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Resectable Non-small Cell Lung CancerPhase 2NCT05247684

AK112 Neoadjuvant/Adjuvant Treatment for Resectable NSCLC

A Phase 2 study testing AK112, Carboplatin and Cisplatin in people with Resectable Non-small Cell Lung Cancer, 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

AK112, alone or in combination with chemotherapy for the neoadjuvant/adjuvant treatment of resectable NSCLC Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Resectable Non-small Cell Lung Cancer
What is being tested?
AK112, Carboplatin and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteChina
Study dates
20 Feb 2022to 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
  • Be able and willing to provide written informed consent and to comply with all requirements of study participation
  • Histologically confirmed resectable stage II-IIIB NSCLC
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • 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 an active autoimmune disease that has required systemic treatment in the past 2 years
  • 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)
  • 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

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality

Other trials in China

About this study

Official title: Phase II Clinical Study of AK112, an Anti-PD-1 and VEGF Bispecific Antibody, Alone or in Combination With Chemotherapy for the Neoadjuvant/Adjuvant Treatment of Resectable Non-small Cell Lung Cancer

AK112, alone or in combination with chemotherapy for the neoadjuvant/adjuvant treatment of resectable NSCLC

Read the detailed description

Phase II clinical study of AK112, an anti-PD-1 and VEGF bispecific antibody, alone or in combination with chemotherapy for the neoadjuvant/adjuvant treatment of resectable non-small cell lung cancer

Being tested
AK112, Carboplatin, Cisplatin, Paclitaxel

What participants receive

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

Study groups in NCT05247684
Study groupRoleWhat they receive
arm 1(AK112)ExperimentalNeoadjuvant therapy was 3-4 cycles of AK112(Q3W), followed by surgery ,followed by adjuvant therapy for 16 cycles of AK112(Q3W)
Receives: Drug: AK112
arm 2(AK112+Carboplatin/cisplatin + paclitaxel)ExperimentalNeoadjuvant therapy was 3-4 cycles of AK112 plus Carboplatin/cisplatin + paclitaxel(Q3W), followed by surgery ,followed by adjuvant therapy for 16 cycles of AK112(Q3W)
Receives: Drug: AK112; Drug: Carboplatin; Drug: Cisplatin; Drug: Paclitaxel

What is being measured

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

  1. Incidence and severity of adverse events (AE)

    Summary of AE incidence; summary after grading of AE according to NCI CTCAE version 5.0

    Measured: Up to approximately 2 years

  2. Rate of surgical delays

    Proportion of subjects exceeding the maximum surgical time window

    Measured: Up to approximately 2 years

  3. Abnormal laboratory findings of clinical significance

    Proportion of subjects with abnormal and clinically significant results including routine blood tests, blood biochemical tests, coagulation tests, thyroid function tests, routine urine tests, pregnancy tests, etc.

    Measured: Up to approximately 2 years

  4. Major pathological response (MPR)

    Proportion of subjects with ≤10% residual live tumor cells in resected primary tumor and lymph nodes

    Measured: Up to approximately 2 years

Secondary outcomes (6)

  1. R0 resection rate

    Proportion of subjects with pathologically complete resection of primary tumors

    Measured: Up to approximately 2 years

  2. Tumor descending stage rate

    Proportion of subjects with the most recent tumor staging prior to surgery (using TNM staging version 8) who were down-staged relative to baseline

    Measured: Up to approximately 2 years

  3. Pathological complete response (pCR)

    Proportion of subjects with no residual tumor in the resected primary tumor and lymph nodes

    Measured: Up to approximately 2 years

  4. Overall survival (OS)

    Time from first dose until death from any cause

    Measured: Up to approximately 2 years

  5. Event free survival (EFS)

    Time from first dose to the occurrence of any of the following events, whichever occurs first: disease progression, local recurrence or distant metastasis or death from any cause, as assessed according to RECIST v1.1.

    Measured: Up to approximately 2 years

  6. Objective response rate (ORR)

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

    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 posted21 Feb 2022
  2. Study start20 Feb 2022
  3. Primary completion18 Aug 2025
  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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05247684
Sponsor's protocol ID
AK112-205
Status last verified
Mar 2026
First submitted
19 Jan 2022
Last updated
29 Jul 2026
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 AK112, Carboplatin and Cisplatin in people with Resectable Non-small Cell Lung Cancer, 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 6 inclusion and 7 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 29 Jul 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?

Incidence and severity of adverse events (AE) (time frame: Up to approximately 2 years). The study lists 4 primary outcomes in all. 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 NCT05247684.

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 29 Jul 2026.

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