New drug combo aims to shrink tough lung tumors
NCT ID NCT05904379
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests two experimental immunotherapy drugs, AK112 and AK104, given together with or without standard chemotherapy. The goal is to see if this combination can safely shrink tumors and control advanced non-small cell lung cancer. About 233 adults with stage IIIB/IV lung cancer who cannot have curative treatment are taking part.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AK112 and AK104 (immunotherapy drugs), with or without chemotherapy (carboplatin, paclitaxel, pemetrexed, or docetaxel)
- What this could lead to
- If successful, this combination could offer a new treatment option that helps shrink tumors and control advanced lung cancer for longer.
- What could go wrong
- This is an early-phase trial (Phase 1/2) with a small number of participants, so results may not apply to all patients. Side effects from 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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 233 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2023
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Has a histologically or cytologically confirmed diagnosis of NSCLC. * Has Stage IIIB/C or IV NSCLC (American Joint Committee on Cancer \[AJCC 8th\]). * 18-75 years old (at the time consent is obtained). * Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures). * Be able to provide formalin fixed, paraffin-embedded (FFPE) tumor tissue. * Has a life expectancy of at least 3 months. * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as determined by the site study team. * Has no EGFR-sensitive mutations or ALK gene translocations. * Has adequate organ function. * Has recovered from the effects of any prior radiotherapy or surgery. * All female and male subjects of reproductive potential must agree to use an effective method of contraception, during and for 120 days after the last dose of study treatment. Exclusion Criteria: * Has any histologically small cell carcinoma component. * Is currently participating in a study of an investigational agent or using an investigational device. * Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy within 2 years prior to the first dose of study treatment. * Has undergone major surgery within 30 days of Study Day 1. * Has a known additional malignancy that is progressing or requires systemic treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. * Has known active central nervous system (CNS) metastases. * Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). * Has an active infection requiring systemic therapy. * Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected). * Has a history of myocardial infarction, unstable angina, congestive heart failure within 12 months prior to day 1 of study treatment. * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of this subject to participate, in the opinion of the treating investigator. * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study. * Has received a live virus vaccine within 30 days of the planned first dose of study therapy. * Has any concurrent medical condition that, in the opinion of the Investigator, would complicate or compromise compliance with the study or the well-being of the subject.
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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
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Shanghai Pulmonary Hospital
Shanghai, China
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Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a Triple-Drug combo outsmart Immunotherapy-Resistant lung cancer?