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New combo aims to stall lung cancer when targeted pills start to fail
NCT ID NCT07669051
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase II trial tests whether adding ivonescimab (an immunotherapy drug) to the current targeted therapy pill can help people with advanced non-small cell lung cancer whose disease is slowly progressing. The study involves 36 adults with a specific EGFR gene mutation. Researchers will measure how long the cancer stays under control and any side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ivonescimab (a drug that helps the immune system fight cancer) combined with an EGFR-TKI (a targeted cancer pill)
- What this could lead to
- If successful, this combination could offer a new treatment option for people with advanced lung cancer whose disease is slowly getting worse on current targeted therapy.
- What could go wrong
- This is a small, early-phase trial with only 36 participants, so results may not apply to everyone. The combination may cause side effects or not work better than existing options.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 36 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jan 2026
- Expected to finish
-
Jan 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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\. Voluntarily signed written informed consent form; 2. Age ≥ 18 years; 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 4. Expected survival ≥ 3 months; 5. Histologically or cytologically confirmed locally advanced (stage IIIB/IIIC) or metastatic (stage IV) non-squamous non-small cell lung cancer (NSCLC), which is unresectable for complete surgical resection and not eligible for radical concurrent/sequential chemoradiotherapy, staged per the 8th edition TNM Staging for Lung Cancer released by the Union for International Cancer Control (UICC) and American Joint Committee on Cancer (AJCC); 6. Positive EGFR sensitive activating mutation confirmed by tumor histology, cytology or hematology testing before enrollment, including exon 19 deletion (19Del) and exon 21 point mutation (L858R); patients with EGFR T790M mutation are also eligible for enrollment; 7. Developed slow progression or potential progression during EGFR-TKI therapy: 8. Presence of at least one measurable lesion; 9. Normal function of major organs, meeting all the following criteria: Routine blood test results meet the requirements (no blood transfusion, no use of hematopoietic growth factors, no drug correction within 14 days before testing): a. Absolute neutrophil count (ANC) ≥ 1.5×10⁹/L (1,500/mm³); b. Platelet count (PLT) ≥ 90×10⁹/L (90,000/mm³); c. Hemoglobin (HB) ≥ 90 g/L; 10. Biochemical test results meet the following criteria: 1. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN; 2. Serum albumin (ALB) ≥ 28 g/L; 3. Serum creatinine (sCr) ≤ 1.5×ULN; urine protein \< 2+ or 24-hour urinary total protein quantification \< 1.0 g (creatinine clearance calculated per Cockcroft-Gault formula); Coagulation function meets the requirements: International Normalized Ratio (INR) ≤ 1.5×ULN and activated partial thromboplastin time (APTT) ≤ 1.5×ULN; Exclusion Criteria: \-
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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
-
Shandong cancer hospital and institute
Jinan, Shandong, 250000, China
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