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CarcinomaPhase 2NCT04124731

Combination Therapy of Sintilimab and Anlotinib as a First-line Treatment in Advanced NSCLC (SUNRISE)

A Phase 2 study testing sintilimab plus anlotinib and Chemotherapy in people with Carcinoma and Non-small Cell Lung Cancer, run by Shanghai 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is an open label, multi-center, randomized control phase II trial, to compare the efficacy and safety of sintilimab combined with anlotinib versus standard platinum-based chemotherapy as a first-line treatment in advanced NSCLC patients without driven-gene mutations. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Carcinoma, Non-small Cell Lung Cancer
What is being tested?
sintilimab plus anlotinib and Chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
98 participants
Where
No sites listed yet
Study dates
Oct 2019to Apr 2022
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed written informed consent before initiation of any study procedures
  • Age ≥ 18 years and ≤ 75 years
  • Histologically or cytologically confirmed NSCLC, with unresectable local advanced or metastatic disease (stage IIIB-IV according to NSCLC staging version 8)
  • Epidermal Growth Factor Receptor (EGFR)/ Anaplastic Lymphoma Kinase (ALK) wild type non-small cell lung cancer
  • Sufficient qualified tumor tissue or Paraffin-embedded slides are provided to detect the expression of PD-L1 (TPS, 22C3 antibody).
  • At least 1 measurable disease according toRECIST 1.1
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  • None previous chemotherapy or targeted therapy. Adjuvant chemotherapy, neoadjuvant chemotherapy or neoadjuvant chemotherapy plus adjuvant were assessed for eligibility, and the last treatment time must be more than 6 months before enrollment
  • Expected survival over 3 months
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Brain metastasis patients with no symptoms or stable symptoms after local treatment are eligible, provided they meet all of the following conditions:
  • 1) measurable lesions outside the central nervous system 2) no central nervous system symptoms or no aggravation of symptoms for at least 2 weeks 3) patients who did not require glucocorticoid therapy or who discontinued glucocorticoid therapy within 3 days before the first study drug administration 11. Patients are allowed to receive palliative radiotherapy (including craniocerebral radiotherapy for symptomatic brain metastases) at least 1 week prior to enrollment and return to less than or equal to 1 degree of radiosurgery toxicity (CTCAE 5.0, excluding alopecia).
  • 12. Adequate hematologic and organ function defined by the following laboratory results obtained within 14 days prior to randomization: 13. For female patients of childbearing age, a urine or serum pregnancy test should be administered within 3 days prior to the first study drug administration (day 1 of cycle 1) and results should be negative. If a urine pregnancy test does not confirm a negative result, a blood pregnancy test is required. Non-childbearing female were defined as those who had been postmenopausal for at least 1 year or who had undergone surgical sterilization or hysterectomy.
  • 14. If pregnancy is potential, all patients (male and female) are required to use contraception with an annual failure rate of less than 1% for the entire treatment period up to 120 days after the last study drug administration (or 180 days after the last chemotherapy drug administration).

Who cannot join

  • Squamous cell carcinoma (including adenosquamous carcinoma); Small cell lung cancer (including small cell cancer and non-small cell mixed lung cancer).
  • Patients with cavernous squamous cell carcinoma or imaging suggesting infiltration/invasion of large blood vessels or other high bleeding risk factors evaluated by the investigators.
  • Active hemoptysis within 2 weeks before first drug administration (at least 1/2 teaspoon blood spilt at one time);
  • Received radiotherapy before administration of the first study drug, which met one of the following conditions:
  • 1) ≥30% of bone marrow had received radiotherapy within 14 days before treatment 2) received radiotherapy for lung lesions within 6 weeks before treatment with >30Gy dose (enrolled subjects must recover from the toxicity of previous radiotherapy to level 1 or below, do not need glucocorticoid treatment and have no history of radiation pneumonia) 3) the end time of palliative radiotherapy should be within 7 days before the first study drug administration 5. Major surgical treatment within 3 weeks of the first study drug administration (except for biopsy surgery) 6. Have Participated in other clinical studies or less than 4 weeks before the end of treatment in the previous clinical study 7. Previously diagnosis as other malignant tumors within 5 years prior to the first dose of study treatment, with the exception of: skin basal cell carcinoma or squamous cell carcinoma with radical treatment, and/or carcinoma in situ underwent radical resection 8. Prior treatment with PD-1 inhibitor, PD-L1 inhibitor, CTLA4 inhibitor, or anti- angiogenic treatment.
  • 9. A history of active autoimmune disease requiring systemic treatment (e.g. using drugs for disease remission, corticosteroids or immunosuppressor) within 2 years prior to the first dose of study treatment. Substitution therapy (e.g. thyroxine, insulin or physiological corticosteroids for treating adrenal or pituitary dysfunction) is not considered as a systemic treatment.
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  • 10. Received a traditional Chinese medicine with anti-tumor effect, or an immunomodulatory drug (thymosin, interferon, interleukin) within 2 weeks before the first dose, or received major surgery within 3 weeks before the first dose 11. Systemic steroid therapy or any other form of immunosuppressive therapy performed within 7 days prior to the first dose of study (physiologic dose is allowed).
  • 12. The presence of clinically uncontrollable pleural effusion/peritoneal effusion 13. Have received a physical organ or blood system transplant 14. allergic to the active ingredients or excipients of the drugs studied, such as sintilimab, pemetrexed, gemcitabine, carboplatin, cisplatin, etc.
  • 15. Patients with multiple factors that affect oral medications (such as inability to swallow, gastrointestinal resection, chronic diarrhea, and intestinal obstruction) 16. Patients with bleeding tendencies (such as active gastrointestinal ulcers) or treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues; Small doses of warfarin (≤1mg/d), small doses of heparin (≤ 12,000 U/d) or small doses of aspirin (≤100mg/d) are allowed for prophylactic purposes, provided that the international standardized ratio of prothrombin time (INR) ≤1.5 17. Patients with severe arteriovenous thrombosis, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis and pulmonary embolism, which occurred within 6 months before the first treatment 18. Not fully recovered from toxicity and/or complications resulting from any intervention prior to initiation of treatment (i.e., ≤1 or baseline, excluding fatigue or hair loss); 19. A history of human immunodeficiency virus (HIV) infection (ie, HIV 1/2 antibody positive) is known.
  • 20. Untreated active hepatitis B; 21. Active HCV-infected subjects (HCV antibody positive and HCV-RNA levels above the lower limit of detection) 22. Vaccination of live vaccine within 30 days before the first dose (1st cycle, 1st day); 23. Pregnant or lactating women 24. Any serious or uncontrolled systemic diseases 25. Any medical history or evidence of disease that may interfere with the outcome of the study, or other conditions that the investigator considers inappropriate for the study.

About this study

Official title: SUNRISE: A Phase II Randomized Control Study of Sintilimab Combined With Anlotinib Versus Standard Platinum-based Chemotherapy as a First-line Treatment in Patients With Advanced NSCLC

This is an open label, multi-center, randomized control phase II trial, to compare the efficacy and safety of sintilimab combined with anlotinib versus standard platinum-based chemotherapy as a first-line treatment in advanced NSCLC patients without driven-gene mutations.

Read the detailed description

This is an open label, multi-center, randomized control study comparing the combination of sintilimab and anlotinib with standard platinum-based chemotherapy in treat-naïve advanced (unresectable stage IIIB, IIIC and IV patients without driven-gene mutations) NSCLC patients. Eligible subjects are 1:1 randomized into the experimental group (sintilimab combined with anlotinib) or the control group (standard platinum-based chemotherapy).

Being tested
sintilimab plus anlotinib, Chemotherapy
Keywords
Advanced, Non-Small Cell Lung Cancer, Sintilimab, PD-1, Anlotinib, Anti-angiogenisis
Medical subject headings
Carcinoma, Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • sintilimab plus anlotinibDrug

    Sintilimab 200 mg administered intravenously (IV) on Day 1 of each 21-day cycle plus anlotinib capsules 12 mg given orally in fasting conditions, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21

  • ChemotherapyDrug

    1. Pemetrexed combined with platinum regimen (non-squamous cell carcinoma): pemetrexed 500mg/m2, intravenous infusion on the first day of each cycle, cisplatin 75mg/m2 or carboplatin AUC 5, intravenous infusion on the first day of each cycle, 1 cycle every 3 weeks (Q3W), 4 cycles in total. Patients who did not progress after 4 cycles received maintenance monotherapy with pemetrexide at the same dose as before.
    2. Gemcitabine combined with platinum regimen (squamous cell carcinoma): gemcitabine 1250mg/m2, intravenous infusion on day 1 and day 8 of each cycle, cisplatin: 75mg/m2 or carboplatin: AUC 5, intravenous infusion on day 1 of each cycle, 1 cycle every 3 weeks (Q3W), 4-6 cycles in total.
Study groups in NCT04124731
Study groupRoleWhat they receive
Sintilimab plus anlotinibExperimentalSintilimab and anlotinib combination therapy
Receives: Drug: sintilimab plus anlotinib
ControlActive comparatorStandard platinum-based chemotherapy
Receives: Drug: Chemotherapy

What is being measured

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

  1. Objective Respond Rate (ORR)

    ORR (per RECIST 1.1 as assessed by the investigator) is defined as the proportion (%) of patients with at least one visit response of complete response (CR) or partial response (PR).

    Measured: up to 24 months after enrollment or study close

Secondary outcomes (4)

  1. Progression Free Survival (PFS)

    PFS (per RECIST 1.1 as assessed by the investigator) is defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression)

    Measured: up to 24 months after enrollment or study close

  2. Disease Control Rate (DCR)

    DCR (per RECIST 1.1 as assessed by the investigator) is defined as the proportion (%) of patients with at least one visit response of complete response (CR) or partial response (PR), or stable disease (SD).

    Measured: up to 24 months after enrollment or study close

  3. Duration of Response (DoR)

    DoR (per RECIST 1.1 as assessed by the investigator) is defined as the time from the date for first documented response of complete response (CR) or partial response (PR) until the date for the first documented response of progressive disease (PD) or death in the absence of progression.

    Measured: up to 24 months after enrollment or study close

  4. Overall Survival (OS)

    OS (per RECIST 1.1 as assessed by the investigator) is defined as the time from the date of randomisation until death due to any cause.

    Measured: up to 24 months after enrollment or study close

Timeline

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

  1. First posted11 Oct 2019
  2. Study startOct 2019 (estimated)
  3. Primary completionApr 2021 (estimated)
  4. Study completionApr 2022 (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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
98 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04124731
Sponsor's protocol ID
SUNRISE
Status last verified
Jul 2019
First submitted
10 Oct 2019
Last updated
11 Oct 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing sintilimab plus anlotinib and Chemotherapy in people with Carcinoma and Non-small Cell Lung Cancer, run by Shanghai 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 13 inclusion and 10 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 11 Oct 2019. 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?

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?

Objective Respond Rate (ORR) (time frame: up to 24 months after enrollment or study close). 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 NCT04124731.

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 11 Oct 2019.

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