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NSCLCPhase 2NCT04736823

A Trial of AK112 (PD1/VEGF Bispecific) in Combination With Chemotherapy in Patients With NSCLC

A Phase 2 study testing AK112, Pemetrexed and Paclitaxel in people with NSCLC, run by Akeso at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a phase II study. All patients are stage IIIB/C or IV non-small cell lung cancer(NSCLC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1. The purpose of this study is to evaluate the efficacy and safety of AK112 in combination with chemotherapy in patients with 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?
AK112, Pemetrexed and Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
265 participants
Where
1 siteChina
Study dates
1 Feb 2021to Dec 2026
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).
  • 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 Stage IIIB/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 assessed by investigator
  • Has adequate organ function
  • 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 prior to the first dose of study treatment;
  • Has a known history of prior malignancy except that 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 prior to first dose of study treatment
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-Sen University Cancer Center

    Guanzhou, Guangdong

Other trials in China

About this study

Official title: A Phase II Trial of AK112 (PD1/VEGF Bispecific) in Combination With Chemotherapy in Patients With NSCLC

This is a phase II study. All patients are stage IIIB/C or IV non-small cell lung cancer(NSCLC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1. The purpose of this study is to evaluate the efficacy and safety of AK112 in combination with chemotherapy in patients with NSCLC.

Conditions
NSCLC

What participants receive

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

Study groups in NCT04736823
Study groupRoleWhat they receive
Part1 Cohort1(AK112 + Pemetrexed or Paclitaxel+Carboplatin)Experimentalnon-Squamous NSCLC:Subjects receive AK112 plus Pemetrexed and Carboplatin on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK112 plus Pemetrexed until progression. Squamous NSCLC:Subjects receive AK112 plus Paclitaxel and Carboplatin on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK112 until progression.
Receives: Drug: AK112; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Carboplatin
Part1 Cohort2(AK112 + Pemetrexed +Carboplatin)ExperimentalSubjects receive AK112 plus Pemetrexed and Carboplatin on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK112 plus Pemetrexed until progression.
Receives: Drug: AK112; Drug: Pemetrexed; Drug: Carboplatin
Part1 Cohort3(AK112 + Docetaxel)ExperimentalSubjects receive AK112 plus Docetaxel on Day 1 of every 3-week cycle (Q3W) until progression.
Receives: Drug: AK112; Drug: Docetaxel
Part2 (AK112 + Pemetrexed or Paclitaxel+Carboplatin)Experimentalnon-Squamous NSCLC:Subjects receive AK112 plus Pemetrexed and Carboplatin on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK112 plus Pemetrexed until progression. Squamous NSCLC:Subjects receive AK112 plus Paclitaxel and Carboplatin on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK112 until progression.
Receives: Drug: AK112; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Carboplatin
Part3 group A(AK112 + Docetaxel)ExperimentalSubjects receive AK112 plus Docetaxel on Day 1 of every 3-week cycle (Q3W) until progression.
Receives: Drug: AK112; Drug: Docetaxel
Part3 group B(AK112)ExperimentalSubjects receive AK112 on Day 1 of every 3-week cycle (Q3W) until progression.
Receives: Drug: AK112
Part3 group C(Docetaxel)ExperimentalSubjects receive Docetaxel on Day 1 of every 3-week cycle (Q3W) until progression.
Receives: Drug: Docetaxel

What is being measured

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

  1. ORR

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

    Measured: Up to approximately 2 years

Secondary outcomes (3)

  1. PFS

    PFS is defined as the time from the date of first dosing 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

  2. 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

  3. Disease control rate

    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

Timeline

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

  1. First posted3 Feb 2021
  2. Study start1 Feb 2021
  3. Primary completionJul 2026 (estimated)
  4. Study completionDec 2026 (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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
265 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04736823
Sponsor's protocol ID
AK112-201
Status last verified
Feb 2026
First submitted
30 Jan 2021
Last updated
2 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhao Y, Chen G, Chen J, Zhuang L, Du Y, Yu Q, Zhuang W, Zhao Y, Zhou M, Zhang W, Zhang Y, Wan Y, Li W, Song W, Wang ZM, Li B, Xia M, Yang Y, Fang W, Huang Y, Zhang L. AK112, a novel PD-1/VEGF bispecific antibody, in combination with chemotherapy in patients with advanced non-small cell lung cancer (NSCLC): an open-label, multicenter, phase II trial. EClinicalMedicine. 2023 Aug 3;62:102106. doi: 10.1016/j.eclinm.2023.102106. eCollection 2023 Aug.

    PubMed 37593227

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AK112, Pemetrexed and Paclitaxel 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 9 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: under way, not looking for participants, as of the sponsor's last update on 2 Mar 2026. 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?

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?

ORR (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 NCT04736823, 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 2 Mar 2026.

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