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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04786964




Registration number
NCT04786964
Ethics application status
Date submitted
4/03/2021
Date registered
8/03/2021
Date last updated
20/08/2024

Titles & IDs
Public title
Study of Pemetrexed+Platinum Chemotherapy With or Without Cosibelimab (CK-301) in First Line Metastatic Non-squamous Non-Small Cell Lung Cancer
Scientific title
A Randomized, Open-Label, Phase 3 Study of Cosibelimab (CK-301) in Combination With Platinum+Pemetrexed Chemotherapy in Subjects With First-Line Metastatic Non-squamous Non-Small Cell Lung Cancer
Secondary ID [1] 0 0
CK-301-301
Universal Trial Number (UTN)
Trial acronym
CONTERNO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Non-squamous Non Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cosibelimab
Treatment: Drugs - Cisplatin
Treatment: Drugs - Carboplatin
Treatment: Drugs - Pemetrexed
Treatment: Other - Folic acid 350-1000 µg
Treatment: Other - Vitamin B12 1000 µg
Treatment: Drugs - Dexamethasone 4mg

Experimental: Cosibelimab - Participants receive cosibelimab 1200 mg intravenously (IV) PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin Area Under the Curve (AUC) 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by cosibelimab 1200 mg IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression.

Active comparator: Control - Participants receive pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pemetrexed 500 mg/m\^2 IV Q3W until progression.


Treatment: Drugs: Cosibelimab
IV infusion

Treatment: Drugs: Cisplatin
IV infusion

Treatment: Drugs: Carboplatin
IV infusion

Treatment: Drugs: Pemetrexed
IV infusion

Treatment: Other: Folic acid 350-1000 µg
Orally; at least 5 doses of folic acid must be taken during the 7 days preceding the first dose of pemetrexed, and folic acid dosing must continue during the full course of therapy and for 21 days after the last dose of pemetrexed.

Treatment: Other: Vitamin B12 1000 µg
Intramuscular injection in the week preceding the first dose of pemetrexed and once every 3 cycles thereafter. Subsequent vitamin B12 injections may be given the same day as pemetrexed administration.

Treatment: Drugs: Dexamethasone 4mg
For prophylaxis; orally twice per day (or equivalent). Taken the day before, day of, and day after pemetrexed administration.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Approximately 3 years.
Secondary outcome [1] 0 0
Progression-Free Survival (PFS)
Timepoint [1] 0 0
Approximately 3 years.
Secondary outcome [2] 0 0
Objective response rate (ORR)
Timepoint [2] 0 0
Approximately 3 years.
Secondary outcome [3] 0 0
Duration of response (DOR)
Timepoint [3] 0 0
Approximately 3 years.
Secondary outcome [4] 0 0
Number of Participants Who Experienced an Adverse Event (AE)
Timepoint [4] 0 0
Approximately 3 years.

Eligibility
Key inclusion criteria
* Has a histologically-confirmed or cytologically confirmed diagnosis of stage IV non-squamous NSCLC.
* Has confirmation that epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK)-directed therapy is not indicated.
* Has measurable disease.
* Has not received prior systemic treatment for their advanced/metastatic NSCLC.
* Can provide tumor tissue.
* Has a life expectancy of at least 3 months.
* Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
* Has adequate organ function
* If female of childbearing potential, is willing to use adequate contraception for the course of the study through 120 days after the last dose of study medication or through 180 days after last dose of chemotherapeutic agents.
* If male with a female partner(s) of child-bearing potential, must agree to use adequate contraception starting with the first dose of study medication through 180 days after the last dose of study medication and chemotherapeutic agents.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has predominantly squamous cell histology NSCLC.
* Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to administration of study medication.
* Before the first dose of study medication: a) Has received prior systemic cytotoxic chemotherapy for metastatic disease, b) Has received antineoplastic biological therapy (e.g., erlotinib, crizotinib, cetuximab), c) Had major surgery (<3 weeks prior to first dose).
* Received radiation therapy to the lung that is >30 Gray (Gy) within 6 months of the first dose of study medication.
* Completed palliative radiotherapy within 7 days of the first dose of study medication.
* Is expected to require any other form of antineoplastic therapy while on study.
* Received a live-virus vaccination within 30 days of planned start of study medication.
* Has clinically active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, peritoneal carcinomatosis.
* Known history of prior malignancy except if participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy, except for successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ cancers.
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Previously had a severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb).
* Known sensitivity to any component of cisplatin, carboplatin or pemetrexed.
* Has active autoimmune disease that has required systemic treatment in past 2 years.
* Is on chronic systemic steroids.
* Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose =1.3 g per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).
* Is unable or unwilling to take folic acid or vitamin B12 supplementation.
* Had prior treatment with any other anti-programmed cell death-1 (PD-1), or PD-ligand 1 (PD-L1) or PD-L2 agent or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
* Has an active infection requiring therapy.
* Has known history of Human Immunodeficiency Virus (HIV).
* Has known active Hepatitis B or C.
* Has known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial.
* Is a known regular user of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol).
* Has symptomatic ascites or pleural effusion.
* Has active or history of interstitial lung disease or a history of (non infectious) pneumonitis that required steroids or current pneumonitis.
* Has had an allogeneic tissue/solid organ transplant.
* Any known uncontrolled or significant cardiovascular disease.
* Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/12/2023
Sample size
Target
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
Vitória
Country [2] 0 0
Georgia
State/province [2] 0 0
Tbilisi
Country [3] 0 0
Malaysia
State/province [3] 0 0
Kota Bharu
Country [4] 0 0
New Zealand
State/province [4] 0 0
Wellington
Country [5] 0 0
Peru
State/province [5] 0 0
Lima
Country [6] 0 0
Russian Federation
State/province [6] 0 0
Arkhangel'sk
Country [7] 0 0
Russian Federation
State/province [7] 0 0
Chelyabinsk
Country [8] 0 0
Russian Federation
State/province [8] 0 0
Kaliningrad
Country [9] 0 0
Russian Federation
State/province [9] 0 0
Kazan
Country [10] 0 0
Russian Federation
State/province [10] 0 0
Kursk
Country [11] 0 0
Russian Federation
State/province [11] 0 0
Kuzmolovskiy
Country [12] 0 0
Russian Federation
State/province [12] 0 0
Moscow
Country [13] 0 0
Russian Federation
State/province [13] 0 0
Nizhny Novgorod
Country [14] 0 0
Russian Federation
State/province [14] 0 0
Novosibirsk
Country [15] 0 0
Russian Federation
State/province [15] 0 0
Omsk
Country [16] 0 0
Russian Federation
State/province [16] 0 0
Saint Petersburg
Country [17] 0 0
Russian Federation
State/province [17] 0 0
Samara
Country [18] 0 0
Russian Federation
State/province [18] 0 0
Sochi
Country [19] 0 0
Russian Federation
State/province [19] 0 0
Tomsk
Country [20] 0 0
Russian Federation
State/province [20] 0 0
Volgograd
Country [21] 0 0
South Africa
State/province [21] 0 0
Pretoria
Country [22] 0 0
Thailand
State/province [22] 0 0
Chiang Mai

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Checkpoint Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is an efficacy and safety study of cosibelimab (CK-301) combined with pemetrexed/platinum chemotherapy versus pemetrexed/platinum chemotherapy alone in participants with advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have not previously received systemic therapy for advanced disease. Participants will be randomly assigned in a 2:1 ratio to receive cosibelimab combined with pemetrexed/platinum (Investigators choice of cisplatin or carboplatin), OR pemetrexed/platinum (Investigators choice of cisplatin or carboplatin).

The primary hypothesis is that cosibelimab in combination with pemetrexed/platinum chemotherapy prolongs Overall Survival (OS) compared to pemetrexed/platinum chemotherapy alone.
Trial website
https://clinicaltrials.gov/study/NCT04786964
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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/NCT04786964