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Resectable Non-small Cell Lung CancerPhase 2NeoadjuvantNCT06946836

Comparison of Neoadjuvant Cadonilimab Versus Chemotherapy Combined With PD-1 in the Treatment of Resectable Non-Small Cell Lung Cancer With High PD-L1 Expression: A Single-Center, Randomized, Exploratory Clinical Study

A Phase 2 study testing AK104 in people with Resectable Non-small Cell Lung Cancer and Bispecific Antibody, run by Shanghai Pulmonary Hospital, Shanghai, China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The advent of immunotherapy has changed the treatment landscape for patients with non-small cell lung cancer. It has become the mainstay of perioperative treatment for patients with resectable non-small cell lung cancer。 Cadonilimab is the world's first bispecific antibody drug targeting PD-1 and CTLA-4. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
AK104
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
No sites listed yet
Study dates
21 Apr 2025to 11 May 2031
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient shall sign the Informed Consent Form.
  • Aged 18 ≥ years.
  • Histological or cytological diagnosis of NSCLC by needle biopsy, and stage IB-IIIA confirmed by imageological examinations (CT, PET-CT or EBUS) and Treatment-naïve for relevant antitumor therapy .
  • Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1.
  • Life expectancy is at least 12 weeks.
  • At least 1 measurable lesion according to RECIST 1.1.
Show all 11Show fewer
  • Patients with good function of other main organs (liver, kidney, blood system, etc.)
  • Patients with lung function can tolerate surgery;
  • Without systematic metastasis (including M1a, M1b and M1c);
  • Fertile female patients must voluntarily use effective contraceptives not less than 120 days after chemotherapy or the last dose of serplulimab (whichever is later) during the study period, and urine or serum pregnancy test results within 7 days prior to enrollment are negative.
  • Unsterilized male patients must voluntarily use effective contraception during the study period not less than 120 days after chemotherapy or the last dose of serplulimab (whichever is later).

Who cannot join

  • 1.Histology suggestive of small cell component and Participants who have received any systemic anti-cancer treatment for thymic epithelial tumor, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment; 2. Participants with any unstable systemic disease (including active infection, uncontrolled hypertension), unstable angina pectoris, angina pectoris starting in the last three months, congestive heart failure (>= NYHA) Grade II), myocardial infarction (6 months before admission), severe arrhythmia requiring drug treatment, liver, kidney or metabolic diseases; 3. With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment; 4. Participants who are allergic to the test drug or any auxiliary materials; 5. Participants with Interstitial lung disease currently; 6. Participants with active hepatitis B, hepatitis C or HIV; 7. Pregnant or lactating women; 8. Participants suffering from nervous system diseases or mental dieases that cannot cooperate; 9.Participated in another therapeutic clinical study; Other factors that researchers think it is not suitable for enrollment.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Peng Zhang Peng Zhang, PhD contact

02165115006

zhangpeng1121@tongji.edu.cn

About this study

The advent of immunotherapy has changed the treatment landscape for patients with non-small cell lung cancer. It has become the mainstay of perioperative treatment for patients with resectable non-small cell lung cancer。 Cadonilimab is the world's first bispecific antibody drug targeting PD-1 and CTLA-4. Previous studies on AK104 have demonstrated preliminary efficacy in both treatment-naïve advanced NSCLC patients and immunotherapy-resistant patients, showing a favorable safety and tolerability profile. This study aims to evaluate the effectiveness of neoadjuvant bispecific antibody AK104 compared with neoadjuvant chemotherapy combined with a PD-1 inhibitor in the treatment of resectable non-small cell lung cancer (NSCLC) with high PD-L1 expression.

Read the detailed description

The advent of immunotherapy has changed the treatment landscape for patients with non-small cell lung cancer. It has become the mainstay of perioperative treatment for patients with resectable non-small cell lung cancer。 Cadonilimab is the world's first bispecific antibody drug targeting PD-1 and CTLA-4. Previous studies on AK104 have demonstrated preliminary efficacy in both treatment-naïve advanced NSCLC patients and immunotherapy-resistant patients, showing a favorable safety and tolerability profile. This study aims to evaluate the effectiveness of neoadjuvant bispecific antibody AK104 compared with neoadjuvant chemotherapy combined with a PD-1 inhibitor in the treatment of resectable non-small cell lung cancer (NSCLC) with high PD-L1 expression.

Being tested
AK104
Keywords
Resectable non-small cell lung cancer, bispecific antibody, Neoadjuvant therapy

What participants receive

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

  • AK104Drug

    Also called PD-1 combined with chemotherapy

    Eligible patients will be randomly assigned in a 1:1 ratio to either the PD-1 combined with chemotherapy group or the AK104 monotherapy group. Treatment will be administered every 3 weeks, with patients undergoing three preoperative treatment cycles before surgery.

Study groups in NCT06946836
Study groupRoleWhat they receive
AK104 monotherapy PD-1 combined with chemotherapyExperimentalEnrolled patients will receive 3 cycles of AK104 monotherapy as neoadjuvant treatment, administered every 21 days.
Receives: Drug: AK104

What is being measured

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

  1. PCR

    a complete absence of viable tumor cells in the primary tumor site and surgically removed lymph nodes after neoadjuvant treatment

    Measured: up to 60 months

Secondary outcomes (7)

  1. MPR

    ≤10% residual viable tumor cells in the lung and sampled lymph nodes

    Measured: up to 60 months

  2. ORR

    a partial or complete response according to RECIST, version 1.1

    Measured: up to 60 months

  3. OS

    the time from randomization to death from any cause

    Measured: up to 60 months

  4. EFS

    the time from randomization to progression of disease, recurrence of disease, or death from any cause.

    Measured: up to 60 months

  5. Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0

    Incidence of serious adverse events (SAEs) occurring during treatment according to NCI-CTCAE v5.0

    Measured: up to 60 months

  6. R0 rate

    Proportion of patients achieving R0 resection

    Measured: up to 60 months

  7. Conversion rate of surgery

    Conversion rate from initially unresectable to resectable NSCLC following neoadjuvant therapy

    Measured: up to 60 months

Timeline

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

  1. First posted27 Apr 2025
  2. Study start21 Apr 2025 (estimated)
  3. Primary completion1 May 2031 (estimated)
  4. Study completion11 May 2031 (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
Sequential
Model description
Eligible patients will be randomly assigned in a 1:1 ratio to either the immunotherapy-combined chemotherapy group or the AK104 monotherapy group. Treatment will be administered every 3 weeks, with patients undergoing three preoperative treatment cycles before surgery.
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06946836
Sponsor's protocol ID
LungMate-027
Acronym
Neoadjuvant
Status last verified
Apr 2025
First submitted
19 Apr 2025
Last updated
27 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The researchers will consider whether IPD is available to other researchers only after the paper is published.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AK104 in people with Resectable Non-small Cell Lung Cancer and Bispecific Antibody, run by Shanghai Pulmonary Hospital, Shanghai, 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 1 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: opening soon, as of the sponsor's last update on 27 Apr 2025. 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?

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 Peng Zhang Peng Zhang, PhD (02165115006, zhangpeng1121@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PCR (time frame: up to 60 months). 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 NCT06946836.

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 27 Apr 2025.

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