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Non-small Cell Lung CancerPhase 2NCT04544644

A Study of Combination Therapy in NSCLC

A Phase 2 study testing AK104+anlotinib in people with Non-small Cell Lung Cancer, run by Chinese PLA General 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 The sponsor has not verified this record for over two years, so it may be out of date.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 trial is a single arm, two cohorts, phase II study. All patients are stage IIIB-IV NSCLC, Eastern Cooperative Oncology Group (ECOG) performance status 0-1 and no sensitizing mutation of the epidermal growth factor receptor gene or translocation of the anaplastic lymphoma kinase gene. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
AK104+anlotinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
Sep 2020to Sep 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

  • Aged 18 to 75 years old (at the time consent is obtained);
  • Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures);
  • Have histologically- or cytologically-confirmed diagnosis of StageIIIB/C or IV NSCLC;
  • Additional Inclusion Criteria for Cohort 1: Has metastatic or recurrent NSCLC after progression on treatment with platinum-based chemotherapy and PD-1/PD-L1, given concurrently or sequentially;
  • Additional Exclusion Criteria for Cohort 2: Have no prior systemic chemotherapy for metastatic disease: at least 6 months since prior adjuvant chemotherapy;
  • EGFR/ALK negative;
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  • Be able to provide formalin fixed, paraffin-embedded (FFPE) tumor tissue obtained from either a core or excisional tumor biopsy;
  • Have a life expectancy of at least 3 months;
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
  • Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as determined by the site study team;
  • Has adequate organ function as defined by: (1) Absolute neutrophil count >= 1,500/uL; (2) Platelets >= 100,000/uL; (3) Hemoglobin >= 9 g/dL; (4) Crcl >= 50ml/min; creatinine clearance may be calculated using the institutional/laboratory standard method; (5) Serum total bilirubin <= 1.5 ULN; (6) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 2.5 ULN; (7) Albumin >= 28g/L; (8) International Normalized Ratio (INR) and aPTT <1.5 ULN; (9) Left ventricular ejection fraction >= 50%;
  • Have recovered from the effects of any prior radiotherapy or surgery;
  • All female and male subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 120 days after the last dose of study treatment.

Who cannot join

  • Is currently participating in a study of an investigational agent or using an investigational device;
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy within 2 years prior to the first dose of study treatment;
  • Has undergone major surgery within 30 days of Study Day 1;
  • Has a known additional malignancy that is progressing or requires systemic treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
  • Has known active central nervous system (CNS) metastases;
  • Has carcinomatous meningitis;
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  • Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment NOTE: Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study;
  • Has an active infection requiring systemic therapy;
  • Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected);
  • History of myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or surgery within 12 months prior to day 1 of study treatment;
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of this subject to participate, in the opinion of the treating investigator;
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study;
  • Has received a live virus vaccine within 30 days of the planned first dose of study therapy;
  • Is pregnant, breastfeeding, or expecting to conceive or father a child within the projected duration of the study including 120 days following the last dose of study treatment;
  • Has any concurrent medical condition that, in the opinion of the Investigator, would complicate or compromise compliance with the study or the well-being of the subject.

Trial locations and contacts

No sites are listed yet.

weiwei Shi contact

+86 01066875308

shiweiwei301@sina.com

About this study

Official title: A Phase II Study of AK104 (Binding Kenetics to PD-1 and CTLA-4) in Combination With Anlotinib in Patients With Advanced NSCLC

This trial is a single arm, two cohorts, phase II study. All patients are stage IIIB-IV NSCLC, Eastern Cooperative Oncology Group (ECOG) performance status 0-1 and no sensitizing mutation of the epidermal growth factor receptor gene or translocation of the anaplastic lymphoma kinase gene. Cohort 1 includes patients with metastatic or recurrent NSCLC after progression on treatment with platinum-based chemotherapy and PD-1/PD-L1, given concurrently or sequentially. Cohort 2 includes treatment naïve patients with advanced NSCLC. All patients will recieve AK104 15mg/kg every 3 weeks(for up to 2 years) and anlotinib(12mg/d). The primary end point are objective response rate per RECIST1.1 and safety. Secondary end points are progression-free survival and overall survival.

Being tested
AK104+anlotinib
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • AK104+anlotinibDrug

    AK 104 is given by intravenous infusion and anlotinib is given by oral.

Study groups in NCT04544644
Study groupRoleWhat they receive
treatment armExperimentalAK104+anlotinib
Receives: Drug: AK104+anlotinib

What is being measured

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

  1. ORR

    objective response rate per RECIST1.1

    Measured: through study completion, an average of 1 year

Secondary outcomes (1)

  1. PFS and OS

    progression-free survival and overall survival

    Measured: through study completion, an average of 2 years

Timeline

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

  1. First posted10 Sep 2020
  2. Study startSep 2020 (estimated)
  3. Primary completionSep 2022 (estimated)
  4. Study completionSep 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
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04544644
Sponsor's protocol ID
IIT-001
Status last verified
Sep 2020
First submitted
29 Aug 2020
Last updated
10 Sep 2020
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 AK104+anlotinib in people with Non-small Cell Lung Cancer, run by Chinese PLA General 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 15 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 10 Sep 2020. 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?

Contact weiwei Shi (+86 01066875308, shiweiwei301@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: through study completion, an average of 1 year). 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 NCT04544644.

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 10 Sep 2020.

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