Experimental combo for tough lung cancer hits dead end
NCT ID NCT05636267
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study tested two immunotherapy drugs, AK119 and AK112, with or without chemotherapy, in 59 people with a specific type of advanced lung cancer (EGFR-mutant non-squamous NSCLC) that had stopped responding to standard targeted pills. The goal was to see if the combination was safe and could shrink tumors. However, the trial was terminated early, so we don't have full results on how well it worked.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AK119 and AK112 (immunotherapy drugs) with or without chemotherapy (pemetrexed and carboplatin)
- What this could lead to
- If successful, this could offer a new treatment option for people with a specific type of lung cancer that stopped responding to standard targeted therapy.
- What could go wrong
- This trial was terminated early, so results are limited. It was also a small, early-phase study, so even if data were available, much more research would be needed to confirm any benefit.
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
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
59 people
The number who actually took part.
- Started
-
Feb 2023
- Finished
-
Apr 2025
- 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.
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: 1. Be able to understand and voluntarily sign the written informed consent, which must be signed before the designated research procedure. 2. Age ≥ 18 and ≤ 75, male or female. 3. Local advanced or metastatic non-squamous NSCLC confirmed by histology or cytology according to eighth edition of the TNM classification for lung cancer. 4. EGFR activating mutation confirmed by tumor histology, cytology or hematology. 5. Failed to previous EGFR-TKI treatment. 6. ECOG performance status 0 to1. 7. Life expectancy ≥3 months. 8. At least one measurable lesion according to RECIST v1.1. 9. Adequate organ function. Exclusion Criteria: 1. Histological or cytological pathology confirmed the presence of small cell carcinoma or squamous cell carcinoma. 2. Have suffered from the second primary active malignant tumor in the past 3 years. 3. There are other driving gene mutations that can obtain effective treatment. 4. Receipt of the following treatments or procedures: immunotherapy, including immunocheckpoint inhibitors, immunocheckpoint agonists, immunocellular therapy, and any other treatment targeting tumor immune mechanism; systematic chemotherapy in the advanced stage (IIIB-IV); anti-angiogenesis drugs, except for small molecule anti-angiogenesis drugs with drug withdrawal more than 4 weeks; extensive radiotherapy within 4 weeks; EGFR-TKIs within 2 weeks. 5. Symptomatic central nervous system metastases. 6. The toxicity of previous anti-tumor therapy has not been alleviated. 7. Uncontrolled massive ascites, pleural effusion or pericardial effusion. 8. Active autoimmune diseases in the past 2 years. 9. History of interstitial lung disease or noninfectious pneumonitis. 10. Suffering from clinically significant cardiovascular or cerebrovascular diseases. 11. History of severe bleeding tendency or coagulation dysfunction. 12. History of deep vein thrombosis, pulmonary embolism or any other serious thromboembolism in the past 3 months. 13. Serious infection in the past 4 weeks. 14. Acute exacerbation of chronic obstructive pulmonary disease or asthma in the past 4 weeks. 15. History of human immunodeficiency virus (HIV) infection. 16. History of severe hypersensitivity reactions to other mAbs. 17. History of organ transplantation. 18. Any other conditions that, in the opinion of the investigator, may increase the risk when receiving the investigational product.
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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
-
Guangdong Provincial People's Hospital
Guangzhou, China
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Other studies related to the condition(s) this trial covers.
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