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Active Clinical Trials

A Study of Nivolumab and Ipilimumab Combined With Chemotherapy Compared to Chemotherapy Alone in First Line NSCLC (CheckMate 9LA)

Active NCT:
03215706
Allegheny Valley Hospital
Allegheny Valley Hospital

Allegheny General Hospital
Allegheny General Hospital

Forbes Hospital
Forbes Hospital

Jefferson Hospital
Jefferson Hospital

West Penn Hospital
West Penn Hospital

Wexford Health + Wellness Pavilion
Wexford Health + Wellness Pavilion

Category:
Cancer - Lung
Sponsor: 
Bristol-Myers Squibb
Contact: 

For more information, please contact Mara Yerk at 412-578-5393 or Mara.Yerk@ahn.org.

CA2099LA: 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 (NSCLC) (CHECKMATE 9LA)

Purpose: 

The purpose of this study is to determine whether Nivolumab, Ipilimumab combined with chemotherapy is more effective than chemotherapy by itself when treating stage IV NSCLC as the first treatment given for the disease.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

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