NCT06196814

AK112 Plus Platinum-based Chemotherapy for EGFR/ALK/ROS1 Positve NSCLC

Efficay and Satety of PD-1/VEGR Bispecific Antibodies (AK112) Plus Platinum-based Chemotherapy for EGFR/ALK/ROS1 Positve NSCLC: A Multiple Centers, Multiple Cohorts, Dose Escalation Phase II Apple Study

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Hunan Province Tumor Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The investigators want to evaluated the Efficay and Satety of PD-1/VEGR bispecific antibodies (AK112) plus Platinum-based Chemotherapy for EGFR/ALK/ROS1 Positve NSCLC who Failed from First-Line Standard Treatment.

Detailed description

The investigators want to evaluated the Efficay and Satety of PD-1/VEGR bispecific antibodies (AK112) plus Platinum-based Chemotherapy for EGFR/ALK/ROS1 Positve NSCLC who Failed from First-Line Standard Treatment. This study will be devided into three cohorts. Cohort A for EGFR mutation NSCLC, Patient with NGS idenfied EGFR sensitive mutation NSCLC who failed from first line Osimertinib will be included. The 3+3 stud will conducted for dose escalation for AK112 （from 20mg to 30mg), and than the fix dose will be set up for cohort A, B and C. Cohort B for ALK fusion NSCLC, Patient with NGS idenfied ALK fusion NSCLC who failed from first line Alectinib will be included. All the patients will be devided two group,3'ALK and 3'ALK with reteintion of 5'ALK. All the patients will be treated with PD-1/VEGR bispecific antibodies (AK112) plus Platinum-based Chemotherapy. Cohort C for ROS1 fusion NSCLC, Patient with NGS idenfied ROS1 fusion NSCLC who failed from first line crizotinib or Entrectinib will be included. All the patients will be treated with PD-1/VEGR bispecific antibodies (AK112) plus Platinum-based Chemotherapy. The investigators will collect the satety and efficacy data for all the patients.

Conditions

• Efficacy

Interventions

Type	Name	Description
DRUG	PD-1/VEGR bispecific antibodies (AK112) plus Platinum-based Chemotherapy	PD-1/VEGR bispecific antibodies (AK112) plus Platinum-based Chemotherapy.

Timeline

• Start date: 2024-10-01
• Primary completion: 2026-03-01
• Completion: 2027-02-01
• First posted: 2024-01-09
• Last updated: 2024-10-09