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Small Cell Lung CarcinomaPhase 2NCT04620837

Tislelizumab in Combination With Anlotinib With ES-SCLC as Maintenance Therapy After First Line Chemotherapy

A Phase 2 study testing Tislelizumab and Anlotinib hydrochloride in people with Small Cell Lung Carcinoma, run by Chinese Academy of Medical Sciences 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 The sponsor has not verified this record for over two years, so it may be out of date.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
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Trial summary

To show that maintenance therapy with Tislelizumab plus Anlotinib will prolong Progression Free Survival in subjects with extensive stage disease small cell lung cancer who have completed first line chemotherapy. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Small Cell Lung Carcinoma
What is being tested?
Tislelizumab and Anlotinib hydrochloride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteChina
Study dates
1 Nov 2020to 31 Dec 2023
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

  • Subjects with histologically or cytologically confirmed extensive stage disease SCLC
  • Ongoing response of stable disease or better following 4 cycles of platinum-based first line chemotherapy
  • Patients should enter the study within 5 weeks after the completion of cycle 4 chemotherapy (the last dose).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Extensive-stage disease at diagnosis
  • Patients must have received 4 cycles of platinum-containing chemotherapy and must be at the level of complete remission (CR), partial remission (PR), or disease stabilization (SD) at the time of completion of chemotherapy. According to the The National Comprehensive Cancer Network （NCCN） guidelines, acceptable combination therapy includes cisplatin or carboplatin plus etoposide or irinotecan.
  • The woman patients of childbearing age who must agree to take contraceptive methods (e.g. intrauterine device, contraceptive pill or condom) during the research and within another 6 months after it; who are not in the lactation period and examined as negative in blood serum test or urine pregnancy test within 7 days before the research; The man patients who must agree to take contraceptive methods during the research and within another 6 months after it
  • Otherwise healthy

Who cannot join

  • Subjects with symptomatic Central Nervous System (CNS) metastases
  • Subjects receiving consolidative chest radiation
  • Subjects with active, known, or suspected autoimmune disease are excluded Cancerous meningitis.
  • Pleural effusions that are not controlled by appropriate interventions
  • All side effects attributed to prior anti-cancer therapy must have resolved to Grade 1 or baseline
  • Medical history and concurrent diseases. a) Pregnant or lactating women. b) Active, known or suspected autoimmune diseases. Exclude conditions that require immunosuppressive therapy. d) Previous use of anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibodies (including Ipilimumab or any other T-cell co-stimulation or checkpoint pathway points) The antibody or drug e). The subject has interstitial lung disease, the disease has symptoms, or the disease may affect the discovery or management of suspected drug-related lung toxicity. f) Previous malignancy unless at least prior to participating in the study Completely relieved 2 years ago and requires no additional treatment during the study. g)Based on the investigator's judgment, known medical conditions increase the risk associated with participating in the study or giving the blinded study drug or affecting the interpretation of the findings.
Show all 14Show fewer
  • Physical examination and laboratory tests found. a)Hepatitis B virus （HBV） surface antigen test to determine hepatitis B virus positive, or Hepatitis C virus（ HCV） ribonuclease test to determine hepatitis C virus positive, or HCV antibody test showed acute or chronic infection. b) A history of HIV-positive disease is known or a history of AIDS disease is known. c) Insufficient hematopoietic function. d)Insufficient liver function. e) insufficient pancreatic function
  • Patients get any severe diseases or the ones that cannot be controlled take major surgical treatments, open biopsy, or get overt traumatic injury within 28 days before grouping
  • Patients have any habitus or medical history of hemorrhage, however severe it is; the patients who have non healing wounds, ulcer or fracture after any events with hemorrhage or bleeding (> or =CTCAE level 3)
  • Patients get arterial/venous thrombosis within 6 months, such as cerebrovascular accidents (including temporary ischemic stroke), deep venous thrombosis, and pulmonary embolism
  • Patients ever abuse psychiatric drugs and cannot abstain or who are diagnosed with mental disorder
  • -Patients have participated in other clinical trials of anti-tumor medicine within 4 weeks
  • Patients diagnosed with disease which will severely endanger the security of patients or influence the completion of this research.
  • Allergies and Adverse Drug Reactions: A history of allergies or hypersensitivity reactions to any study drug or other study drug component

Trial locations and contacts

1 site in 1 country.

Yuankai Shi, MD contact

86-10-87788293

syuankaipumc@126.com

China1 site, 1 recruiting

  • National Cancer Center/Cancer Hospitial,Chinese Academy of Medical Sciences and Peking Union Medical College

    Beijing, Beijing Municipality, 100021

    Yuankai Shi, MD, +86-10-87788293, syuankaipumc@126.com

    Recruiting

Other trials in China

About this study

Official title: A Prospective, Open Label, Single-arm, Phase 2 Study of Tislelizumab in Combination With Anlotinib as Maintenance Therapy in Subject With Extensive Stage Small Cell Lung Cancer （ES-SCLC） as Maintenance Therapy After First Line Chemotherapy

To show that maintenance therapy with Tislelizumab plus Anlotinib will prolong Progression Free Survival in subjects with extensive stage disease small cell lung cancer who have completed first line chemotherapy.

Read the detailed description

Most patients with extensive disease small cell lung cancer (ED-SCLC) respond to first line（1L） platinum-based chemotherapy; however, responses are not durable and prognosis is poor. Currently no maintenance treatments are approved in SCLC to prolong the durability of efficacy achieved with 1L chemotherapy. Immuno-oncology agents have demonstrated efficacy in the treatment of ED-SCLC when administered across different lines of therapy. Tislelizumab (Anti-PD-1 antibody) Combine Etoposide+ platinum （EP） had improved median Overall survival （mOS ） to 15.6m of 1L ED-SCLC in the Rationale 206 study. Anlotinib ( RTKi ) had significantly improved PFS \& OS of 3L(third line) ED-SCLC in the ALTER 1202. This phase II study is designed to explore the effect and safety of the combination as maintenance therapy for ED-SCLC after 1L chemotherapy

Being tested
Tislelizumab, Anlotinib hydrochloride
Keywords
Human anti-human PD-1 monoclonal antibody, Receptor Tyrosine Kinase inhibitor(RTKi)
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.

  • TislelizumabDrug

    Tislelizumab：200mg Q3W IV. There will be no dose reduction for Tislelizumab ， if there is no disease progression or serious Treatment Related adverse events(TRAE) , patients will receive Tislelizumab (200mg,Q3W) until progression or death

  • Anlotinib hydrochlorideDrug

    Also called Anlotinib

    Anlotinib hydrochloride capsules: Capsule; specifications 12mg; oral, once a day, every 12mg, continuous medication two weeks after 1 week deactivated. Depending tolerated dose reduction. Medication process: disease control and patients can tolerate the side effects, continued drug use; researchers believe the patient is not fit to continue medication or efficacy evaluation at the end of the clinical progression of medication.

Study groups in NCT04620837
Study groupRoleWhat they receive
Treatment ArmExperimentalTislelizumab：200mg Q3W IV Anlotinib hydrochloride capsules: Capsule; specifications 12mg; oral, once a day, every 12mg, continuous medication two weeks after 1 week deactivated.
Receives: Drug: Tislelizumab; Drug: Anlotinib hydrochloride

What is being measured

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

  1. Rate of progression free survival

    Rate of progression free survival in 6 month

    Measured: 6 months

Secondary outcomes (1)

  1. overall survival

    OS

    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 posted9 Nov 2020
  2. Study start1 Nov 2020
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion31 Dec 2023 (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
NCT04620837
Sponsor's protocol ID
NCC-04254
Status last verified
Oct 2020
First submitted
4 Nov 2020
Last updated
9 Nov 2020
Results posted
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 Tislelizumab and Anlotinib hydrochloride in people with Small Cell Lung Carcinoma, run by Chinese Academy of Medical Sciences 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 7 inclusion and 14 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 9 Nov 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 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 Yuankai Shi, MD (86-10-87788293, syuankaipumc@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of progression free survival (time frame: 6 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 NCT04620837.

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 9 Nov 2020.

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