New hope for lung cancer patients who stop responding to targeted drugs
NCT ID NCT05184712
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 3 trial tests whether adding the experimental drug AK112 (ivonescimab) to standard chemotherapy can help people with a certain type of advanced lung cancer (EGFR-mutant non-squamous NSCLC) whose cancer has worsened after targeted therapy. About 322 participants will receive either AK112 plus chemo or a placebo plus chemo. The main goal is to see if the combination delays cancer progression.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ivonescimab (AK112) combined with 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 has stopped responding to standard targeted therapy.
- What could go wrong
- This is a phase 3 trial, but results are not yet available. The drug combination may not improve survival or could cause significant side effects. It is only tested in a specific patient group.
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 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
322 people
The number who actually took part.
- Started
-
Jan 2022
- Expected to finish
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Sep 2026
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. Ability to understand and voluntarily sign a written informed consent form (ICF), which must be signed before the specified study procedures required for the study are performed. 2. Males or females aged ≥ 18 to ≤ 75 years at the time of signing informed consent. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1. 4. Life expectancy ≥3 months; 5. Locally advanced (stage IIIB/IIIC) or metastatic (stage IV) non-squamous NSCLC confirmed by histology or cytology, inoperable and unable to receive radiotherapy and chemotherapy; 6. The tumor histology, cytology or hematology confirmed the presence of EGFR activating mutations before enrollment 7. Have previously received EGFR-TKI treatment and the treatment has failed 8. Subjects have at least one measurable non-brain tumor lesion per RECIST v1.1 9. Major organ function prior to treatment meets the following criteria 10. Patients of childbearing potential must agree to use effective contraceptive measures Exclusion Criteria: 1. Histological or cytological pathology confirmed the presence of small cell carcinoma components, or the main component is squamous cell carcinoma 2. There are reports confirming the existence of other driver gene mutations with known drug treatments 3. Subjects who received any prior treatments targeting the mechanism of tumor immunity 4. The subject has received systemic anti-tumor therapy other than EGFR-TKI 5. Currently enrolled in any other clinical study 6. Received EGFR-TKI treatment, palliative local treatment, non-specific immunomodulatory treatment within 2 weeks prior to the first dose; and Chinese herbal medicine or traditional Chinese medicinal products with anti-tumor indications within 1 weeks prior to the first dose. 7. Tumor surrounds important blood vessels or has obvious necrosis, cavitation, or invades surrounding important organs and blood vessels. 8. Symptomatic central nervous system metastases 9. Active malignancies within the past 3 years, with the exception of tumors in this study and cured local tumors 10. Active autoimmune disease requiring systemic treatment within 2 years prior to the start of study treatment 11. There is a history of major diseases 1 year prior to the first dose. 12. .Medical history of gastrointestinal perforation or gastrointestinal fistula within 6 months prior to the first dose 13. Received chest radiation therapy prior to the first dose 14. Presence of clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring frequent drainage. 15. Active or previously documented inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis).
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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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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510000, China
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Other studies related to the condition(s) this trial covers.
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