AzTrials
AzTrials

Small Cell Lung CancerPhase 2/3NCT04192682

Anlotinib Combined With Sintilimab as Second-line Treatment or Beyond in Patients With Small Cell Lung Cancer

A Phase 2/3 study testing Anlotinib Hydrochloride in people with Small Cell Lung Cancer, run by Changzhou Cancer Hospital of Soochow University at 1 site in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Trial summary

Immunotherapy combined with anti-angiogenic therapy can achieve better results in patients with second-line and above small cell lung cancer Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small Cell Lung Cancer
What is being tested?
Anlotinib Hydrochloride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
8 May 2019to 1 Jul 2021
Phase
Phase 2/3
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

  • Patients should participate in the study voluntarily and sign informed consent;
  • Male or female aged over 18 years;
  • Histological documentation of small cell lung cancer
  • Advanced small cell lung cancer who failed first-line chemotherapy ,at least one measurable lesion (by RECIST1.1)
  • ECOG PS:0-2,.
  • Life expectancy of more than 3 months
Show all 13Show fewer
  • The laboratory results at the screening point must meet the following requirements:
  • Blood routine: the absolute neutrophile count (ANC) shoud be more than 1.0 x 109/L, the platelet count (PLT) should be more than 100 x 109/L, the hemoglobin (HGB) should be more than 90g/L (no blood transfusion or erythropoietin dependence within 7 days);
  • Liver function: total bilirubin (TBIL) should be less than or equal to 1.5 times of the upper limit of normal (ULN); avoid the subjects with liver metastasis, who had the levels of ALT and AST less than the 2.5 times of ULN; and the levels of ALT and AST in subjects with liver metastasis should less than the 5 times of ULN;
  • Renal function: the level of serum creatinine (Cr) should less than 1.5 times of ULN or the clearance ratio of Cr should higher than 60 mL/min
  • (Cockcroft-Gault formula) and the test results of urine routine showed the urine protein (UPRO) content should less than 2 + or should less than 1 g at the 24-hour urinary protein quantification;
  • For female subjects with reproductive age, the urine or serum pregnancy test should be negative within three days before receiving the first administration of the researched drug (the first cycle, first day). If the urine pregnatncy test is not enough to confirm the negative results, then the blood pregnancy test is required.
  • The compliance of the research programs is expected to be good.

Who cannot join

  • Patients who have been used anlotinib or Sintilimab;
  • Other malignant tumors (except clinically cured cervical carcinoma in situ, basal cell or squamous cell skin cancer and papillary thyroid cancer) that were concurrently diagnosed or have occurred within 5 years.
  • The patients who had received chemotherapy, radiotherapy or other experimental anticancer therapy within 4 weeks before treatment; those who had received local radiotherapy in the past could be included in this research, if the following conditions were meet: radiotherapy was performed more than 4 weeks before the beginning of this study (brain radiotherapy was performed more than 2 weeks), and the target lesions selected in this study were not in the radiotherapy area, or the target lesions were in the radiotherapy area, but the progress was confirmed.
  • Systematic systemic treatment with Chinese herbal medicine or immunomodulatory drugs (including thymosin, interferon and interleukin, except for local use of pleural effusion) was given within 2 weeks before the first administration.
  • Received live attenuated vaccine within 4 weeks before the first administration (or planned to receive live vaccine during the study period);
  • Note: Inactivated (killed) virus vaccines for seasonal influenza are allowed within 4 weeks before the first administration, but live attenuated influenza vaccines are not allowed.
Show all 25Show fewer
  • Patients had undergone large and medium-sized operations or unhealed surgical incisions, ulcers or fractures within 4 weeks before the first administration.
  • Patients who were undergoing any other forms of immunosuppressive therapy, not including local glucocorticoids or physiological dose of systemic glucocorticoids (<10 mg/day prednisone or equivalent doses of glucocorticoids) through nasal spray, inhalation or other routes, within 7 days before the first administration.
  • Patients had a history of non-infectious pneumonia requiring glucocorticoid therapy or currently have interstitial lung disease one year before the first administration.
  • Active autoimmune diseases requiring systemic treatment (e.g. using the disease-relieving drugs, corticosteroids or immunosuppressants) occurred within two years before the first administration. Allow the use of alternative therapies (such as thyroxine, insulin or physiological corticosteroids for adrenal or pituitary insufficiencies).
  • Patients with Asymptomatic central nervous metastasis; For patients who had stable symptoms (> 2 weeks) after treatment of brain metastases, they can participate in this study as long as they meet all the following criteria: there are measurable lesions outside the central nervous system; no metastases of the midbrain, pons, cerebellum, medulla oblongata or spinal cord; no history of intracranial hemorrhage in the past; stop the discontinuation of hormone therapy 7 days before the medication treatment;
  • Before the start of treatment, patients who had not been fully recovered from the toxicity and/or complications caused by any intervention (i.e., less than grade 1 or reaching the baseline, excluding fatigue or alopecia);
  • Patients who had the uncontrollable third interstitial effusion (e.g. pleural effusion/pericardial effusion).
  • Patients who had any unstable systemic disease: including but not limited to active infections, unstable angina pectoris, cerebrovascular accident or transient ischemic attack (within 6 months before screening), myocardial infarction (within 6 months before screening), congestive heart failure [New York Heart Association (NYHA) Classification >Class II], severe arrhythmias requiring medication treatment, liver, kidney or metabolic disease;
  • Patients who had received solid organ or blood system transplantation, except corneal transplantation.
  • A known history of human immunodeficiency virus (HIV) infection (i.e. positive HIV 1/2 antibody);
  • Active or current tuberculosis requiring medical intervention, including but not limited to tuberculosis;
  • Patients who had untreated active hepatitis B; Note: Hepatitis B patients could be included in this research if they meet the following criteria:
  • The hepatitis B virus (HBV) load must be less than 1000 copies/ml (200 IU/ml) before the first administration. Anti-HBV therapy should be taken throughout the study period to avoid viral reactivation. For subjects who had HBcAb (+), HBsAg (-), HBsAb (-), HBsAb (-) and HBV viral load (-), no prophylactic anti-HBV treatment is required, but virus reactivation needs to be closely monitored.
  • Subjects with active hepatitis c virus (HCV) infection (HCV antibody positive and HCV-RNA level higher than the detection limit);
  • Subjects who had severe allergic reactions (> grade 3) to the active ingredients and any excipients of Sindelimab, Anlotinib hydrochloride.
  • Pregnant or lactating women or women preparing for pregnancy or lactation during the study period;
  • For men or women at risk of conception, and they disagree with the application of effective contraception during the study period and within 90 days after the last administration.
  • Patients who had a history of alcoholism or drug abuse;
  • Other conditions that researchers considered not suitable for including in this research.

Trial locations and contacts

1 site in 1 country.

Tong Zhou contact

+86-519-69807727

zhoutong2930@163.com

China1 site, 1 recruiting

  • Changzhou Cancer Hospital of Soochow University

    Changzhou, Jiangsu, 213000

    Tong Zhou, 15861153525, zhoutong2930@163.com

    Recruiting

Other trials in China

About this study

Immunotherapy combined with anti-angiogenic therapy can achieve better results in patients with second-line and above small cell lung cancer

Read the detailed description

Through this study, it was found that Anlotinib combined with Sintilimab has a better survival benefit. At the same time, genetic analysis and immunohistochemical methods have been used to predict the predictive value of targeted therapy combined with Sintilimab.

Being tested
Anlotinib Hydrochloride
Keywords
Small Cell Lung Cancer, Anlotinib, Sintilimab, Third-line Treatment or Beyond
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.

  • Anlotinib HydrochlorideDrug

    Also called Sintilimab

    Anlotinib Day 1 to day 14 followed by 7 days off treatment in a 21-day cycle, Combined With Sintilimab 200mg/time，21-day cycle。

Study groups in NCT04192682
Study groupRoleWhat they receive
Anlotinib Combined With SintilimabExperimentalAnlotinib Day 1 to day 14 followed by 7 days off treatment in a 21-day cycle, Combined With Sintilimab 200mg/time，21-day cycle。
Receives: Drug: Anlotinib Hydrochloride

What is being measured

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

  1. Progress free survival

    PFS is defined as the length of time from random assignment to disease progression or to death resulting from any cause other than the progress.

    Measured: At least 1 year following the conclusion of immunotherapy

Secondary outcomes (2)

  1. Overall Survival

    Overall Survival is defined as the length of time from random assignment to death or to last contact.

    Measured: At least 1 year following the conclusion of immunotherapy

  2. Objective Response Rate

    Objective response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response according to Response Evaluation Criteria in Solid Tumors 1.1（RECIST1.1）

    Measured: At least 1 year following the conclusion of immunotherapy

Timeline

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

  1. First posted10 Dec 2019
  2. Study start8 May 2019
  3. Primary completion1 Mar 2021 (estimated)
  4. Study completion1 Jul 2021 (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 2/3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04192682
Sponsor's protocol ID
CHSU2019011
Status last verified
Jan 2020
First submitted
22 Apr 2019
Last updated
6 Jan 2020
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 2/3 study testing Anlotinib Hydrochloride in people with Small Cell Lung Cancer, run by Changzhou Cancer Hospital of Soochow 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 13 inclusion and 25 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 6 Jan 2020. 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Tong Zhou (+86-519-69807727, zhoutong2930@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progress free survival (time frame: At least 1 year following the conclusion of immunotherapy). 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 NCT04192682.

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 6 Jan 2020.

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