AK104 With Chemotherapy as Neoadjuvant and Adjuvant Therapy for Resectable Non-small Cell Lung Cancer
NCT ID: NCT05377658
Last Updated: 2024-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
43 participants
INTERVENTIONAL
2022-07-26
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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AK104+albumin-bound paclitaxel+carboplatin
Participants receive 3 cycles of AK104 in combination with albumin-bound paclitaxel and carboplatin as neoadjuvant therapy prior to surgery; followed by surgery; followed by adjuvant AK104 for 9 cycles.
AK104
10 mg/kg via intravenous infusion on Day 1 of each 21-day cycle.
Albumin-Bound Paclitaxel
260mg/m\^2 via intravenous infusion on Day 1 of each 21-day cycle.
Carboplatin
AUC 5 mg/mL/min via intravenous infusion on Day 1 of each 21-day cycle.
Interventions
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AK104
10 mg/kg via intravenous infusion on Day 1 of each 21-day cycle.
Albumin-Bound Paclitaxel
260mg/m\^2 via intravenous infusion on Day 1 of each 21-day cycle.
Carboplatin
AUC 5 mg/mL/min via intravenous infusion on Day 1 of each 21-day cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
18 Years
75 Years
ALL
No
Sponsors
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Henan Cancer Hospital
OTHER_GOV
Responsible Party
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Huijuan Wang
chief physician
Locations
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Henan Cancer Hospital
Zhengzhou, Henan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AK104-IIT-005
Identifier Type: -
Identifier Source: org_study_id
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