NCT05377658 AK104 With Chemotherapy as Neoadjuvant and Adjuvant Therapy for Resectable Non-small Cell Lung Cancer
| NCT ID | NCT05377658 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Henan Cancer Hospital |
| Condition | Non-small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 43 participants |
| Start Date | 2022-07-26 |
| Primary Completion | 2024-12-31 |
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 43 participants in total. It began in 2022-07-26 with a primary completion date of 2024-12-31.
⚠ 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
AK104, a tetravalent bispecific antibody targeting PD-1 and CTLA-4, is designed to retain the efficacy benefit of combination of PD-1 and CTLA-4 and improve on the safety profile of the combination therapy. The aim of this study is to evaluate the efficacy and safety of AK104 with chemotherapy as neoadjuvant and adjuvant therapy for patients with resectable stage II-IIIA NSCLC.
Eligibility Criteria
Key Inclusion Criteria: 1. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 2. Have previously untreated and pathologically confirmed resectable Stage II-IIIA NSCLC. 3. Have at least one measurable lesion per RECIST 1.1 assessed by investigator. 4. Have adequate organ function. Key Exclusion Criteria: 1. Mixed NSCLC and small cell lung cancer histology. 2. Patients with other active malignancies within 3 years prior to enrollment. 3. Known active autoimmune diseases. 4. Use of immunosuppressive agents within 14 days prior to the first dose of study treatment. 5. Presence of other uncontrolled serious medical conditions.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05377658 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Non-small Cell Lung Cancer. 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 NCT05377658 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 NCT05377658 currently recruiting?
Yes, NCT05377658 is actively recruiting participants. Contact the research team at 18638561588@163.com for enrollment information.
Where is the NCT05377658 trial being conducted?
This trial is being conducted at Zhengzhou, China.
Who is sponsoring the NCT05377658 clinical trial?
NCT05377658 is sponsored by Henan Cancer Hospital. The trial plans to enroll 43 participants.
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