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Experimental combo for tough lung cancer hits dead end

NCT ID NCT05636267

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.