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Extensive-stage Small-cell Lung CancerPhase 2NCT05668767

Surufatinib in Combination of Durvalumab and EP/EC in the Firstly-line Treatment of ES-SCLC

A Phase 2 study testing Surufatinib Durvalizumab EP/EC in people with Extensive-stage Small-cell Lung Cancer, run by Beijing Chest Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Though great progress has been made in the treatment of SCLC in recent years, only two PD-L1 therapies are currently approved, treatment options are limited, and patient survival remains to be further improved. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Extensive-stage Small-cell Lung Cancer
What is being tested?
Surufatinib Durvalizumab EP/EC
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
Dec 2022to Dec 2025
Phase
Phase 2
Are there results?
None posted in the registry

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

  • age ≥ 18 years;
  • pathohistologically or cytologically confirmed small cell lung cancer with measurable lesions (RECIST 1.1, see Appendix 2);
  • no previous systemic anti-tumor therapy;
  • ECOG 0 or 1 (see Appendix 1);
  • expected survival ≥ 12 weeks;
  • at least one measurable lesion (RECIST 1.1 criteria);
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  • basically normal major organ and bone marrow function: a) blood routine: white blood cells ≥ 4.0 x 109/L, neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, hemoglobin ≥ 90 g/L; b) international normalized ratio (INR) ≤ 1.5 × upper limit of normal (ULN), and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; c) liver function: total bilirubin ≤ 1.5 x ULN; in the absence of liver metastasis, ALT/AST/ALP ≤ 2.5 x ULN; in the presence of liver metastases,ALT/AST/ALP ≤ 5 x ULN; d) renal function: serum creatinine ≤ 1.5 x ULN, and creatinine clearance (CCr) 60 mL/min (see Appendix 6); e) normal cardiac function, left ventricular ejection fraction (LVEF) ≥ 50% by two-dimensional echocardiography.
  • fully understand the study, voluntarily participate, and sign the informed consent form.
  • male or female patients of childbearing potential voluntarily use effective contraceptive methods during the study and within 6 months of the last study medication, such as double-barrier contraceptive methods, condoms, oral or injectable contraceptives, intrauterine devices, etc.All female patients will be considered to be of childbearing potential unless they are naturally postmenopausal, have undergone artificial menopause, or have undergone sterilization (eg, hysterectomy, bilateral adnexectomy, or radiation ovarian irradiation).

Who cannot join

  • previously received systemic anti-tumor therapy for small cell lung cancer;
  • tumors showing significant cavities or necrosis on imaging (CT or MRI)
  • patients with brain or central nervous system metastases, including leptomeningeal disease, or CT/MRI examination suggesting brain or leptomeningeal lesions) (patients with brain metastases within 28 days before the completion of randomized treatment and symptoms from stable enrollment, but brain MRI examination is required, and CT or intravenous angiography confirms no symptoms of cerebral hemorrhage);
  • patients who are participating in other clinical studies within 4 weeks after the end of previous clinical studies (except non-interventional studies);
  • Patients who have received chemotherapy, radiotherapy or other investigational anticancer therapy (except bisphosphonates) within 4 weeks prior to the first dose of this study. Patients who have previously received local radiotherapy are eligible if they meet the following criteria: end of radiotherapy more than 4 weeks from the start of this study (brain radiotherapy more than 2 weeks); in addition, the target lesions selected for this study are not in the radiotherapy area, or if the target lesions are within the radiotherapy area, but progression has been confirmed;
  • Other types of malignancy within 5 years or present;
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  • patients with active, known, or suspected autoimmune diseases, including allogeneic organ transplantation, history of allogeneic hematopoietic stem cell transplantation, history of HIV-positive or history of acquired immunodeficiency syndrome (AIDS);
  • active or previously documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis);
  • non-remitting toxicity from previous treatment, more than CTC AE (4.0) grade 1, excluding alopecia;
  • Abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT ULN > 1.5), with bleeding tendency or receiving thrombolytic and anticoagulant therapy, clinically significant hemoptysis (hemoptysis more than half a tablespoon daily; or clinically significant bleeding symptoms or bleeding tendency within 4 weeks before grouping, such as gastrointestinal bleeding, hemorrhagic gastric ulcer (including gastrointestinal perforation and/or fistula, but gastrointestinal perforation or fistula has been surgically removed, admission is allowed), baseline fecal occult blood + + or more, unhealed wounds, ulcers or fractures;
  • urine routine showed urine protein ≥ + +, or urine protein ≥ 1.0 g within 24 hours;
  • Uncontrolled hypertension (SBP ≥ 160 mmHg and DBP ≥ 100 mmHg despite optimal medical therapy);
  • Patients with severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmia; according to NYHA criteria, grade III-IV cardiac insufficiency, or left ventricular ejection fraction (LVEF) < 50% by echocardiography;
  • Patients with NCI-CTCAE grade II or higher peripheral neuropathy, except due to trauma;
  • Interstitial lung disease, uncontrolled moderate to large serous effusion (including pleural effusion, ascites, and pericardial effusion) after pumping therapy, exacerbation of chronic obstructive pulmonary disease requiring intravenous antibiotics within 28 days, active pulmonary infection, and/or acute bacterial or fungal respiratory disease;
  • There are factors that significantly affect the absorption of oral drugs, such as inability to swallow, chronic diarrhea and intestinal obstruction;
  • Venous thromboembolic events such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis, pulmonary embolism within 6 months prior to enrollment;
  • Has received a live or attenuated vaccine within 30 days prior to the first dose of dulizumab, or plans to receive a live or attenuated vaccine during the study;
  • Known history of severe hypersensitivity to other monoclonal antibodies;
  • Known history of psychotropic drug abuse, alcohol abuse, or drug abuse;
  • Active hepatitis uncontrolled after treatment (hepatitis B: HBsAg positive and HBV DNA more than 1 x 10 ^ 4 copies/ml; hepatitis C: HCV RNA positive and abnormal liver function); combined hepatitis B and C infection;
  • Have other serious diseases that, in the opinion of the investigator, jeopardize the patient 's safety or affect the patient' s completion of the study;

Trial locations and contacts

No sites are listed yet.

Ying Hu contact

010-89509000

huying@bjxkyy.cn

About this study

Official title: Multi-centered, Single-arm, Phase II Study on Surufatinib in Combination of Durvalumab and Etoposide and Carboplatin/Cisplatin in the Firstly-line Treatment of Extensive-stage Small-cell Lung Cancer

Though great progress has been made in the treatment of SCLC in recent years, only two PD-L1 therapies are currently approved, treatment options are limited, and patient survival remains to be further improved. The current study aims to investigate the efficacy and safety of surufatinib combined with durvalumab combined with EP/EC regimen in first-line treatment of patients with extensive-stage SCLC, and to further explore the predictive biomarkers of this treatment combination.

Read the detailed description

BACKGROUND: Small-cell lung cancer (SCLC) is an aggressive neuroendocrine tumor derived from bronchial epithelial cells, accounting for about 13-15% of all lung cancers. It has a rapid doubling time and high growth fraction, and tends to metastasize widely early in the course of the disease, resulting in 95% mortality. It is the most lethal subtype of lung cancer.

Platinum-based chemotherapy is the first-line standard treatment for localized and extensive SCLC, with platinum combined with etoposide as the preferred regimen. However, chemotherapy options are limited and there remains a great unmet need for efficacy.

In recent years, with the development of immunotherapy, chemotherapy combined with immunization has also become the treatment option for treatment-naïve patients, and PD-L1 inhibitor combined with chemotherapy first-line treatment has become a guideline class 1A recommendation; there is a significant benefit in OS compared with chemotherapy: in the IMpower 133 study, atezolizumab combined with EP regimen resulted in an OS of 12.3 months; in the CASPIAN study, Durvalumab combined with EP/EC regimen resulted in an OS of 13 months.

An increasing number of targeted therapeutics have also been newly explored in the field of SCLC. In first-line treatment, PFS reached 9.6 months, OS reached 13.87 months, and ORR reached 77.8% with anlotinib in combination with EP/EC regimen.

Though great progress has been made in the treatment of SCLC in recent years, only two PD-L1 therapies are currently approved, treatment options are limited, and patient survival remains to be further improved. The current study aims to investigate the efficacy and safety of surufatinib combined with durvalumab combined with EP/EC regimen in first-line treatment of patients with extensive-stage SCLC, and to further explore the predictive biomarkers of this treatment combination.

Being tested
Surufatinib Durvalizumab EP/EC
Keywords
SCLC
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.

  • Surufatinib Durvalizumab EP/ECDrug

    Also called HMPL-012

    Etoposide: total 100 mg/m2, once a day, continuous intravenous drip for more than 3 hours, days 1 to 3, q3w Cisplatin: total 75 mg/m2, once a day, continuous intravenous drip for more than 3 hours, days 1 to 3, q3w; or Carboplatin: AUC 5-6, intravenous infusion, administered on day 1 of each treatment cycle, q3w

Study groups in NCT05668767
Study groupRoleWhat they receive
study groupExperimentalSingle-arm Surufatinib Durvalumab EP/EC
Receives: Drug: Surufatinib Durvalizumab EP/EC

What is being measured

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

  1. Progress Free Survival(PFS)

    assessed by the investigator as per the Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)

    Measured: up to 24 months

Secondary outcomes (5)

  1. Overall survival

    Overall survival (OS)

    Measured: About 18 months

  2. Objective response rate

    Objective response rate (ORR) assessed per RECIST v1.1

    Measured: About 18 months

  3. Disease control rate

    Disease control rate (DCR) assessed per RECIST v1.1

    Measured: About 18 months

  4. Quality of Life

    EORCT-QLQ-LC13 Scale

    Measured: About 18 months

  5. Incidence of adverse events

    The incidence of adverse events of all grades

    Measured: From Baseline to primary completion date, about 18 months

Timeline

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

  1. First posted30 Dec 2022
  2. Study startDec 2022 (estimated)
  3. Primary completionDec 2023 (estimated)
  4. Study completionDec 2025 (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
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05668767
Sponsor's protocol ID
HMPL-012-N1-SCLC107
Status last verified
Dec 2022
First submitted
20 Dec 2022
Last updated
30 Dec 2022
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 Durvalizumab EP/EC in people with Extensive-stage Small-cell Lung Cancer, run by Beijing Chest Hospital.

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 9 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 30 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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

Contact Ying Hu (010-89509000, huying@bjxkyy.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progress Free Survival(PFS) (time frame: 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 NCT05668767.

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 30 Dec 2022.

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