BridgeMD
New treatment option for NSCLC (Non-small Cell Lung Cancer)
Official title A Study of AK104 in Subjects With Unresectable Locally Advanced NSCLC
ClinicalTrials.gov ID: NCT06617416
What this study is testing
What is Cadonilimab (AK104)?
Cadonilimab (AK104) is an investigational medicine, being studied as a potential treatment for nsclc (non-small cell lung cancer).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people 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.
You likely can't join if
- The histopathology contains any component of small cell lung cancer.
- Currently participating in another treatment 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.
See the full eligibility criteria
- people 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.
- 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.
- The histopathology contains any component of small cell lung cancer.
- Currently participating in another treatment 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Jinan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jinan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.