NSCLC (Non-small Cell Lung Cancer)Phase 3NCT06617416
A Study of AK104 in Subjects With Unresectable Locally Advanced NSCLC
A Phase 3 study testing Cadonilimab (AK104) and Sugemalimab in people with NSCLC (Non-small Cell Lung Cancer), run by Akeso at 1 site in China.
Trial summary
This study compares the efficacy and safety of AK104 versus Sugemalimab as consolidation therapy in patients with unresectable, locally advanced NSCLC who have not progressed following concurrent or sequential chemoradiotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC (Non-small Cell Lung Cancer)
- What is being tested?
- Cadonilimab (AK104) and Sugemalimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 1 siteChina
- Study dates
- 12 Nov 2024to 30 Dec 2028
- Phase
- Phase 3
- 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
- Subjects must sign the written informed consent form (ICF) voluntarily.
- Age ≥18 years.
- Histologically or cytologically confirmed unresectable locally advanced (Stage III) NSCLC.
- Absence of known EGFR sensitive mutations and negative for ALK and ROS1 fusions.
- Concurrent or sequential chemoradiotherapy completed 1 to 42 days prior to the first dose.
- Chemotherapy regimens should be in accordance with current clinical guidelines.
Show all 12Show fewer
- Consolidation chemotherapy is not allowed after radiotherapy.
- Total dose of radiotherapy is 60Gy±10% (54Gy-66Gy).
- No disease progression after concurrent or sequential chemoradiotherapy.
- ECOG performance status score of 0-1.
- Expected survival of over 3 months.
- Adequate organ and bone marrow function.
Who cannot join
- The histopathology contains any component of small cell lung cancer.
- Currently participating in another interventional clinical study.
- Previously received immunotherapy, biotherapy, anti-angiogenic drugs, or small molecule targeted drugs.
- Patients with clinically significant cardio-cerebrovascular or venous thromboembolic diseases.
- Prior malignancy active within the previous 3 years except for the locally curable cancers that have been apparently cured.
- Tumor invades important vessels or organs.
Show all 15Show fewer
- Experienced acute exacerbation of chronic obstructive pulmonary disease or asthma within 4 weeks prior to the first dose.
- Presence of interstitial lung disease that requires treatment.
- Toxicities of prior anticancer therapy have not resolved to ≤ Grade 1 (NCI-CTCAE version 5.0).
- Experienced severe infection within 4 weeks prior to the first dose.
- Underwent major surgery or experienced severe trauma within 4 weeks prior to the first dose.
- Any condition that required systemic treatment with corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive agents within 14 days prior to the first dose.
- Active autoimmune diseases or history of autoimmune diseases that may relapse.
- Previous history of severe hypersensitivity reactions to other monoclonal antibodies.
- Previous organ transplantation or allogeneic hematopoietic stem cell transplantation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital of Shandong First Medical University
Jinan
Jinming Yu, MD, +86-0531-87984777, sdzlllh803@126.com
About this study
Official title: A Randomized, Double-blind, Multicenter Phase III Study to Evaluate the Consolidation Therapy of AK104 Versus Sugemalimab in Patients With Unresectable Locally Advanced Non-Small Cell Lung Cancer Who Have Not Progressed After Concurrent or Sequential Chemoradiotherapy
This study compares the efficacy and safety of AK104 versus Sugemalimab as consolidation therapy in patients with unresectable, locally advanced NSCLC who have not progressed following concurrent or sequential chemoradiotherapy.
- Conditions
- NSCLC (Non-small Cell Lung Cancer)
- Being tested
- Cadonilimab (AK104), Sugemalimab
- 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.
Cadonilimab (AK104)Drug
AK104 ivgtt Q3W
SugemalimabDrug
1200mg Q3W
| Study group | Role | What they receive |
|---|---|---|
| AK104 group | Experimental | AK104 Q3W Receives: Drug: Cadonilimab (AK104) |
| Sugemalimab group | Active comparator | Sugemalimab 1200mg Q3W Receives: Drug: Sugemalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) assessed by INV
PFS is defined as the time from randomization until the first documentation of disease progression or death due to any cause, whichever occurs first (based on RECIST Version 1.1).
Measured: 3 years
Secondary outcomes (3)
OS
Time from randomization to death
Measured: 5 years
6-month PFS rate assessed by INV
PFS rate at 6 months
Measured: 3 years
AEs
Adverse events incidence and severity, clinically significant abnormal laboratory test results.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start12 Nov 2024
- Primary completion28 Oct 2026 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC (Non-small Cell Lung Cancer)Studies of the same condition, open and under way.
- More trials run by AkesoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jinming Yu, MD, Principal investigator, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06617416
- Sponsor's protocol ID
- AK104-309
- Status last verified
- Mar 2025
- First submitted
- 25 Sep 2024
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multicenter Phase III Study to Evaluate the Consolidation Therapy of AK104 Versus Sugemalimab in Patients With Unresectable Locally Advanced Non-Small Cell Lung Cancer Who Have Not Progressed After Concurrent or Sequential Chemoradiotherapy
- ClinicalTrials.gov ID
- NCT06617416
- Acronym / sponsor ID
- AK104-309
- Conditions
- NSCLC (Non-small Cell Lung Cancer)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- 28 Oct 2026 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 27 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compares the efficacy and safety of AK104 versus Sugemalimab as consolidation therapy in patients with unresectable, locally advanced NSCLC who have not progressed following concurrent or sequential chemoradiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AK104 group | Experimental | Drug: Cadonilimab (AK104)AK104 Q3W |
| Sugemalimab group | Active comparator | Drug: SugemalimabSugemalimab 1200mg Q3W |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subjects must sign the written informed consent form (ICF) voluntarily.
- Age ≥18 years.
- Histologically or cytologically confirmed unresectable locally advanced (Stage III) NSCLC.
- Absence of known EGFR sensitive mutations and negative for ALK and ROS1 fusions.
- Concurrent or sequential chemoradiotherapy completed 1 to 42 days prior to the first dose.
Key exclusion criteria (15 listed)
- The histopathology contains any component of small cell lung cancer.
- Currently participating in another interventional clinical study.
- Previously received immunotherapy, biotherapy, anti-angiogenic drugs, or small molecule targeted drugs.
- Patients with clinically significant cardio-cerebrovascular or venous thromboembolic diseases.
- Prior malignancy active within the previous 3 years except for the locally curable cancers that have been apparently cured.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cadonilimab (AK104)AK104 ivgtt Q3W | Drug | AK104 group |
| Sugemalimab1200mg Q3W | Drug | Sugemalimab group |
Primary outcome
Progression-free survival (PFS) assessed by INV
Time frame: 3 years
PFS is defined as the time from randomization until the first documentation of disease progression or death due to any cause, whichever occurs first (based on RECIST Version 1.1).
3 secondary outcomes
OS
Time frame: 5 years
6-month PFS rate assessed by INV
Time frame: 3 years
AEs
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for NSCLC (Non-small Cell Lung Cancer)
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jinming Yu, MD principal investigator
Shandong Cancer Hospital and Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cadonilimab (AK104) and Sugemalimab in people with NSCLC (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 12 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 12 Mar 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Ting Liu, MD (+86-0760-89873925, clinicaltrials@akesobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) assessed by INV (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2025.