AK112 Neoadjuvant/Adjuvant Treatment for Resectable NSCLC

NCT ID: NCT05247684

Last Updated: 2022-02-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-20
• Study Completion Date: 2025-01-20

Brief Summary

AK112, alone or in combination with chemotherapy for the neoadjuvant/adjuvant treatment of resectable NSCLC

Detailed Description

Phase II clinical study of AK112, an anti-PD-1 and VEGF bispecific antibody, alone or in combination with chemotherapy for the neoadjuvant/adjuvant treatment of resectable non-small cell lung cancer

Conditions

Resectable Non-small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

arm 1(AK112)

Neoadjuvant therapy was 3-4 cycles of AK112(Q3W), followed by surgery ,followed by adjuvant therapy for 16 cycles of AK112(Q3W)

Group Type: EXPERIMENTAL

AK112

Intervention Type: DRUG

IV infusion

arm 2(AK112+Carboplatin/cisplatin + paclitaxel)

Neoadjuvant therapy was 3-4 cycles of AK112 plus Carboplatin/cisplatin + paclitaxel(Q3W), followed by surgery ,followed by adjuvant therapy for 16 cycles of AK112(Q3W)

Group Type: EXPERIMENTAL

AK112

Intervention Type: DRUG

IV infusion

Carboplatin

Intervention Type: DRUG

IV infusion

Cisplatin

Intervention Type: DRUG

IV infusion

Paclitaxel

Intervention Type: DRUG

IV infusion

Interventions

AK112

IV infusion

Intervention Type: DRUG

Carboplatin

IV infusion

Intervention Type: DRUG

Cisplatin

IV infusion

Intervention Type: DRUG

Paclitaxel

IV infusion

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1、18 to 75 years old

2、Be able and willing to provide written informed consent and to comply with all requirements of study participation

3、Histologically confirmed resectable stage II-IIIB NSCLC

4、Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

5、Has adequate organ function

6、All female and male subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 120 days after the last dose of study treatment.

Exclusion Criteria

1. Is currently participating in a study of an investigational agent or using an investigational device

2. Has an active autoimmune disease that has required systemic treatment in the past 2 years

3. Has an active infection requiring systemic therapy

4. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected)

5. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study

6. Has received a live virus vaccine within 30 days prior to first dose of study treatment

7. Is pregnant, breastfeeding, or expecting to conceive or father a child within the projected duration of the study including 120 days following the last dose of study treatment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Akeso

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Weifeng Song, MD

Role: CONTACT

clinicaltrials@akesobio.com

86(0760)89873999

Changli Wang

Role: CONTACT

Other Identifiers

AK112-205

Identifier Type: -

Identifier Source: org_study_id