To hear about similar clinical trials, please enter your email below
Trial Title:
AK112 in Combination With Chemotherapy in Advanced Squamous Non-Small Cell Lung Cancer
NCT ID:
NCT05840016
Condition:
Advanced Squamous Non Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Carboplatin
Tislelizumab
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
AK112, Carboplatin, Paxlitaxel
Description:
IV infusion,Specified dose on specified days
Arm group label:
Experimental: AK112 in Combination With Paclitaxel Plus Carboplatin
Intervention type:
Drug
Intervention name:
Tislelizumab, Carboplatin, Paxlitaxel
Description:
IV infusion,Specified dose on specified days
Arm group label:
Active Comparator: Tislelizumab in Combination With Paclitaxel Plus Carboplatin
Summary:
This trial is a Phase III study. All patients are stage IIIB/C (unsuitable for radical
therapy) or stage IV squamous 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 combined with chemotherapy versus Tislelizumab combined
with chemotherapy in patients with advanced squamous NSCLC.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Be able and willing to provide written informed consent and to comply with all
requirements of study participation (including all study procedures).
- ≥18 years old(at the time consent is obtained).
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Has a life expectancy of at least 3 months.
- Has a histologically or cytologically confirmed diagnosis of squamous NSCLC.
- Has Stage IIIB/C or IV NSCLC (American Joint Committee on Cancer [AJCC]).
- Has no prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC.
- Has measurable disease based on Response Evaluation Criteria in Solid Tumors
(RECIST) 1.1.
- Has adequate organ function.
Exclusion Criteria:
- Histological diagnosis of non-squamous NSCLC.
- Has EGFR-sensitive mutations or ALK gene translocations.
- Known ROS1 rearrangement, MET exon 14 skipping mutation, or RET gene fusion
positivite.
- Is currently participating in a study of an investigational agent or using an
investigational device.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy within
2 years prior to the first dose of study treatment.
- Has undergone major surgery within 30 days of Study Day 1.
- Has known active central nervous system (CNS) metastases.
- Has an active autoimmune disease that has required systemic treatment in the past 2
years (i.e. with use of disease modifying agents, corticosteroids or
immunosuppressive drugs).
- Has an active infection requiring systemic therapy.
- Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA
[qualitative] is detected).
- History of myocardial infarction, unstable angina, congestive heart failure within
12 months prior to day 1 of study treatment.
- Has known psychiatric or substance abuse disorders that would interfere with
cooperation with the requirements of the study.
- Has received a live virus vaccine within 30 days of the planned first dose of study
therapy.
- Has any concurrent medical condition that, in the opinion of the Investigator, would
complicate or compromise compliance with the study or the well-being of the subject.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Chest Hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Shun Lu, MD
Start date:
August 17, 2023
Completion date:
December 20, 2025
Lead sponsor:
Agency:
Akeso
Agency class:
Industry
Source:
Akeso
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05840016
