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

NCT06196814 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: HCH20231225
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Efficacy

Outcome Measures

Primary Outcomes (3)

• RP2D

  We want to evaluate the best dose for treatment.

  2 months

• ORR

  Overall response rate

  12 months

• PFS

  Progression free survival time

  12 months

Study Arms (3)

Cohort of EGFR Sensitve Mutant NSCLC

EXPERIMENTAL

Efficay, Satety and Dose Escalation of AK112 plus Platinum-based Chemotherapy for EGFR Sensitive mutant NSCLC who Failed from First-Line Osimertinib.

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

Cohort of ALK Fusion NSCLC

EXPERIMENTAL

Efficay and Satety of PD-1/VEGR bispecific antibodies (AK112) plus Platinum-based Chemotherapy for ALK fusion NSCLC who Failed from First-Line Osimertinib.

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

Cohort of ROS1 Fusion NSCLC

EXPERIMENTAL

Efficay and Satety of PD-1/VEGR bispecific antibodies (AK112) plus Platinum-based Chemotherapy for ROS1 fusion NSCLC who Failed from First-Line Crizotinib.

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

Interventions

PD-1/VEGR bispecific antibodies (AK112) plus Platinum-based Chemotherapy DRUG

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

Cohort of ALK Fusion NSCLC; Cohort of EGFR Sensitve Mutant NSCLC; Cohort of ROS1 Fusion NSCLC

Eligibility Criteria

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

You may qualify if:

• Eligible subjects selected for this study must meet all of the following criteria:
• Sign written informed consent before implementing any trial-related procedures;
• Age ≥18 years old and ≤75 years old;
• No limit on the gender;
• 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.

You may not qualify if:

• 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) .
• 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.

Sponsors & Collaborators

• Hunan Province Tumor Hospital: lead

Central Study Contacts

Yongchang Zhang

CONTACT

+8613873123436; zhangyongchang@csu.edu.cn

Liang Zeng

CONTACT

15974139200; 530490930@qq.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Model Details: 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. We will colect the satety and efficacy data for all the patients.

Study Record Dates

• First Submitted: December 25, 2023
• First Posted: January 9, 2024
• Study Start: October 1, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share