NCT06769295 A Phase II Study of AK112 (PD1/VEGF Bispecific) in Combination with Chemotherapy in Patients with NSCLC
| NCT ID | NCT06769295 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Sichuan University |
| Condition | Lung Cancer, Non-Small Cell |
| Study Type | INTERVENTIONAL |
| Enrollment | 28 participants |
| Start Date | 2025-02-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 28 participants in total. It began in 2025-02-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a phase II study. All patients are stage IV non-squamas non-small cell lung cancer(NSCLC) with malignant pleura effusion, Eastern Cooperative Oncology Group (ECOG) performance status 0-2. The purpose of this study is to evaluate the efficacy and safety of AK112 in combination with chemotherapy in patients with NSCLC with malignant pleura effusion.
Eligibility Criteria
Inclusion Criteria: * 18 to 75 years old (at the time of inform consent obtained)； * Have histologically- or cytologically-confirmed diagnosis of Stage IV non-squamas NSCLC； * The presence of malignant pleural effusion (positive pleural effusion cytology or multiple pleural nodules or thickening with pleural effusion on CT imaging)； * Driver gene mutation negative； * Have a life expectancy of at least 3 months； * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2； * Has adequate organ function； * Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator； * Be able to provide formalin fixed, paraffin-embedded (FFPE) tumor tissue obtained from either a core or excisional tumor biopsy； * All female and male subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 120 days after the last dose of study treatment； * Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures). Exclusion Criteria: * Histological or cytological pathology confirmed the presence of small cell carcinoma components, or the main component is squamous cell carcinoma； * Active malignancies within the past 3 years, with the exception of tumors in this study and cured local tumors； * Is currently participating in a study of an investigational agent or using an investigational device; * Active autoimmune disease requiring systemic treatment within 2 years prior to the start of study treatment； * Subjects who received any prior treatments targeting VEGFR; * Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected); * History of myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or surgery within 12 months prior to day 1 of study treatment; * Has undergone major surgery within 30 days prior to the first dose of study treatment; * Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment NOTE: Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; * Has received a live virus vaccine within 30 days prior to first dose of study treatment；
Contact & Investigator
Yongsheng Wang, Prof
PRINCIPAL INVESTIGATOR
West China Hospital
Frequently Asked Questions
Who can join the NCT06769295 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Lung Cancer, Non-Small Cell. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06769295 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06769295 currently recruiting?
Yes, NCT06769295 is actively recruiting participants. Contact the research team at gg1023@foxmail.com for enrollment information.
Where is the NCT06769295 trial being conducted?
This trial is being conducted at Chengdu, China.
Who is sponsoring the NCT06769295 clinical trial?
NCT06769295 is sponsored by Sichuan University. The principal investigator is Yongsheng Wang, Prof at West China Hospital. The trial plans to enroll 28 participants.
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