A Phase II Trial of AK112 (PD1/VEGF Bispecific) in Combination With Chemotherapy in Patients With NSCLC

Who is this study for? Patients with stage IIIB/C or IV non-small cell lung cancer
What treatments are being studied? AK112
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a phase II study. All patients are stage IIIB/C or IV non-small cell lung cancer(NSCLC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1. The purpose of this study is to evaluate the efficacy and safety of AK112 in combination with chemotherapy in patients with NSCLC.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 18 to 75 years old (at the time of inform consent obtained).

• Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures).

• Have histologically- or cytologically-confirmed diagnosis of Stage IIIB/C or IV NSCLC.

• Be able to provide formalin fixed, paraffin-embedded (FFPE) tumor tissue obtained from either a core or excisional tumor biopsy.

• Have a life expectancy of at least 3 months.

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

• Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator

• Has adequate organ function

• 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.

Locations
Other Locations
China
Sun Yat-Sen University Cancer Center
RECRUITING
Guanzhou
Contact Information
Primary
Weifeng Song, MD
clinicaltrials@akesobio.com
+86(0760)89873999
Time Frame
Start Date: 2021-02-01
Estimated Completion Date: 2025-03
Participants
Target number of participants: 296
Treatments
Experimental: Part1 Cohort1(AK112 + Pemetrexed or Paclitaxel+Carboplatin)
non-Squamous NSCLC:Subjects receive AK112 plus Pemetrexed and Carboplatin on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK112 plus Pemetrexed until progression.~Squamous NSCLC:Subjects receive AK112 plus Paclitaxel and Carboplatin on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK112 until progression.
Experimental: Part1 Cohort2(AK112 + Pemetrexed +Carboplatin)
Subjects receive AK112 plus Pemetrexed and Carboplatin on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK112 plus Pemetrexed until progression.
Experimental: Part1 Cohort3(AK112 + Docetaxel)
Subjects receive AK112 plus Docetaxel on Day 1 of every 3-week cycle (Q3W) until progression.
Experimental: Part2 (AK112 + Pemetrexed or Paclitaxel+Carboplatin)
non-Squamous NSCLC:Subjects receive AK112 plus Pemetrexed and Carboplatin on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK112 plus Pemetrexed until progression.~Squamous NSCLC:Subjects receive AK112 plus Paclitaxel and Carboplatin on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK112 until progression.
Experimental: Part3 group A(AK112 + Docetaxel)
Subjects receive AK112 plus Docetaxel on Day 1 of every 3-week cycle (Q3W) until progression.
Experimental: Part3 group B(AK112)
Subjects receive AK112 on Day 1 of every 3-week cycle (Q3W) until progression.
Experimental: Part3 group C(Docetaxel)
Subjects receive Docetaxel on Day 1 of every 3-week cycle (Q3W) until progression.
Sponsors
Leads: Akeso

This content was sourced from clinicaltrials.gov

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