A Study of Nivolumab and Ipilimumab Combined with Chemotherapy Compared to Chemotherapy by Itself as the First Treatment Given for Stage IV Non-Small Cell Lung Cancer (NSCLC) (CheckMate 9LA)

• Register: EUCTR
• Last refreshed on: 28 August 2017
• Main ID: EUCTR2017-001195-35-ES
• Date of registration: 02/08/2017
• Prospective Registration: Yes
• Primary sponsor: Bristol-Myers Squibb International Corporation
• Public title: A Study of Nivolumab and Ipilimumab Combined with Chemotherapy Compared to Chemotherapy by Itself as the First Treatment Given for Stage IV Non-Small Cell Lung Cancer (NSCLC) (CheckMate 9LA)
• Scientific title: A Study of Nivolumab plus Ipilimumab in Combination with Chemotherapy vs Chemotherapy alone as First Line Therapy in Stage IV Non-Small Cell Lung Cancer (NSCLC) - CheckMate 9LA, CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 9LA
• Date of first enrolment: 17/08/2017
• Target sample size: 504
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-001195-35
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Belgium, Brazil, Canada, Chile, France, Germany, Ireland, Italy, Mexico, Poland, Romania, Russian Federation, Spain, United Kingdom, United States

Contacts

• Name: GCT-SU
• Affiliation: Bristol-Myers Squibb International Corporation

• Name: GCT-SU
• Affiliation: Bristol-Myers Squibb International Corporation

Key inclusion & exclusion criteria

Inclusion criteria:
- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test [minimum sensitivity 25 units per litre (IU/L) or equivalent units of human chorionic gonadotropin (HCG)] within 24 hours prior to the start of study drug

- WOCBP must agree to follow instructions for methods(s) of contraception for the duration of treatment with nivolumab and 5 months after the last dose of nivolumab (ie 30 days [duration of ovulatory cycle] plus the time required for nivolumab to undergo approximately five half-lives)

- Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with nivolumab and up to 7 months after the last dose of nivolumab (ie 90 days [duration of sperm turnover] plus the time required for nivolumab to undergo approximately five half-lives)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 328
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 176

Exclusion criteria:
- Participants with known epidermal growth factor receptor (EGFR) mutations which are sensitive to available targeted inhibitor therapy (including, but not limited to, deletions in exon 19 and exon 21 [L858R] substitution mutations) are excluded
- Participants with known anaplastic lymphoma kinase (ALK) translocations which are sensitive to available targeted inhibitor therapy are excluded
- Participants with untreated CNS metastases are excluded. Participants are eligible if CNS metastases are adequately treated and participants are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to first treatment

Other protocol inclusion/exclusion criteria may apply


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Stage IV Non-Small Cell Lung Cancer (NSCLC)
MedDRA version: 20.0 Level: PT Classification code 10029522 Term: Non-small cell lung cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Trade Name: Opdivo (100 mg/10 ml)
Product Name: NIVOLUMAB
Product Code: BMS-936558
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: NIVOLUMAB
CAS Number: 946414-94-4
Current Sponsor code: BMS-936558
Other descriptive name: MDX1106, ONO-4538
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Trade Name: Yervoy
Product Name: Ipilimumab
Product Code: BMS-734016
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: IPILIMUMAB
CAS Number: 477202-00-9
Current Sponsor code: BMS-734016
Other descriptive name: BMS734016 / MDX010
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-

Trade Name: PARAPLATIN 450 mg/45 ml solution for infusion
Product Name: Carboplatin
Pharmaceutical Form: Solution for injection
INN or Proposed INN: CARBOPLATIN
Other descriptive name: CARBOPLATIN
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Trade Name: TAXOL 6 mg/ml, concentrate for solution for infusion
Product Name: Paclitaxel
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: PACLITAXEL
CAS Number: 33069-62-4
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 6-

Trade Name: ALIMTA 500 mg powder for concentrate for solution for infusion
Product Name: Pemetrexed
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: PEMETREXED DISODIUM
CAS Number: 150399-23-8
Other descriptive name: PEMETREXED DISODIUM
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-

Trade Name: Cisplatin NeoCorp® 1 mg/ml – Concentrate for solution for infusion
Product Name: Cisplatin
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: CISPLATIN
Other descriptive name: CISPLATIN
Concentration unit: mg/ml milligram(s)/millilitre
Concentrat

Primary Outcome(s)

Primary end point(s): Overall Survival (OS): To compare the efficacy of nivolumab + ipilimumab combined with chemotherapy versus (vs)chemotherapy

Main Objective: To compare the efficacy of nivolumab + ipilimumab with chemotherapy vs chemotherapy in participants with histologically confirmed stage IV NSCLC

Secondary Objective: • To compare the efficacy of nivolumab + ipilimumab combined with chemotherapy vs chemotherapy in participants with histologically confirmed stage IV NSCLC

• To evaluate efficacy outcomes in participants with histologically confirmed stage IV NSCLC treated with nivolumab + ipilimumab combined with chemotherapy vs chemotherapy with different PDL1 expression levels

• To evaluate tumor mutation burden as a potential predictive biomarker of efficacy (such as ORR, PFS and OS) of nivolumab + ipilimumab in combination with chemotherapy using DNA derived from tumor and blood (germline) specimens.

Timepoint(s) of evaluation of this end point: Up to 25 months

Secondary Outcome(s)

Secondary end point(s): Progression Free Survival (PFS): To compare the efficacy of nivolumab + ipilimumab combined with chemotherapy vs chemotherapy
Overall Response Rate (ORR): To compare the efficacy of nivolumab + ipilimumab combined with chemotherapy vs chemotherapy
ORR: In participants with different PD-L1 levels
PFS: In participants with different PD-L1 levels
OS: In participants with different PD-L1 levels
ORR: In association with tumor cell total somatic mutation numbers
PFS: In association with tumor cell total somatic mutation numbers
OS: In association with tumor cell total somatic mutation numbers

Timepoint(s) of evaluation of this end point: Up to 25 months

Secondary ID(s)

NCT03215706

CA209-9LA

Source(s) of Monetary Support

Bristol-Myers Squibb International Corporation