New hope for lung cancer patients who failed targeted treatment?
NCT ID NCT07158840
First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 2 times
Summary
This study tests a drug called AK112 in 60 people with a certain type of advanced lung cancer (non-squamous non-small cell lung cancer) that has specific genetic changes and has stopped responding to previous targeted therapy. The main goal is to see how many patients' tumors shrink or disappear. Researchers will also track how long patients live and how long the cancer stays under control.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AK112 (a drug that helps the immune system fight cancer)
- What this could lead to
- If successful, this could offer a new treatment option for people with a specific type of lung cancer who have stopped responding to standard targeted therapy.
- What could go wrong
- This is an early Phase 2 trial with only 60 participants, so results may not apply to everyone. The drug may not work or could cause side effects.
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
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2025
An estimate. Start dates often move.
- Expected to finish
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Jun 2029
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: 1. Signed the Informed Consent Form (ICF) voluntarily。 2. Participants must be aged between 18 and 75 years (inclusive), regardless of gender. 3. ECOG performance status of 0 or 1. 4. With a life expectancy of ≥3 months. 5. Histologically or cytologically confirmed locally advanced (stage IIIB/IIIC) or metastatic (stage IV) non-squamous NSCLC. 6. Prior to enrollment, participants must have at least one actionable genomic alteration (AGA) confirmed by tumor histology, cytology, or blood-based testing, including: EGFR, ALK, ROS1, NTRK, RET, BRAF and MET. Participants must provide a prior AGA test report; otherwise, AGA testing must be performed at the study site or at a site-designated laboratory before enrollment. 7. Previous treatment failure with an AGA-targeted TKI. 8. At least one measurable extracranial lesion as defined by RECIST v1.1. 9. Adequate organ function confirmed. Exclusion Criteria: 1. Histological or cytological pathology confirming the presence of a small-cell carcinoma component or a predominant squamous cell carcinoma component. 2. AGA test report showing the presence of a common EGFR sensitizing mutation. 3. Prior receipt of immunotherapy. 4. Prior receipt of any systemic anti-tumor therapy for advanced-stage (IIIB-IV) NSCLC other than AGA-targeted TKIs. 5. Concurrent participation in another clinical study, unless it is a non-interventional study or the follow-up phase of an interventional study. 6. Receipt of AGA-targeted TKI therapy within 2 weeks prior to the first dose; receipt of non-specific immunomodulatory therapy within 2 weeks prior to the first dose. 7. Imaging during the screening period shows tumor encasement of major blood vessels or significant necrosis/cavitation, and the investigator determines that study participation would pose a bleeding risk. 8. Imaging during the screening period shows tumor invasion of surrounding vital organs or blood vessels. 9. Central nervous system metastases: participants assessed by the investigator as not requiring local treatment may be eligible; leptomeningeal metastases are not eligible. 10. History of malignancy other than NSCLC within 3 years prior to the first dose; participants with other malignancies that have been cured by local treatment are allowed. 11. Active autoimmune disease requiring systemic therapy within 2 years prior to the first dose. 12. History of major medical conditions within 1 year prior to the first dose.
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Get notified about this study
Sign up to get updates when this study changes or when new studies for Non-small cell lung cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Guangdong Provincial People's Hospital
Guangzhou, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Smaller chest drain may speed recovery after lung cancer surgery
- Gut bacteria may hold clues to why some cancer treatments work better
- Breath-Tracking sensor aims to sharpen lung cancer scans
- Can PET scan signals predict who beats lung cancer with immunotherapy?
- Two-Drug combo takes aim at Hard-to-Treat lung cancer