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Lung Cancer, Non-Small CellPhase 2NCT06769295

A Phase II Study of AK112 (PD1/VEGF Bispecific) in Combination with Chemotherapy in Patients with NSCLC

A Phase 2 study testing AK112 in people with Lung Cancer, Non-Small Cell, run by Sichuan University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a phase II study. All patients are stage IV non-squamas non-small cell lung cancer(NSCLC) with malignant pleura effusion, Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Lung Cancer, Non-Small Cell
What is being tested?
AK112
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteChina
Study dates
1 Feb 2025to 31 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 of inform consent obtained)；
  • Have histologically- or cytologically-confirmed diagnosis of Stage IV non-squamas NSCLC；
  • The presence of malignant pleural effusion (positive pleural effusion cytology or multiple pleural nodules or thickening with pleural effusion on CT imaging)；
  • Driver gene mutation negative；
  • Have a life expectancy of at least 3 months；
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2；
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  • Has adequate organ function；
  • Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator；
  • Be able to provide formalin fixed, paraffin-embedded (FFPE) tumor tissue obtained from either a core or excisional tumor biopsy；
  • 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；
  • Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures).

Who cannot join

  • Histological or cytological pathology confirmed the presence of small cell carcinoma components, or the main component is squamous cell carcinoma；
  • Active malignancies within the past 3 years, with the exception of tumors in this study and cured local tumors；
  • Is currently participating in a study of an investigational agent or using an investigational device;
  • Active autoimmune disease requiring systemic treatment within 2 years prior to the start of study treatment；
  • Subjects who received any prior treatments targeting VEGFR;
  • Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected);
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  • 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 undergone major surgery within 30 days prior to the first dose of study treatment;
  • 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 received a live virus vaccine within 30 days prior to first dose of study treatment；

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ge Gao, PhD contact

86（028）85421606

gg1023@foxmail.com

China1 site, 1 recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan

    Ge Gao, PhD, 86（028）85421606, gg1023@foxmail.com

    Yongsheng Wang, Prof

    Recruiting

Other trials in China

About this study

Official title: A Phase II Study of AK112 (PD-1/VEGF Bispecific) in Combination with Chemotherapy for Patients with Advanced Non-squamas Non-mall Cell Lung Cancer and Malignant Pleural Effusion

This is a phase II study. All patients are stage IV non-squamas non-small cell lung cancer(NSCLC) with malignant pleura effusion, Eastern Cooperative Oncology Group (ECOG) performance status 0-2. The purpose of this study is to evaluate the efficacy and safety of AK112 in combination with chemotherapy in patients with NSCLC with malignant pleura effusion.

Being tested
AK112
Keywords
NSCLC, AK112, MPE, combination therapy
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.

  • AK112Drug

    Also called Pemetrexed, Carboplatin/Cisplatin

    non-Squamous NSCLC with malignant pleura effusions:Subjects receive AK112 plus Pemetrexed and Carboplatin/Cisplatin on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK112 plus Pemetrexed until progression.

Study groups in NCT06769295
Study groupRoleWhat they receive
non-Squamous NSCLC with MPE:AK112 plus ChemotherapyExperimentalnon-Squamous NSCLC with malignant pleura effusions:Subjects receive AK112 plus Pemetrexed/Taxol and Carboplatin/Cispaltin on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK112 plus Pemetrexed until progression.
Receives: Drug: AK112

What is being measured

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

  1. ORR of MPE

    ORR of malignant pleura effusions is the proportion of subjects with CR or PR , based on WHO Evaluation Criteria .

    Measured: Up to approximately 2 years

Secondary outcomes (7)

  1. PFS of MPE

    PFS of MPE is defined as the time from the date of randomization till the first documentation of effusion progression (per WHO criteria) assessed by the investigator or death due to any cause (whichever occurs first).

    Measured: Up to approximately 2 years

  2. ORR

    ORR is the proportion of subjects with CR or PR , based on RECIST v1.1.

    Measured: Up to approximately 2 years

  3. PFS

    PFS is defined as the time from the date of randomization till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by the investigator or death due to any cause (whichever occurs first).

    Measured: Up to approximately 2 years

  4. OS rate of 1y

    Overall survival rate of 1 year，OS is the time from the date of randomization or first dosing date to death due to any cause.

    Measured: 1 year

  5. DOR

    DOR is the time between the first observed tumor responseto disease progression or relapse based on RECIST Version 1.1

    Measured: Up to approximately 2 years

  6. DCR

    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 approximately 2 years

  7. OS

    OS is the time from the date of randomization or first dosing date to death due to any cause.

    Measured: Up to approximately 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 Jan 2025
  2. Study start1 Feb 2025 (estimated)
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (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
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06769295
Sponsor's protocol ID
HX-AK112-01
Status last verified
Jan 2025
First submitted
3 Jan 2025
Last updated
10 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AK112 in people with Lung Cancer, Non-Small Cell, run by Sichuan 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 11 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 10 Jan 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 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Ge Gao, PhD (86（028）85421606, gg1023@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR of MPE (time frame: Up to approximately 2 years). 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 NCT06769295.

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 Jan 2025.

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