angio-immuno kinase inhibitor targeting VEGFR, FGFR-1 and CSF-1R kinases. AACR 77, abs 4187 (2017)

  • David R. Spigel et al., ADRIATIC: Durvalumab (D) as consolidation treatment (tx) for patients (pts) with limited-stage small-cell lung cancer (LS-SCLC). JCO 42, LBA5-LBA5(2024).

  • Senan S, Okamoto I, Lee GW, Chen Y, Niho S, Mak G, Yao W, Shire N, Jiang H, Cho BC. Design and Rationale for a Phase III, Randomized, Placebo-controlled Trial of Durvalumab With or Without Tremelimumab After Concurrent Chemoradiotherapy for Patients With Limited-stage Small-cell Lung Cancer: The ADRIATIC Study. Clin Lung Cancer. 2020 Mar;21(2):e84-e88. doi: 10.1016/j.cllc.2019.12.006. Epub 2019 Dec 28.

    PubMed 31948903
  • Takada M, Fukuoka M, Kawahara M, Sugiura T, Yokoyama A, Yokota S, Nishiwaki Y, Watanabe K, Noda K, Tamura T, Fukuda H, Saijo N. Phase III study of concurrent versus sequential thoracic radiotherapy in combination with cisplatin and etoposide for limited-stage small-cell lung cancer: results of the Japan Clinical Oncology Group Study 9104. J Clin Oncol. 2002 Jul 15;20(14):3054-60. doi: 10.1200/JCO.2002.12.071.

    PubMed 12118018
  • Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

    PubMed 30207593

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Chemotherapy, Immunotherapy and Angio-immuno kinase inhibitor in people with Toripalimab and Surufatinib, run by Sun Yat-sen University 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 15 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 3 Mar 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?

Contact Bo Qiu, Professor (+862087343031, qiubo@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Median progression-free survival (PFS) (time frame: 2 years). 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 NCT06719700, which also lists 7 linked publications.

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 3 Mar 2026.

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