New Antibody-Chemo cocktail shows promise for tough lung cancers
NCT ID NCT05215067
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase II trial tested a new drug called AK104 (a bispecific antibody that targets two immune checkpoints) combined with the chemotherapy docetaxel in 44 adults with advanced non-small cell lung cancer whose disease had progressed after platinum-based chemotherapy and an anti-PD-1/PD-L1 drug. The study aimed to see if the combination could shrink tumors and control the disease longer. Results are not yet reported, but the approach tries to boost the immune system while directly killing cancer cells.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AK104 (a bispecific antibody targeting PD-1 and CTLA-4) combined with docetaxel chemotherapy
- What this could lead to
- If successful, this combination could offer a new treatment option for people with advanced lung cancer whose disease has worsened after standard therapies.
- What could go wrong
- This is a small, early-phase trial (44 people) with no control group, so results may not be definitive. Side effects from combining immunotherapy and chemotherapy can be serious.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
44 people
The number who actually took part.
- Started
-
May 2022
- Finished
-
Jan 2026
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 18 to 75 years old. 2. Have a life expectancy of at least 3 months. 3. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. Has a histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC. 5. Has radiographic progression after prior platinum doublet chemotherapy and anti-PD-1/PD-L1 monoclonal antibody (mAb) administered. 6. No known epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutations. 7. Has at least 1 measurable lesion per RECIST 1.1 assessed by investigator. 8. Has adequate organ function. Exclusion Criteria: 1. Undergone major surgery within 30 days prior to the first dose of study treatment. 2. Active central nervous system (CNS) metastases. 3. History of active autoimmune disease that has required systemic treatment in the past 2 years (i.e.,corticosteroids or immunosuppressive drugs). 4. Active Hepatitis B or Hepatitis C. 5. Received previous immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy and other treatments targeting the mechanism of tumor immunity. 6. Has received treatment with docetaxel. 7. History of severe bleeding tendency or coagulation disorder.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210009, China
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