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NSCLCPhase 1/2NCT04646330

A Trial of AK104 Plus Anlotinib in NSCLC

A Phase 1/2 study testing AK104+anlotinib in people with NSCLC, run by Akeso at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This trial is a single arm, two cohorts, phase Ib/II study. All patients are stage IIIB/C or IV NSCLC, Eastern Cooperative Oncology Group (ECOG) performance status 0-1. Cohort 1 includes treatment naïve patients with advanced NSCLC. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
NSCLC
What is being tested?
AK104+anlotinib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
114 participants
Where
1 siteChina
Study dates
18 Nov 2020to 30 Jul 2025
Phase
Phase 1/2
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

  • 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.
  • 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
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  • 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:Absolute neutrophil count ≥ 1,500/µL;Platelets ≥ 100,000/µL;Hemoglobin ≥ 9 g/dL;Crcl ≥ 50ml/min creatinine clearance may be calculated using the institutional/laboratory standard method.Serum total bilirubin ≤ 1.5 x ULN ;Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN ;Albumin ≥28g/L;International Normalized Ratio (INR) and aPTT <1.5 x ULN. 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

1 site in 1 country.

China1 site

  • Hunan cancer hospital

    Changsha, Hunan

Other trials in China

About this study

Official title: A Phase Ib/II Trial of AK104 Plus Anlotinib in Patients With NSCLC

This trial is a single arm, two cohorts, phase Ib/II study. All patients are stage IIIB/C or IV NSCLC, Eastern Cooperative Oncology Group (ECOG) performance status 0-1. Cohort 1 includes treatment naïve patients with advanced NSCLC. Cohort 2 includes patients with metastatic or recurrent NSCLC after progression on treatment with PD-1/PD-L1. The primary end point are objective response rate per RECIST1.1 and safety. Secondary end points are progression-free survival and overall survival.

Conditions
NSCLC
Being tested
AK104+anlotinib

What participants receive

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

  • AK104+anlotinibDrug

    Subjects receive AK104 10mg/kg intravenously (IV) every 2-week cycle plus anlotinib on Day 1-14 of every 3-week cycle (Q3W) until progression.

  • AK104+anlotinibDrug

    Subjects receive AK104 15mg/kg intravenously (IV) every 3-week cycle plus anlotinib on Day 1-14 of every 3-week cycle (Q3W) until progression.

  • AK104+anlotinibDrug

    Subjects receive AK104 10mg/kg Q3W plus anlotinib 1-14days of every 3-week cycle until progression.

Study groups in NCT04646330
Study groupRoleWhat they receive
AK104 10mg/kg Q2W plus anlotinibExperimentalSubjects receive AK104 10mg/kg every 2-week cycle(Q2W) intravenously (IV) plus anlotinib 1-14days of every 3-week cycle (Q3W) until no more benefits from treatment.
Receives: Drug: AK104+anlotinib
AK104 15mg/kg Q3W plus anlotinibExperimentalSubjects receive AK104 15mg/kg intravenously (IV) plus anlotinib 1-14days of every 3-week cycle (Q3W) until no more benefits from treatment.
Receives: Drug: AK104+anlotinib
AK104 10mg/kg Q3W plus anlotinibExperimentalSubjects receive AK104 10mg/kg Q3W plus anlotinib 1-14days of every 3-week cycle until no more benefits from treatment.
Receives: Drug: AK104+anlotinib

What is being measured

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

  1. Objective Response Rate (ORR)

    objective response rate per RECIST1.1

    Measured: through study completion, an average of 1 year

Secondary outcomes (3)

  1. progession-free survival (PFS)

    progession-free survival per RECIST1.1

    Measured: through study completion, an average of 1 year

  2. overall survival (OS)

    overall survival per RECIST1.1

    Measured: through study completion, an average of 1 year

  3. Disease control rate (DCR)

    The DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks) based on RECIST Version 1.1.

    Measured: Up to 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 posted27 Nov 2020
  2. Study start18 Nov 2020
  3. Primary completion26 Oct 2023
  4. Study completion30 Jul 2025

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
114 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04646330
Sponsor's protocol ID
AK104-208
Status last verified
Aug 2025
First submitted
23 Nov 2020
Last updated
19 Aug 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Chen B, Yao W, Li X, Lin G, Chu Q, Liu H, Du Y, Lin J, Duan H, Wang H, Xiao Z, Sun H, Liu L, Xu L, Xu Y, Xu F, Kong Y, Pu X, Li K, Wang Q, Li J, Li B, Xia Y, Wu L. A phase Ib/II study of cadonilimab (PD-1/CTLA-4 bispecific antibody) plus anlotinib as first-line treatment in patients with advanced non-small cell lung cancer. Br J Cancer. 2024 Feb;130(3):450-456. doi: 10.1038/s41416-023-02519-0. Epub 2023 Dec 18.

    PubMed 38110665

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AK104+anlotinib in people with NSCLC, run by Akeso 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 10 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: finished, as of the sponsor's last update on 19 Aug 2025. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (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 NCT04646330, which also lists 1 linked publication.

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 19 Aug 2025.

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