AK112 Neoadjuvant/Adjuvant Treatment for Resectable NSCLC

Resectable Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05247684
• Other study ID #: AK112-205
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: February 20, 2022
• Est. completion date: January 20, 2025

Study information

• Verified date: February 2022
• Source: Akeso
• Contact: Weifeng Song, MD
• Phone: 86(0760)89873999
• Email: clinicaltrials[@]akesobio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: January 20, 2025
• Est. primary completion date: August 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Resectable Non-small Cell Lung Cancer

Intervention

Drug:
• AK112
IV infusion
• Carboplatin
IV infusion
• Cisplatin
IV infusion
• Paclitaxel
IV infusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Akeso

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of adverse events (AE)	Summary of AE incidence; summary after grading of AE according to NCI CTCAE version 5.0	Up to approximately 2 years
Primary	rate of surgical delays	Proportion of subjects exceeding the maximum surgical time window	Up to approximately 2 years
Primary	abnormal laboratory findings of clinical significance	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.	Up to approximately 2 years
Primary	MPR	Proportion of subjects with =10% residual live tumor cells in resected primary tumor foci and lymph nodes	Up to approximately 2 years
Secondary	R0 resection rate	Proportion of subjects with pathologically complete resection of primary tumors	Up to approximately 2 years
Secondary	Tumor descending stage rate	Proportion of subjects with the most recent tumor staging prior to surgery (using TNM staging version 8) who were down-staged relative to baseline	Up to approximately 2 years
Secondary	pCR	Proportion of subjects with no residual tumor in the resected tumor primary and lymph nodes	Up to approximately 2 years
Secondary	OS	Time from first dose until death from any cause	Up to approximately 2 years
Secondary	EFS	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.	Up to approximately 2 years
Secondary	ORR	ORR is the proportion of subjects with CR or PR,based on recist v1.1	Up to approximately 2 years