AzTrials
AzTrials

Small Cell Lung Cancer Extensive StagePhase 2NCT07022301

Sintilimab Plus Anlotinib as Second or Further-line Therapy for ES-SCLC Who Have Progressed After Anti-PD-1/L1 Therapy

A Phase 2 study testing sintilimab combined with anlotinib in people with Small Cell Lung Cancer Extensive Stage and Resistance to Immunotherapy, run by First Affiliated Hospital of Wannan Medical College.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The phase II study enrolled ES-SCLC patients who had disease progression after anti-PD-1/L1 therapy. Participants received intravenous sintilimab 200 mg on day one and oral daily anlotinib 8-12 mg on days 1-14 once every three weeks per cycle. The primary endpoint was objective response rate (ORR). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
sintilimab combined with anlotinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
No sites listed yet
Study dates
Jul 2025to May 2029
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

  • 1. At the time of signing the informed consent form, both men and women must be at least 18 years old.
  • 2. Widespread recurrent small cell lung cancer diagnosed by histology or cytology and progressing after 3 months of standard immunization.
  • 3. According to RECIST 1.1 criteria, patients must have at least one measurable lesion (lesions that have undergone radiotherapy must show clear progression in order to be considered measurable lesions).
  • 4. ECOG PS score: 0-1 points.
  • 5. Expected survival period ≥ 3 months.
  • 6. Important organ functions must meet the following standards:
Show all 21Show fewer
  • 1) Blood routine examination: (No blood transfusion or use of cytokine drugs such as G-CSF for corrective treatment within 2 weeks before screening)
  • Hemoglobin (HB) ≥ 90 g/L;
  • Absolute neutrophil count (ANC) ≥ 1.5 × 10*9/L;
  • Platelet count (PLT) ≥ 90 × 10*9/L;
  • White blood cell count (WBC) ≥ 3.0 × 109/L and<15 × 10*9/L; 2) Other tests: (did not receive human serum albumin injection within 14 days before screening)
  • AST and ALT ≤ 3 x ULN;
  • ALP ≤ 2.5 x ULN (≤ 5 x ULN if there is bone metastasis);
  • TBiL≤1x ULN；
  • ALB≥30g/L；
  • Cr ≤ 1.5 x ULN, while creatinine clearance rate (CrCL) ≥ 60mL/min (Cockcroft Gault formula);
  • TSH ≤ 1 x ULN (if abnormal, FT3 and FT4 levels should be examined simultaneously. If FT3 and FT4 levels are normal, they can be included in the group)
  • APTT ≤ 1.5 x ULN, while INR or PT ≤ 1.5 x ULN (not receiving anticoagulant therapy).
  • Male QTc<450 ms, female QTc<470 ms, LVEF ≥ 50%
  • 7. Non surgical sterilization or female patients of childbearing age must undergo a serum pregnancy test within 3 days before the first medication, and the result must be negative; And it must be non lactating. Female patients of childbearing age or male patients with partners of childbearing age must agree to use efficient contraception methods during the study period and within 6 months after the last administration of the study drug.
  • 8. The patient voluntarily joined this clinical study and signed an informed consent form, with good compliance and the ability to cooperate with follow-up.

Who cannot join

  • 1. Imaging shows that the tumor has invaded large blood vessels or has unclear boundaries with blood vessels.
  • 2. Imaging shows the presence of obvious pulmonary hollow or necrotic tumors.
  • 3. Symptomatic central nervous system metastases (such as brain metastases or meningeal metastases).
  • 4. Patients with conditions such as malignant meningitis and spinal cord compression.
  • 5. Persons who have suffered from other malignant tumors in the past or at the same time, unless they are skin basal cell carcinoma, superficial bladder cancer, skin squamous cell carcinoma, cervical carcinoma in situ or other carcinoma in situ that have achieved complete remission at least 5 years before screening and do not need or are not expected to need other treatment during the study period.
  • 6. Those who have had or currently have objective evidence of idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, tissue pneumonitis (such as bronchitis, occlusive vasculitis), drug-induced pneumonia, or screening period CT showing active pneumonia or lung function examination confirming severe impairment of lung function.
Show all 22Show fewer
  • 7. Individuals with any active, known or suspected autoimmune diseases (including but not limited to: myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, enteritis, multiple sclerosis, vasculitis, glomerulonephritis, uveitis, pituitary inflammation, hyperthyroidism, etc.). Type I diabetes patients who are allowed to receive stabilizing dose insulin treatment, hypothyroidism patients who only need hormone replacement treatment, and skin diseases (such as eczema, vitiligo, or psoriasis) that do not require systemic treatment and have no acute deterioration within 1 year before the screening period.
  • 8. Patients suspected of having active pulmonary tuberculosis should undergo chest X-ray, sputum examination, and exclusion based on clinical symptoms and signs. Individuals with a history of active pulmonary tuberculosis infection within the previous year should be excluded, even if they have been treated; Subjects with a history of active pulmonary tuberculosis infection more than one year ago should also be excluded unless it is proven that the previous course and type of anti tuberculosis treatment used were appropriate.
  • 9. Clinical symptoms or diseases of the heart that have not been well controlled, such as: (1) NYHA grade 2 or above heart failure, (2) unstable angina, (3) myocardial infarction within 1 year, and (4) clinically significant supraventricular or ventricular arrhythmias that require treatment or intervention.
  • 10. Patients with hypertension who cannot achieve good control with antihypertensive medication (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg).
  • 11. Urine routine showed urinary protein ≥++, and 24-hour urinary protein quantification was confirmed to be>1.0 g through quantitative detection of urinary protein.
  • 12. For individuals with a tendency towards thrombosis or undergoing thrombolytic/anticoagulant therapy, prophylactic use of low-dose aspirin (≤ 100mg/d) and low molecular weight heparin (≤ 40mg/d) is allowed.
  • 13. Those who have received>30 Gy of chest radiation therapy within the first 6 months of randomization, and have undergone major surgical treatment within the first 4 weeks of randomization, but have not recovered from the toxicity and/or complications of previous intervention measures to NCI-CTC AE ≤ 1 degree (except for hair loss and indicators clearly defined in the inclusion criteria).
  • 14. Within the first 6 months of randomization, there have been arterial/venous thrombotic events, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism.
  • 15. Individuals with a daily cough/hemoptysis volume greater than 2.5mL within the first month of randomization. Individuals with a history of hereditary or acquired bleeding or coagulation dysfunction. Within the first 3 months of randomization, there have been significant clinical bleeding symptoms or clear bleeding tendencies, such as gastrointestinal bleeding, hemorrhagic gastric ulcers, etc.
  • 16. Participants who have experienced severe infections within the previous month prior to randomization, including but not limited to infection complications requiring hospitalization, bacteremia, severe pneumonia, etc; Subjects with any active infection, or experiencing unexplained fever>38.5 ℃ during screening or before the first dose.
  • 17. Patients who have received anti-tumor vaccines or other immunomodulatory drugs (such as interleukin-2, thymosin, shiitake polysaccharides, etc.) within the previous month of randomization, or patients who will receive attenuated live vaccines.
  • 18. Subjects who have received systemic therapy with corticosteroids (>10 mg/day of prednisone or other equivalent hormones) or other immunosuppressive agents within the previous month prior to randomization. In the absence of active autoimmune diseases, inhalation or topical use of corticosteroids, as well as adrenal hormone replacement therapy with a dose ≤ 10 mg/day of prednisone efficacy dose, are allowed.
  • 19. Known to have a positive history of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS). It is known that there is active hepatitis or co infection with hepatitis B and hepatitis C. (hepatitis B reference: HBsAg is positive, and the HBV DNA detection value exceeds the upper limit of normal value; Hepatitis C reference: HCV antibody positive and HCV virus titer detection value exceeding the upper limit of normal.
  • 20. are known to have experienced allergic reactions to other monoclonal antibodies or any component of anlotinib.
  • 21. Those who are currently participating in other clinical studies or have been randomized for less than 4 weeks (or 5 half lives of the study drug) since the end of the previous clinical study (last dose);
  • 22. According to the researchers' assessment, there are other factors that may affect the research results or lead to the forced termination of this study, such as alcohol abuse, drug use, drug abuse, other serious illnesses (including mental illnesses) that require concurrent treatment, serious laboratory test abnormalities, and family or social factors that may affect medication safety.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Yiping Zhu contact

0553-5738279

zhuyiping@wnmc.edu.cn

About this study

Official title: A Phase II Study Evaluating the Safety and Efficacy of Sintilimab Plus Anlotinib as Second or Further-line Therapy for ES-SCLC Who Have Progressed After Anti- PD- 1/L1 Therapy

The phase II study enrolled ES-SCLC patients who had disease progression after anti-PD-1/L1 therapy. Participants received intravenous sintilimab 200 mg on day one and oral daily anlotinib 8-12 mg on days 1-14 once every three weeks per cycle. The primary endpoint was objective response rate (ORR). The secondary endpoints included overall survival (OS), progression-free survival (PFS) , disease control rate (DCR) and safety.

Being tested
sintilimab combined with anlotinib

What participants receive

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

  • sintilimab combined with anlotinibDrug

    Patients who met the inclusion criteria were treated with Sintilimab plus anlotinib every 3 weeks until disease progression or intolerable adverse reactions or death(up to 24 months).

Study groups in NCT07022301
Study groupRoleWhat they receive
Experimental armExperimentalDrug: Sintilimab combined with anlotinib
Receives: Drug: sintilimab combined with anlotinib

What is being measured

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

  1. ORR

    the rate of patients with PR and CR

    Measured: 24 months

Secondary outcomes (3)

  1. OS

    The time from the beginning of treatment to the time when the patient dies from any cause

    Measured: 24 months

  2. PFS

    The time from the beginning of treatment to the time when the disease progresses or the patient dies from any cause

    Measured: 24 months

  3. AE

    Safety will be evaluated by AE

    Measured: 24 months

Timeline

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

  1. First posted15 Jun 2025
  2. Study startJul 2025 (estimated)
  3. Primary completionMay 2027 (estimated)
  4. Study completionMay 2029 (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
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07022301
Sponsor's protocol ID
2025-ethics-48
Status last verified
Jun 2025
First submitted
22 May 2025
Last updated
15 Jun 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing sintilimab combined with anlotinib in people with Small Cell Lung Cancer Extensive Stage and Resistance to Immunotherapy, run by First Affiliated Hospital of Wannan Medical College.

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 21 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: opening soon, as of the sponsor's last update on 15 Jun 2025. 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?

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 Yiping Zhu (0553-5738279, zhuyiping@wnmc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: 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 NCT07022301.

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 15 Jun 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in