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NSCLCPhase 2NCT06448910

Cadonilimab(AK104) Plus Concurrent Chemoradiotherapy in Patients With Locally Advanced, Unresectable, Stage III NSCLC

A Phase 2 study testing Cadonilimab (AK104) in people with NSCLC and Locally Advanced Lung Carcinoma, run by Fudan University 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

The goal of this single arm, phase II clinical trial is to evaluate the efficacy and safety of cadonilimab (AK104) as induction and consolidation therapy in locally advanced/unresectable non-small cell lung cancer (NSCLC) patients treated with concurrent chemoradiotherapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
NSCLC, Locally Advanced Lung Carcinoma
What is being tested?
Cadonilimab (AK104)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
1 siteChina
Study dates
1 Jul 2024to Jun 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: ≥18 years old;
  • ECOG physical status: 0-1;
  • The expected survival time is more than 3 months;
  • Patients with locally advanced/unresectable stage IIIA-C NSCLC confirmed by histopathology or cytology based on the AJCC 8th edition staging system at initial diagnosis；
  • Did not receive any anti-tumor treatment;
  • No known sensitive EGFR/ALK/ROS1 mutations
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  • According to RECIST criteria, at least one measurable lesion must be used as the target lesion
  • Good organ function ≤ 7 days before the first dose of study drug, as indicated by the following laboratory values:
  • Absolute neutrophil count (ANC) ≥1.5 x 109/L, platelet ≥100 x 109/L, hemoglobin ≥90g/L;
  • INR or PT ≤1.5 x ULN;
  • aPTT ≤1.5 x ULN;
  • Total serum bilirubin ≤1.5 x ULN;
  • AST and ALT ≤ 2.5x ULN or ≤5×ULN in patients with liver metastases;
  • albumin ≥25 g/L (2.5 g/dL);
  • Serum creatinine ≤1.5 times the upper limit of normal value (ULN), or serum creatinine clearance calculated by Cockcroft-Gault formula >50 mL/min;
  • Informed consent signed by patients or their legal representatives was obtained, and the study protocol and follow-up procedure were followed.
  • Patients of childbearing potential had to be willing to continue using high-potency contraception for the duration of the study and for ≥120 days after the last dose of Cadonilimab (AK104).

Who cannot join

  • Pathological types of mixed small cell and non-small cell lung cancer;
  • Patients with known EGFR/ALK/ROS1 mutations;
  • Patients have received an approved systemic anticancer therapy or systemic immunomodulatory agent (including, but not limited to, interferon, interleukin-2, and tumor necrosis factor) within 4 weeks before the first dose;
  • Have received a live or attenuated live vaccine within 4 weeks before enrollment or are expected to require a live or attenuated live vaccine during the study or within 5 months after the last dose of Cadonilimab (AK104);
  • Patients allergic to Cadonilimab(AK104) or any of the ingredients, or the container;
  • Untreated patients with chronic hepatitis B or chronic hepatitis B virus carriers with HBV DNA≥500 IU/mL or patients with active hepatitis C:
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  • Patients with inactive HBsAg carriers and medically stable active HBV infection (HBV DNA<500 IU/mL) were eligible. Only to hepatitis b core antibody (anti HBc antibody) patients who tested positive for HBV DNA testing.
  • Patients who were negative for hepatitis C virus (HCV) antibodies at screening or who were positive for HCV antibodies at screening and subsequently tested negative for HCV RNA were eligible. HCV RNA testing will be performed only in patients who are positive for hepatitis C virus (HCV) antibodies.
  • Note: the hepatitis b surface antigen (HBsAg) can be detected or patients with HBV DNA can be detected, should according to the guidelines for treatment. Patients receiving antiviral treatment at screening were supposed to have been on treatment for more than 2 weeks before enrollment and to have continued treatment for 6 months after discontinuation of the study drug.
  • Need systemic treatment of active autoimmune disease, the researchers reckon have an impact on research and treatment of patients;
  • Any condition requiring systemic treatment with a corticosteroid (prednisone or equivalent >10 mg/ day) or other immunosuppressive agent, within 14 days before the first dose of the study drug, that was assessed by the investigator as having an impact on the study treatment;
  • Severe chronic or active infection (including tuberculosis infection, etc.) requiring antimicrobial, antifungal, or antiviral systemic therapy within 14 days prior to the first dose of study drug
  • Always allogeneic stem cell transplantation or organ transplantation;
  • Meet the following any kind of cardiovascular risk factors of standard:
  • Cardiogenic chest pain ≤28 days before the first dose of study drug, defined as moderate pain that limits instrumental exercise of daily living;
  • Symptomatic pulmonary embolism ≤28 days before the first dose of study drug;
  • Any history of acute myocardial infarction ≤6 months before the first dose of study drug;
  • Any history of New York Heart Association (NYHA) class III or IV heart failure ≤6 months before the first dose of study drug;
  • Any ventricular arrhythmic event of grade ≥2 occurred ≤6 months before the first dose of study drug.
  • History of any cerebrovascular accident ≤6 months before the first dose of study drug;
  • Corrected QT interval (QTc) (corrected with Fridericia's method) >450 msec; Note: If the QTc interval on the initial ECG was >450 ms, a subsequent ECG was performed to rule out the result
  • Left ventricular ejection fraction (LVEF) ≤ the lower limit of normal (LLN) as assessed by echocardiography (ECHO);
  • Any syncope or seizure occurring ≤28 days before the first dose of study drug;
  • Patients with uncontrolled hypertension (defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg);
  • Bleeding, thrombotic disorders, or use of an anticoagulant (e.g., warfarin) or similar medication requiring therapeutic INR monitoring within 6 months before the first dose of a study drug that, in the investigator's judgment, may have influenced treatment;
  • Patients with any sign or history of bleeding that was assessed by the investigator as having an impact on the study protocol; Patients who had any bleeding event of grade 3 or higher, nonhealed wound, ulcer, or fracture within 4 weeks before the first dose;
  • Hemoptysis > 50ml/d;
  • The central cavity or tumor was shown to invade or be adjacent to large vessels by imaging studies, and the tumor was assessed by the investigator as likely to invade large vessels and cause fatal bleeding.
  • Unable to swallow capsules or significant influence disease or a history of gastrointestinal function, such as malabsorption syndrome, stomach or intestinal resection, bariatric surgery, with symptoms of inflammatory bowel disease, or incomplete or complete intestinal obstruction.
  • Patients requiring treatment with gastric ph-regulating drugs, including proton pump inhibitors and/or H2 antagonist drugs. Patients can convert antacids;
  • Patients with a history of uncontrolled systemic diseases, including diabetes mellitus, hypertension, pulmonary fibrosis, or acute lung disease, that were assessed by the investigator as having an impact on the study treatment;
  • Patients with a history of major illness or clinical manifestations that may affect the function of organ systems and are considered by the investigator to have an impact on the study treatment;
  • Had undergone any major surgery requiring general anesthesia within 28 days or less before the first dose;
  • There are underlying medical conditions or alcohol/drug abuse or dependence that contraindicate the use of the experimental drug or preclude the administration of the study drug, or may affect the interpretation of the results, or place the patient at a high risk of treatment complications;
  • Known human immunodeficiency virus (HIV) infection;
  • Any activity before the group 2 years or less malignant tumor, except in the study of the specific cancer and any local recurrence has been cured of cancer (such as removal of basal cell or squamous cell cancer, superficial bladder cancer, cervical or breast carcinoma in situ);
  • Pregnant or lactating women, or male and female patients who plan to have a child during the study period;
  • Participate in another therapeutic clinical study at the same time, unless it is an observational (nonintervention) clinical study or is in the follow-up period of an intervention study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai

Other trials in China

About this study

Official title: Lung-AK104 Study: Cadonilimab(AK104) Plus Concurrent Chemoradiotherapy in Patients With Locally Advanced, Unresectable, Stage Lll Non-Small Cell Lung Cancer

The goal of this single arm, phase II clinical trial is to evaluate the efficacy and safety of cadonilimab (AK104) as induction and consolidation therapy in locally advanced/unresectable non-small cell lung cancer (NSCLC) patients treated with concurrent chemoradiotherapy.

Participants will receive 2 cycles of induction therapy with cadonilimab combined with carboplatin/cisplatin plus etoposide, followed by standard concurrent chemoradiotherapy (thoracic radiotherapy + carboplatin/cisplatin plus etoposide regimen chemotherapy), and finally consolidation therapy with cadonilimab (AK104) for 1 year.

Being tested
Cadonilimab (AK104)

What participants receive

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

  • Cadonilimab (AK104)Drug

    Also called Concurrent Chemoradiotherapy

    Participants will receive 2 cycles of induction therapy with cadonilimab combined with carboplatin/cisplatin plus etoposide, followed by standard concurrent chemoradiotherapy (thoracic radiotherapy + carboplatin/cisplatin plus etoposide), and finally consolidation therapy with cadonilimab (AK104) for 1 year.

Study groups in NCT06448910
Study groupRoleWhat they receive
Cadonilimab plus concurrent chemoradiotherapyExperimentalNot described
Receives: Drug: Cadonilimab (AK104)

What is being measured

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

  1. Objective response rate，ORR

    According to RECISIT1.1 criteria, the proportion of patients achieving CR and PR as their best response before initial disease progression was evaluated.

    Measured: 3 years

  2. The incidence rate of treatment-related adverse events

    The proportion of treatment-related toxicity to the total number of evaluable cases was evaluated according to CTCAE 5.0 criteria.

    Measured: 3 years

Secondary outcomes (5)

  1. ORR before Concurrent Chemoradiotherapy

    Objective response rate was evaluated according to RECIST 1.1 criteria after two courses of Cadonilimab combined with EP chemotherapy and before the start of concurrent chemoradiotherapy

    Measured: 3 years

  2. disease control rate before Concurrent Chemoradiotherapy

    Disease control rate was evaluated according to RECIST 1.1 criteria after two courses of AK104 combined with EP chemotherapy and before the start of concurrent chemoradiotherapy

    Measured: 3 years

  3. Overall survival，OS

    The time from enrollment to death from any cause. Patients who were still alive at the time of analysis will have the date of their last contact as the cutoff date.

    Measured: 3 years

  4. Progression free survival，PFS

    The time from enrollment to disease progression or death from any cause. Patients who were still alive at the time of analysis will have the date of their last contact as the cutoff date.

    Measured: 3 years

  5. 12 months PFS

    The proportion of patients who had progression or died from any cause from the first day of enrollment through 12 months among all participants who received at least one dose of Cadonilimab.

    Measured: 3 years

Timeline

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

  1. First posted7 Jun 2024
  2. Study start1 Jul 2024
  3. Primary completionOct 2025 (estimated)
  4. Study completionJun 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
41 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06448910
Sponsor's protocol ID
Lung-AK104
Status last verified
Sep 2025
First submitted
4 Jun 2024
Last updated
24 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cadonilimab (AK104) in people with NSCLC and Locally Advanced Lung Carcinoma, run by Fudan 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 17 inclusion and 38 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 24 Sep 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?

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: 3 years). The study lists 2 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 NCT06448910.

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 24 Sep 2025.

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