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

Efficacy Clinical Trial

— Apple  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06196814
• Other study ID #: HCH20231225
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: April 1, 2024
• Est. completion date: February 1, 2027

Study information

• Verified date: March 2024
• Source: Hunan Province Tumor Hospital
• Contact: Yongchang Zhang
• Phone: +8613873123436
• Email: zhangyongchang[@]csu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: February 1, 2027
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Eligible subjects selected for this study must meet all of the following criteria:

1. Sign written informed consent before implementing any trial-related procedures;

2. Age =18 years old and =75 years old;

3. No limit on the gender;

4. The ECOG score is 0 or 1.

• 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.

Exclusion Criteria:

• Histological or cytological pathology confirmed the presence of a small cell carcinoma component, or a squamous cell carcinoma as a major component
• Patients who have received immunotherapy previously, including immune checkpoint inhibitors (such as anti-PD-1/L1, anti-CTLA-4 , anti-LAG-3, etc.), immune checkpoint activators (such as ICOS, CD40, CD137, GITR, OX40 antibodies, etc.), immune cell therapy and any other treatment targeting the immunity mechanism.
• Previously received other anti-tumor therapy for advanced stages of NSCLC (stages IIIB to IV) (including cytotoxic chemotherapy used with radiotherapy, systemic chemotherapy, and anti-VEGFR therapy) . Patients who have previously undergone adjuvant/neoadjuvant chemotherapy with the aim of curing non-metastatic diseases are eligible for inclusion in this study if disease progression occurs at least 6 months after the completion of the last chemotherapy cycle.
• Concurrent enrollment in another clinical trial is allowed, unless it involves a non-interventional clinical study or the follow-up period of an interventional study (defined as the time elapsed from the initiation of the first drug to at least 4 weeks after the last drug administration in the previous clinical study or beyond 5 half-lives of the investigational drug in that study, whichever is shorter).
• Received TKI treatment within the 2 weeks preceding the first dose; underwent palliative local therapy for non-target lesions within the 2 weeks preceding the first dose; received non-specific immunomodulatory therapy within the 2 weeks preceding the first dose, such as interleukins, interferons, thymosin alpha-1, tumor necrosis factor, etc. (excluding IL-11 used for treating thrombocytopenia); received herbal medicine or traditional Chinese medicine with anti-tumor indications within the 1 week preceding the first dose.

Related Conditions & MeSH terms

• Efficacy

Intervention

Drug:
• PD-1/VEGR bispecific antibodies (AK112) plus Platinum-based Chemotherapy
PD-1/VEGR bispecific antibodies (AK112) plus Platinum-based Chemotherapy.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hunan Province Tumor Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RP2D	We want to evaluate the best dose for treatment.	2 months
Primary	ORR	Overall response rate	12 months
Primary	PFS	Progression free survival time	12 months