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

NCT05377658 | Recruiting Phase 2

• 1 other identifier: AK104-IIT-005
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer

Keywords

neoadjuvant and adjuvant therapy; bispecific antibody

Outcome Measures

Primary Outcomes (1)

• Pathological Complete Response (pCR) Rate

  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.

  At time of surgery

Secondary Outcomes (6)

• Major Pathological Response (MPR) Rate

  At time of surgery

• Incidence of Surgical Complications

  Up to approximately 30 days following surgery

• Complete (R0) Resection Rate

  After surgery (approximately 7 weeks)

• Objective Response Rate (ORR)

  At the end of 3 cycles of neoadjuvant therapy (each cycle is 21 days)

• Event Free Survival (EFS)

  Up to approximately 5 years

Study Arms (1)

AK104+albumin-bound paclitaxel+carboplatin

EXPERIMENTAL

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.

Drug: AK104; Drug: Albumin-Bound Paclitaxel; Drug: Carboplatin

Interventions

AK104 DRUG

10 mg/kg via intravenous infusion on Day 1 of each 21-day cycle.

Also known as: Cadonilimab

AK104+albumin-bound paclitaxel+carboplatin

Albumin-Bound Paclitaxel DRUG

260mg/m\^2 via intravenous infusion on Day 1 of each 21-day cycle.

AK104+albumin-bound paclitaxel+carboplatin

Carboplatin DRUG

AUC 5 mg/mL/min via intravenous infusion on Day 1 of each 21-day cycle.

AK104+albumin-bound paclitaxel+carboplatin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• Have previously untreated and pathologically confirmed resectable Stage II-IIIA NSCLC.
• Have at least one measurable lesion per RECIST 1.1 assessed by investigator.
• Have adequate organ function.

You may not qualify if:

• Mixed NSCLC and small cell lung cancer histology.
• Patients with other active malignancies within 3 years prior to enrollment.
• Known active autoimmune diseases.
• Use of immunosuppressive agents within 14 days prior to the first dose of study treatment.
• Presence of other uncontrolled serious medical conditions.

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Albumin-Bound Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Coordination Complexes

Central Study Contacts

Huijuan Wang, MD

CONTACT

18638561588; 18638561588@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 17, 2022
• Study Start: July 26, 2022
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 21, 2024

Record last verified: 2024-02

Locations

CN (1)