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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04151563




Registration number
NCT04151563
Ethics application status
Date submitted
1/11/2019
Date registered
5/11/2019
Date last updated
19/12/2023

Titles & IDs
Public title
A Clinical Study Evaluating Nivolumab-containing Treatments in Patients With Advanced Non-small Cell Lung Cancer After Failing Previous PD-1/(L)1 Therapy and Chemotherapy
Scientific title
A Phase 1/2, Randomized Study Evaluating Multiple Nivolumab Combination Therapies in Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC) After Failure of Platinum-Based Chemotherapy and Anti-PD-1 (L)1 Immunotherapy
Secondary ID [1] 0 0
2018-004283-65
Secondary ID [2] 0 0
CA209-79X
Universal Trial Number (UTN)
Trial acronym
CheckMate 79X
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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
Other interventions - nivolumab
Other interventions - ipilimumab
Treatment: Drugs - cabozantinib
Other interventions - docetaxel
Other interventions - ramucirumab
Treatment: Drugs - lucitanib

Experimental: Arm A: cabozantinib + nivolumab + ipilimumab -

Experimental: Arm B: cabozantinib + nivolumab -

Experimental: Arm C: nivolumab + ramucirumab + docetaxel -

Experimental: Arm D: lucitanib + nivolumab -

Experimental: Arm E: nivolumab + docetaxel -

Active Comparator: Arm F: docetaxel -


Other interventions: nivolumab
Specified dose on Specified days

Other interventions: ipilimumab
Specified dose on Specified days

Treatment: Drugs: cabozantinib
Specified dose on Specified days

Other interventions: docetaxel
Specified dose on Specified days

Other interventions: ramucirumab
Specified dose on Specified days

Treatment: Drugs: lucitanib
Specified dose on Specified days
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Reponse Rate (ORR) using RECIST 1.1 per Blinded Independent Central Review (BICR) assessment
Timepoint [1] 0 0
approximately 33 months
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to 5 Years
Secondary outcome [2] 0 0
Duration of Response (DOR) by BICR using RECIST 1.1
Timepoint [2] 0 0
approximately 33 months
Secondary outcome [3] 0 0
Progression-Free Survival (PFS) by BICR using RECIST 1.1
Timepoint [3] 0 0
Up to 5 Years
Secondary outcome [4] 0 0
Incidence of Adverse Events (AEs)
Timepoint [4] 0 0
Up to 5 Years
Secondary outcome [5] 0 0
Incidence of Serious Adverse Events (SAEs)
Timepoint [5] 0 0
Up to 5 Years
Secondary outcome [6] 0 0
Incidence of Select AEs
Timepoint [6] 0 0
Up to 5 Years

Eligibility
Key inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria

* Histologically or cytologically-documented Stage IV A/B non-small cell lung Cancer, stage IIIB/C disease failed concurrent chemoRT.
* ECOG Performance Status of = 1.
* Radiologically-documented disease progression on one anti-PD-1/anti-PD-L1 therapy and one platinum-based doublet regimen given either concurrently or sequentially within 90 days after the last dose of anti-PD-(L)1.
* All participants must have tumor tissue submitted prior to randomization, either a recent archival sample obtained on/after the date of disease progression of the last prior anticancer therapy and within 3 months prior to enrollment, or a fresh biopsy obtained during the screening period.
* Prior toxicities must have resolved to grade =1.
* Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test and must not be breastfeeding.
* Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception. In addition, male participants must be willing to refrain from sperm donation during this time and must agree to follow instructions for method(s) of contraception. Azoospermic males are exempt from contraceptive requirements as well as WOCBP who are continuously not heterosexually active, however, a pregnancy test will still be required.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

* Prior treatment with Docetaxel.
* Untreated CNS metastases, carcinomatous meningitis or leptomeningeal metastases.
* Any tumor invading the Superior Vena Cava other blood vessel, GI Tract or Trachea.
* EGFR mutations, ALK translocations, ROS1 translocations which are sensitive to inhibitor therapy.
* History of cerebrovascular accident and coagulation disorders.
* Participants with interstitial lung disease, history of cerebrovascular accident or history of abdominal fistula, gastrointestinal perforation, bowel obstruction, intra-abdominal abscess or grade 3-4 bleeding event within 6 months prior to randomization.
* Known toxicity on prior checkpoint inhibitor treatment.
* Participants who received more than one line of anti- PD-1/PD-L1 treatment.
* Participants who received previous CTLA-4 inhibitor treatment.
* Participants with known BRAF V600E mutation which are sensitive to available targeted inhibitor therapy are excluded.
* Other protocol-defined Inclusion/Exclusion criteria apply.

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 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
15/04/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
13/05/2026
Actual
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Michigan
Country [2] 0 0
Argentina
State/province [2] 0 0
Buenos Aires
Country [3] 0 0
Argentina
State/province [3] 0 0
Distrito Federal
Country [4] 0 0
Belgium
State/province [4] 0 0
Charleroi
Country [5] 0 0
Belgium
State/province [5] 0 0
Gilly
Country [6] 0 0
Belgium
State/province [6] 0 0
Leuven
Country [7] 0 0
Denmark
State/province [7] 0 0
Copenhagen Ø
Country [8] 0 0
Greece
State/province [8] 0 0
Athens
Country [9] 0 0
Greece
State/province [9] 0 0
Neo Faliro
Country [10] 0 0
Mexico
State/province [10] 0 0
Coahuila
Country [11] 0 0
Mexico
State/province [11] 0 0
Distrito Federal
Country [12] 0 0
Mexico
State/province [12] 0 0
Jalisco
Country [13] 0 0
Mexico
State/province [13] 0 0
Puebla
Country [14] 0 0
Netherlands
State/province [14] 0 0
Amsterdam
Country [15] 0 0
Netherlands
State/province [15] 0 0
Rotterdam
Country [16] 0 0
Norway
State/province [16] 0 0
Oslo
Country [17] 0 0
Poland
State/province [17] 0 0
Mazowieckie
Country [18] 0 0
Poland
State/province [18] 0 0
Krakow
Country [19] 0 0
Romania
State/province [19] 0 0
Craiova
Country [20] 0 0
Romania
State/province [20] 0 0
Timisoara

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study is for participants with Non-small Cell Lung Cancer that has spread or has reoccurred after failure of Chemotherapy and Immunotherapy
Trial website
https://clinicaltrials.gov/study/NCT04151563
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
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/NCT04151563