AzTrials
AzTrials

Carcinoma, Non-Small-Cell LungPhase 2ACHELOUSNCT06001151

Cadonilimab (AK104) Plus Chemotherapy as First-line Treatment in Non-squamous Non-Small Cell Lung Cancer (NSCLC) Patients With Programmed Cell Death Ligand 1 (PD-L1) Negative

A Phase 2 study testing Cadonilimab, Pemetrexed and Carboplatin in people with Carcinoma, Non-Small-Cell Lung, run by Qian Chu 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
Search all trials

Trial summary

This is a single arm, multi-center clinical trial. Target population is advanced or metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC) Patients with Programmed Cell Death Ligand 1 (PD-L1) negative, aiming to evaluate the efficacy and safety of the combination therapy of Cadonilimab and chemotherapy. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
Cadonilimab, Pemetrexed and Carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
1 siteChina
Study dates
7 Aug 2023to 31 Aug 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

  • Patients with histologically/cytologically stage IIIB, IIIC, IV non-squamous Non-Small Cell Lung Cancer (NSCLC)
  • PD-L1 TPS<1%
  • Life expectancy more than 3 months
  • Without EGFR-sensitive mutation (19Exon del/21Exon L858R), ALK, ROS1 gene rearrangement or fusion
  • Has no prior systemic therapy; (chemotherapy and/or radiotherapy is allowed as part of neoadjuvant/adjuvant therapy. Patients who have had recurrence or metastasis for more than 6 months from the end of neoadjuvant/adjuvant treatment would be enrolled)
  • ECOG score 0-1
Show all 10Show fewer
  • Patients must have at least one measurable lesion according to RECIST 1.1
  • Has adequate organ function
  • Agree to provide tumour tissue samples for biomarker exploration (including but not limited to PD-L1 IHC or NGS testing)
  • Voluntarily sign a written informed consent form

Who cannot join

  • Histological examination with Small Cell Lung Cancer or squamous Non-Small Cell Lung Cancer
  • With active central nervous system (CNS) metastases confirmed by CT or MRI
  • With other malignancy within 3 years before enrollment
  • With severe infections within 4 weeks of the first dose of study treatment
  • Women who are pregnant or lactating
  • History of interstitial lung disease, drug-induced interstitial lung disease, or radiation pneumonia requiring hormone therapy
Show all 13Show fewer
  • History of myocarditis, cardiomyopathy, and malignant arrhythmia
  • Tumor compresses important surrounding organs (such as the esophagus) with accompanying symptoms, compressing the superior vena cava or invading the mediastinal vessels, heart, etc.
  • Risk of bleeding, major hemoptysis, or with history of coagulation dysfunction
  • Active autoimmune diseases that require systematic treatment within 2 years before enrollment
  • History of Human Immunodeficiency Virus (HIV)
  • With active hepatitis B infection
  • With uncontrollable pleural effusion, pericardial effusion, or ascites that require repeated drainage

Trial locations and contacts

1 site in 1 country.

China1 site

  • Qian Chu

    Wuhan, Hubei, 430030

Other trials in China

About this study

Official title: Cadonilimab (AK104) Plus Chemotherapy as First-line Treatment in Non-squamous Non-Small Cell Lung Cancer (NSCLC) Patients With Programmed Cell Death Ligand 1 (PD-L1) Negative：A Multi-center, Single-arm, Phase II Study

This is a single arm, multi-center clinical trial. Target population is advanced or metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC) Patients with Programmed Cell Death Ligand 1 (PD-L1) negative, aiming to evaluate the efficacy and safety of the combination therapy of Cadonilimab and chemotherapy. Cadonilimab is a PD-1/CTLA-4 bi-specific antibody.

Read the detailed description

This trial enrolled advanced or metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC) Patients with Programmed Cell Death Ligand 1 (PD-L1) negative. Patients will receive cadonilimab (10mg/kg) plus pemetrexed(500mg/m2) and carboplatin (AUC=5) every 3 weeks for 4 cycles, follwed with cadonilimab (10mg/kg) plus pemetrexed (500mg/m2) every 3 weeks as maintenance therapy. The primary endpoint is 12-month progression-free-survival (PFS) rate assessed by investigators. Key secondary endpoints include objective response rate (ORR), duration of response (DOR), disease control rate (DCR), time to response (TTR), progression free survival (PFS), overall survival (OS), and safety.

Being tested
Cadonilimab, Pemetrexed, Carboplatin
Keywords
non-squamous Non-Small Cell Lung Cancer, Programmed Cell Death Ligand 1, cadonilimab
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.

  • CadonilimabDrug

    Also called AK104

    Patients receive cadonilimab (10mg/kg) every 3 weeks.

  • PemetrexedDrug

    Patients receive pemetrexed (500mg/m2) every 3 weeks.

  • CarboplatinDrug

    Patients receive carboplatin (AUC=5) every 3 weeks for 4 cycles.

Study groups in NCT06001151
Study groupRoleWhat they receive
Experimental ArmExperimentalPatients will receive cadonilimab (10mg/kg) plus pemetrexed(500mg/m2) and carboplatin (AUC=5) every 3 weeks for 4 cycles, follwed with cadonilimab (10mg/kg) plus pemetrexed (500mg/m2) every 3 weeks as maintenance therapy.
Receives: Drug: Cadonilimab; Drug: Pemetrexed; Drug: Carboplatin

What is being measured

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

  1. 12-month progression-free-survival (PFS) rate

    Rate of patients with complete/partial response at 12-month from enrollment

    Measured: At 12 months

Secondary outcomes (7)

  1. objective response rate (ORR)

    objective response rate using RECIST 1.1 criteria

    Measured: about 24 months

  2. duration of response (DOR)

    Time from the date of the first documented response (CR or PR) to the earliest date of disease progression (RECIST 1.1), or death due to any cause

    Measured: about 24 months

  3. disease control rate (DCR)

    disease control rate using RECIST 1.1 criteria

    Measured: about 24 months

  4. time to response (TTR)

    Time from the date of enrollment to the first documented response (CR or PR) (RECIST 1.1)

    Measured: about 24 months

  5. progression free survival (PFS)

    Time from enrollment to first observation of progression (RECIST1.1) or date of death (from any cause)

    Measured: about 24 months

  6. overall survival (OS)

    Time from enrollment until death due to any cause

    Measured: about 24 months

  7. incidence, type and severity of adverse events

    Descriptive statistics of safety will be presented using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0

    Measured: From time of informed consent through treatment period and up to 30 days post last dose of study treatment (about 24 months)

Timeline

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

  1. First posted21 Aug 2023
  2. Study start7 Aug 2023
  3. Primary completion31 Aug 2025
  4. Study completion31 Aug 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
49 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06001151
Sponsor's protocol ID
S019
Acronym
ACHELOUS
Status last verified
Oct 2026
First submitted
12 Aug 2023
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cadonilimab, Pemetrexed and Carboplatin in people with Carcinoma, Non-Small-Cell Lung, run by Qian Chu 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 10 inclusion and 13 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 16 Oct 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?

12-month progression-free-survival (PFS) rate (time frame: At 12 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 NCT06001151.

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 16 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in