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CarcinomaPhase 2NCT03765775

Anlotinib Plus Sintilimab for NSCLC Patients With First-generation EGFR-TKIs Drug Resistance Along With T790M Negative

A Phase 2 study testing Sintilimab and Anlotinib Hydrochloride in people with Carcinoma and Non-small Cell Lung Cancer, run by First Hospital of Shijiazhuang City 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is an efficacy and safety study of Anlotinib combined with Sintilimab (IBI 308) in participants with advanced or metastatic non-small cell lung cancer (NSCLC) who have received first-generation EGFR-TKIs resistance along with T790M negative. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Sintilimab and Anlotinib Hydrochloride
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
20 Nov 2018to 31 Dec 2021
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

  • The subjects volunteered to participate in this study and signed the informed consent form, with good compliance and follow-up.
  • Male or female patients aged 18-75 years old.
  • Has a histologically-confirmed or cytologically confirmed diagnosis of stage IV nonsquamous NSCLC.
  • Has confirmation that epidermal growth factor receptor (EGFR) mutation，with first-generation EGFR-TKIs drug resistance T790M negative .
  • Has measurable disease.
  • There is at least one target lesion that has not received radiotherapy in the past 3 months, and it can be accurately measured in at least one direction (the maximum diameter needs to be recorded) by magnetic resonance imaging (MRI) or computed tomography (CT), in which conventional CT is greater than 20mm or spiral CT is greater than 10mm.
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  • Has a life expectancy of at least 3 months.
  • Has a performance status of 0 or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
  • Has adequate organ function.
  • Patients with asymptomatic or mild brain metastasis may be enrolled.
  • If female of childbearing potential, is willing to use adequate contraception for the course of the study through 120 days after the last dose of study medication or through 180 days after last dose of chemotherapeutic agents.
  • If male with a female partner(s) of child-bearing potential, must agree to use adequate contraception starting with the first dose of study medication through 120 days after the last dose of study medication or through 180 days after last dose of chemotherapeutic agents.

Who cannot join

  • 1. Squamous cell carcinoma (including adenosquamous carcinoma);Small cell lung cancer (including small cell cancer and non-small cell mixed lung cancer).
  • 2.ALK(Anaplastic Lymphoma kinase) positive. 3.Imaging (CT or MRI) showed that the tumor lesion invaded the central tumor of local large blood vessels;Or there is obvious pulmonary cavitation or necrotic tumor.
  • 4.History and complications
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.(patients with brain metastasis who have completed treatment 14 days before enrollment and have stable symptoms can be included in the group, but they need to be confirmed as having no symptoms of cerebral hemorrhage by brain MRI, CT).
  • Have Participated in other clinical studies or less than 4 weeks before the end of treatment in the previous clinical study.
  • Other active malignancies requiring concurrent treatment.
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  • Known history of prior malignancy except if participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy, except for successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ cancers.
  • Patients who have not recovered to level 1 or lower of NCI-CTCAE4.0 （The Common Terminology Criteria for Adverse Events 4.0）after previous systemic anti-tumor treatment with anti-tumor treatment-related adverse reactions (except hair loss).
  • Abnormal coagulation function (INR(international normalized ratio) >1.5 or PT(prothrombin time) > ULN+4 s or APTT(activated partial thromboplastin time ) > 1.5ULN), with bleeding tendency or receiving thrombolytic or anticoagulant treatment.
  • Is expected to require any other form of antineoplastic therapy while on study.
  • Received a live-virus vaccination within 30 days of planned start of study medication.
  • Known sensitivity to any component of Anlotinib or Sintilimab.
  • Has active autoimmune disease that has required systemic treatment in past 2 years.
  • Is on chronic systemic steroids.
  • Has an active infection requiring therapy.
  • Has known history of Human Immunodeficiency Virus (HIV).
  • Has known active Hepatitis B or C.
  • Has known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial.
  • Is a regular user (including "recreational use") of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol).
  • Has symptomatic ascites or pleural effusion.
  • Has interstitial lung disease or a history of pneumonitis that required oral of IV glucocorticoids to assist with management.
  • Two or more combination therapies for hypertension that are still uncontrollable (systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg).
  • Arteriovenous thrombosis events occurred within 12 months before enrollment, such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism.
  • clinically significant hemoptysis occurred within 3 months before enrollment (hemoptysis > 50ml daily);Or bleeding symptoms of significant clinical significance or with a clear bleeding tendency, such as gastrointestinal bleeding, bleeding gastric ulcer, baseline stool occult blood ++ or above, or suffering from vasculitis.
  • factors that significantly affect oral drug absorption, such as inability to swallow, chronic diarrhea and intestinal obstruction.
  • Is pregnant or breastfeeding, or expecting to conceive or father children prior to 120 days after the last dose of study medication or through 180 days after last dose of chemotherapeutic agents.

Trial locations and contacts

1 site in 1 country.

Yan Zhang, M.D. contact

17603119607 ext. +86

13315978836@163.com

China1 site, 1 recruiting

  • The First Hospital of Shijiazhuang

    Shijiazhuang, Hebei, 050011

    Yan Zhang, 17603119607 ext. +86, 13315978836@163.com

    Yanan Duan, 15931106929 ext. +86, yanan2006@sohu.com

    Recruiting

Other trials in China

About this study

Official title: A Randomized, Phase II Study of Anlotinib Combined With Sintilimab(IBI 308) in First-generation EGFR-TKIs Drug Resistance Along With T790M Negative NSCLC

This is an efficacy and safety study of Anlotinib combined with Sintilimab (IBI 308) in participants with advanced or metastatic non-small cell lung cancer (NSCLC) who have received first-generation EGFR-TKIs resistance along with T790M negative.

Read the detailed description

Participants receive Sintilimab(IBI 308) 200 mg, administered as intravenous (IV) infusion on Day 1, Anlotinib 12mg, administered as PO on Day1-14 of each 21-day cycle until documented PD.The primary hypothesis of this study is that participants will have a longer Progression Free Survival (PFS), as assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) when treated with Anlotinib plus Sintilimab(IBI 308).

Being tested
Sintilimab, Anlotinib Hydrochloride
Keywords
Non-small Cell Lung Cancer, Anlotinib, Sintilimab
Medical subject headings
Carcinoma, Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

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

  • SintilimabBiological

    Participants receive Sintilimab(IBI 308) 200 mg, administered as intravenous (IV) infusion on Day 1 of each 21-day cycle

  • Anlotinib HydrochlorideDrug

    Also called Anlotinib

    Participants receive Anlotinib 10 mg, administered as PO on Day 1-14 of each 21-day cycle

Study groups in NCT03765775
Study groupRoleWhat they receive
Anlotinib Hydrochloride+SintilimabExperimentalParticipants receive Sintilimab (IBI 308) 200 mg, administered as intravenous (IV) infusion on Day 1 of each 21-day cycle , Anlotinib 12mg, administered as PO on Day1-14 of each 21-day cycle until documented PD
Receives: Biological: Sintilimab; Drug: Anlotinib Hydrochloride

What is being measured

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

  1. Progression-Free Survival (PFS)

    PFS was defined as the time from randomization to documented disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or death due to any cause, whichever occurred first and was based on blinded independent central radiologists' (BICR) review. Progressive Disease (PD) was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. (Note: the appearance of one or more new lesions was also considered progression). Participants were evaluated every 9 weeks with radiographic imaging to assess their response to treatment.

    Measured: 6 months

Secondary outcomes (2)

  1. Over Survival(OS)

    OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. In those instances where participants were confirmed to be alive on the visit cut-off date of 09 May 2016, survival was censored as of 09 May 2016.

    Measured: 2years

  2. Objective Response Rate (ORR)

    ORR was defined as the percentage of participants in the analysis population who experienced a Complete Response (CR; disappearance of all target lesions) or a Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions) and was assessed using RECIST 1.1 based on BICR evaluation.

    Measured: 2yeas

Timeline

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

  1. First posted5 Dec 2018
  2. Study start20 Nov 2018
  3. Primary completion31 Dec 2019 (estimated)
  4. Study completion31 Dec 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
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
NCT03765775
Sponsor's protocol ID
LC01
Status last verified
Dec 2018
First submitted
4 Dec 2018
Last updated
6 Dec 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sintilimab and Anlotinib Hydrochloride in people with Carcinoma and Non-small Cell Lung Cancer, run by First Hospital of Shijiazhuang City 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 12 inclusion and 26 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 Dec 2018. 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 Yan Zhang, M.D. (17603119607 ext. +86, 13315978836@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (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 NCT03765775.

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 Dec 2018.

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