A Study of Nivolumab and Ipilimumab Combined With Chemotherapy Compared to Chemotherapy Alone in First Line NSCLC

• Register: ClinicalTrials.gov
• Last refreshed on: 15 January 2024
• Main ID: NCT03215706
• Date of registration: 11/07/2017
• Prospective Registration: Yes
• Primary sponsor: Bristol-Myers Squibb
• Public title: A Study of Nivolumab and Ipilimumab Combined With Chemotherapy Compared to Chemotherapy Alone in First Line NSCLC CheckMate 9LA
• Scientific title: A Phase 3, Randomized Study of Nivolumab Plus Ipilimumab in Combination With Chemotherapy vs Chemotherapy Alone as First Line Therapy in Stage IV Non-Small Cell Lung Cancer
• Date of first enrolment: August 24, 2017
• Target sample size: 719
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03215706
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

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

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion criteria

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

Inclusion Criteria:

- Participants with histologically confirmed Stage IV or recurrent NSCLC squamous or
non-squamous histology, with no prior systemic anticancer therapy

- Eastern Cooperative Oncology Group (ECOG) Performance Status of = 1

- Measurable disease by CT or MRI per response evaluation criteria in solid tumors
version 1.1 (RECIST 1.1) criteria

- Participants must have PD-L1 IHC testing with results performed by a central
laboratory during the screening period

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: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Non-Small Cell Lung Cancer

Intervention(s)

Drug: Carboplatin

Biological: Ipilimumab

Biological: Nivolumab

Drug: Cisplatin

Drug: Pemetrexed

Drug: Paclitaxel

Primary Outcome(s)

Overall Survival (OS) [Time Frame: From date of randomization to date of death (assessed up to October 2019, approximately 23 months)]

Secondary Outcome(s)

OS by PD-L1 Tumor Cell Expression [Time Frame: From date of randomization to date of death (assessed up to October 2019, approximately 23 months)]

Objective Response Rate (ORR) by BICR [Time Frame: From date of randomization until date of documented tumor progression or subsequent anti-cancer therapy, whichever occurs first (assessed up to October 2019, approximately 23 months)]

Objective Response Rate (ORR) by BICR by PD-LI Tumor Cell Expression [Time Frame: From date of randomization until date of documented tumor progression or subsequent anti-cancer therapy, whichever occurs first (assessed up to October 2019, approximately 23 months)]

Progression Free Survival (PFS) by BICR [Time Frame: From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2019, approximately 23 months)]

Time to Response (TTR) [Time Frame: From date of randomization to date of first confirmed documented response (assessed up to October 2019, approximately 23 months)]

Duration of Response (DoR) [Time Frame: From date of first confirmed response to date of tumor progression (assessed up to October 2019, approximately 23 months)]

PFS by BICR by PD-L1 Tumor Cell Expression [Time Frame: From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2019, approximately 23 months)]

Secondary ID(s)

CA209-9LA

2017-001195-35

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 16/09/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03215706