AK112 Neoadjuvant/Adjuvant Treatment for Resectable NSCLC

Akeso

Status and phase: Active, not recruiting; Phase 2

Conditions: Resectable Non-small Cell Lung Cancer

Treatments: Drug: Paclitaxel; Drug: Cisplatin; Drug: AK112; Drug: Carboplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT05247684

AK112-205

Details and patient eligibility

About

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

Full 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

Enrollment: 90 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

arm 1(AK112)

Experimental group

Description:

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

Treatment:

Drug: AK112

arm 2(AK112+Carboplatin/cisplatin + paclitaxel)

Experimental group

Description:

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)

Treatment:

Drug: Carboplatin

Drug: AK112

Drug: Cisplatin

Drug: Paclitaxel