AK112 Neoadjuvant/Adjuvant Treatment for Resectable NSCLC

Phase 2

Not yet recruiting

• Conditions: Resectable Non-small Cell Lung Cancer
• Interventions: Drug: AK112; Drug: Carboplatin; Drug: Cisplatin; Drug: Paclitaxel

• Registration Number: NCT05247684
• Lead Sponsor: Akeso

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

Study Timeline

• Study First Submitted: 2022-01-19
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-09
• Last Update Submitted: 2022-02-09
• Study Start: 2022-02-20
• Study First Posted: 2022-02-21
• Last Update Posted: 2022-02-21
• Primary Completion: 2023-08-20
• Study Completion: 2025-01-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
arm 2(AK112+Carboplatin/cisplatin + paclitaxel)	AK112	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)
arm 1(AK112)	AK112	Neoadjuvant therapy was 3-4 cycles of AK112(Q3W), followed by surgery ,followed by adjuvant therapy for 16 cycles of AK112(Q3W)
arm 2(AK112+Carboplatin/cisplatin + paclitaxel)	Carboplatin	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)
arm 2(AK112+Carboplatin/cisplatin + paclitaxel)	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)
arm 2(AK112+Carboplatin/cisplatin + paclitaxel)	Cisplatin	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)

Primary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events (AE)	Up to approximately 2 years	Summary of AE incidence; summary after grading of AE according to NCI CTCAE version 5.0
abnormal laboratory findings of clinical significance	Up to approximately 2 years	Proportion of subjects with abnormal and clinically significant results including routine blood tests, blood biochemical tests, coagulation tests, thyroid function tests, routine urine tests, pregnancy tests, etc.
MPR	Up to approximately 2 years	Proportion of subjects with ≤10% residual live tumor cells in resected primary tumor foci and lymph nodes
rate of surgical delays	Up to approximately 2 years	Proportion of subjects exceeding the maximum surgical time window

Secondary Outcome Measures

Name	Time	Method
ORR	Up to approximately 2 years	ORR is the proportion of subjects with CR or PR,based on recist v1.1
OS	Up to approximately 2 years	Time from first dose until death from any cause
pCR	Up to approximately 2 years	Proportion of subjects with no residual tumor in the resected tumor primary and lymph nodes
R0 resection rate	Up to approximately 2 years	Proportion of subjects with pathologically complete resection of primary tumors
Tumor descending stage rate	Up to approximately 2 years	Proportion of subjects with the most recent tumor staging prior to surgery (using TNM staging version 8) who were down-staged relative to baseline
EFS	Up to approximately 2 years	Time from first dose to the occurrence of any of the following events, whichever occurs first: disease progression, local recurrence or distant metastasis or death from any cause, as assessed according to RECIST v1.1.