AK104 With Chemotherapy as Neoadjuvant and Adjuvant Therapy for Resectable Non-small Cell Lung Cancer

Phase 2

Recruiting

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: AK104; Drug: Albumin-Bound Paclitaxel; Drug: Carboplatin

• Registration Number: NCT05377658
• Lead Sponsor: Henan Cancer Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-10
• Study First Submitted QC: 2022-05-16
• Study First Posted: 2022-05-17
• Study Start: 2022-07-26
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-19
• Last Update Posted: 2024-02-21
• Primary Completion: 2024-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 43

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AK104+albumin-bound paclitaxel+carboplatin	Albumin-Bound Paclitaxel	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+albumin-bound paclitaxel+carboplatin	AK104	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+albumin-bound paclitaxel+carboplatin	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.

Primary Outcome Measures

Name	Time	Method
Pathological Complete Response (pCR) Rate	At time of surgery	defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy.

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	At the end of 3 cycles of neoadjuvant therapy (each cycle is 21 days)	defined as the percentage of participants having complete response or partial response to protocol treatment. Objective response will be measured by RECIST 1.1.
Event Free Survival (EFS)	Up to approximately 5 years	defined as the time from the first dose of study drug to disease progression per RECIST 1.1 that precludes surgery, local or distant recurrence, or death due to any cause, whichever occurs first.
Major Pathological Response (MPR) Rate	At time of surgery	defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy.
Incidence of Surgical Complications	Up to approximately 30 days following surgery	defined as ≥ grade 3 or severe intraoperative and perioperative complications.
Complete (R0) Resection Rate	After surgery (approximately 7 weeks)	defined as the percentage of participants achieving complete surgical resection following completion of neoadjuvant therapy.
Adverse Events (AEs)	From the first dose of neoadjuvant treatment until 90 days after the last dose of adjuvant treatment

Trial Locations

Locations (1)

Henan Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China