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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05505825




Registration number
NCT05505825
Ethics application status
Date submitted
16/08/2022
Date registered
18/08/2022
Date last updated
24/05/2024

Titles & IDs
Public title
A Study of AK104 in Combination With Chiauranib in Patients With Extensive Stage Small Cell Lung Cancer
Scientific title
A Phase Ib/II Clinical Study of Anti-PD-1 and CTLA-4 Bispecific Antibody, Cadonilimab(AK104), in Combination With Chiauranib in the Treatment of Patients With Extensive Stage Small Cell Lung Cancer Who Failed First-line Platinum-based Chemotherapy in Combination With Programmed Cell Death-1(PD1)/Programmed Cell Death Protein Ligand-1(PDL1) Inhibitors
Secondary ID [1] 0 0
AK104-212
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
SCLC,Extensive Stage 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AK104 IV infusion;Chiauranib oral

Experimental: AK104 once every 3 weeks and Chiauranib once a day - Subjects receive AK104 once every 3 weeks plus Chiauranib once a day until intolerable toxicity, no more clinical benefit as judged by the investigator, or completion of 24 months of treatment, or meeting other criteria for termination of treatment in the protocol, whichever occurs first.


Treatment: Drugs: AK104 IV infusion;Chiauranib oral
AK104 IV infusion once every 3 weeks;Chiauranib once a day oral
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective response rate (ORR)
Timepoint [1] 0 0
Up to approximately 2 years
Primary outcome [2] 0 0
Incidence and severity of adverse events(AEs)
Timepoint [2] 0 0
Up to approximately 2 years
Secondary outcome [1] 0 0
Disease control rate (DCR)
Timepoint [1] 0 0
Up to approximately 2 years
Secondary outcome [2] 0 0
duration of response (DoR)
Timepoint [2] 0 0
Up to approximately 2 years
Secondary outcome [3] 0 0
time to response (TTR)
Timepoint [3] 0 0
Up to approximately 2 years
Secondary outcome [4] 0 0
progression-free survival (PFS)
Timepoint [4] 0 0
Up to approximately 2 years
Secondary outcome [5] 0 0
overall survival (OS)
Timepoint [5] 0 0
Up to approximately 2 years
Secondary outcome [6] 0 0
Pharmacokinetics(PK) profiles
Timepoint [6] 0 0
Up to approximately 2 years
Secondary outcome [7] 0 0
Immunogenicity assessment
Timepoint [7] 0 0
Up to approximately 2 years

Eligibility
Key inclusion criteria
1. The subject must sign the written informed consent form (ICF) voluntarily.
2. Aged = 18 to = 75 years.
3. Eastern Cooperative Oncology Group(ECOG) performance status score of 0 or 1.
4. Life expectancy= 3 months.
5. Histologically or cytologically confirmed ES-SCLC according to the Veterans Administration Lung Study Group(VALG) stage.
6. Phase Ib and II: Subjects with ES-SCLC who have failed prior first-line platinum-based chemotherapy in combination with PD1/PDL1 inhibitors will be enrolled.
7. At least 1 measurable lesion per RECIST v1.1, which is applicable for repeated accurate measurement. Brain metastatic lesions are not considered target lesions.
8. Adequate organ function.
9. Women of childbearing potential must have a negative urine or serum pregnancy test
10. If a nonsterile male subject has sexual intercourse with a female partner of childbearing potential, he must use an effective method of contraception from the start of screening until Day 120 after the last dose; it should be discussed with the Investigator whether contraception should be discontinued after this time point.
11. Subjects must be willing and able to comply with the scheduled visits, treatment regimens, laboratory tests, and other requirements in the study.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Malignancies other than SCLC within 3 years prior to enrollment. However, subjects with other malignancies that have been cured are eligible.
2. Concurrent enrollment in another clinical study, unless it is an observational, non-interventional clinical study or a follow-up period of an interventional study.
3. Subjects whose imaging at screening shows that the tumor encircles important blood vessels or has significant necrosis and cavitation, and the subjects'participation is associated with a risk of hemorrhage.
4. Tumor invasion of surrounding vital organs and blood vessels.
5. Subjects who had active autoimmune disease that required systemic treatment in the past two years.
6. Subjects with prior history of non-infectious pneumonitis/interstitial lung disease requiring systemic glucocorticoid therapy or with non-infectious pneumonitis at present.
7. Presence of metastases to brainstem, meninges and spinal cord, or spinal cord compression.
8. Subjects with pleural effusion, pericardial effusion, or ascites that are clinically symptomatic or require drainage.
9. Subjects with unresolved toxicity due to prior anti-tumor therapy, defined as failure to recover to National Cancer Institute Common Terminology Criteria for Adverse Events(NCI CTCAE) v5.0 Grade 0 or 1 (except for alopecia) or to the levels specified in the inclusion/exclusion criteria.
10. Subjects who cannot swallow pills, and who have malabsorption syndrome, or any condition affecting gastrointestinal absorption. Subjects with active or prior history of definite inflammatory bowel disease.
11. Subjects with a history of immunodeficiency; a positive human immunodeficiency virus (HIV) antibody test; and current long-term use of systemic corticosteroids or other immunosuppressants.
12. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
13. Subjects who had major surgical procedure or serious trauma within 30 days prior to the first dose, or a major scheduled surgery within 30 days after the first dose; subjects who had minor local surgery within 3 days prior to the first dose.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2025
Actual
Sample size
Target
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment hospital [2] 0 0
Icon Cancer Centre - South Brisbane
Recruitment hospital [3] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [4] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [5] 0 0
Peninsula & South Eastern Haematology and Oncology Group - Frankston
Recruitment hospital [6] 0 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 0 0
- Westmead
Recruitment postcode(s) [2] 0 0
- South Brisbane
Recruitment postcode(s) [3] 0 0
- Woolloongabba
Recruitment postcode(s) [4] 0 0
- Bedford Park
Recruitment postcode(s) [5] 0 0
- Frankston
Recruitment postcode(s) [6] 0 0
- St Albans
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Jilin

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Akeso
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Chipscreen Biosciences, Ltd.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
A Phase Ib/II open label,international multicentre study to evaluate the efficacy and safety of anti-PD-1 and CTLA-4 bispecific antibody AK104 in combination with Chiauranib in Patients with Extensive Stage Small Cell Lung Cancer Who Failed First-line Platinum-based Chemotherapy in Combination with PD1/PDL1 Inhibitors
Trial website
https://clinicaltrials.gov/study/NCT05505825
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ying Cheng, Professor
Address 0 0
Jilin Province Cancer Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05505825