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RecruitingLast updated: 17 February 2025

RELATIVITY1093: This study is recruiting people with stage IV or recurrent non-squamous non-small cell lung cancer to compare the effectiveness of two immunotherapy and chemotherapy treatment combinationsA Phase 3, Randomized, Open-label Study of Nivolumab + Relatlimab Fixed-dose Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy as First-line Treatment for Participants With Non-squamous (NSQ), Stage IV or Recurrent Non-small Cell Lung Cancer and With Tumor Cell PD-L1 Expression of 1% to 49%

Trial purpose

Medical clipboardCancer treatment

Tumor type

Lung Cancers Lung cancer

Age

People18+

Trial acronym

RELATIVITY1093

Clinical summary

Summary

This study is recruiting people with non-squamous, stage IV or recurrent non-small cell lung cancer with tumour cell PD-L1 expression of 1% to 49%.

It is comparing the efficacy of nivolumab + relatlimab in combination with chemotherapy, to pembrolizumab in combination with chemotherapy. 

Eligible participants will be randomly allocated to one of two treatment arms.

In the Experimental Arm, participants will receive Nivolumab + Relatlimab immunotherapy, in combination with Carboplatin, Pemetrexed and Cisplatin chemotherapy. 

In the Active Comparator Arm, participants will receive Pembrolizumab immunotherapy in combination with Carboplatin, Pemetrexed and Cisplatin chemotherapy. 

Conditions

This trial is treating people with non-squamous, non-small cell lung cancer who have not had prior treatment for their advanced or metastatic disease

Eligibility

Inclusion

  • Participants must have histologically confirmed Stage IV or recurrent Non-small Cell Lung Cancer (NSCLC) of non-squamous (NSQ) histology with tumor cell PD-L1 expression 1% to 49% as determined by a central laboratory
  • Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1 criteria.
  • Participants must have an Easter Cooperative Oncology Group (ECOG) performance status of ≤ 1 at screening.
  • Participants must have no prior systemic anti-cancer treatment given as primary therapy for advanced or metastatic disease.

Exclusion

  • Participants must not have epidermal growth factor receptor (EGFR) mutations, anaplastic lymphoma kinase (ALK) translocations, ROS-1 translocations and known BRAFV600E, that are sensitive to available targeted inhibitor therapy; participants with known activating rearranged during transfection (RET) mutations and neurotrophic tyrosine receptor kinase (NTRK) fusion gene alterations.
  • Participants must not have untreated central nervous system (CNS) metastases.
  • Participants must not have concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to randomization.
  • Participants must not have an active autoimmune disease.
  • Participants must not have history of interstitial lung disease or pneumonitis that required oral or intravenous (IV) glucocorticoids.
  • Participants must not have a history of myocarditis, regardless of etiology.
  • Participants must not have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or other antibody or drug targeting T-cell co-stimulation or checkpoint pathways.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body (localised).

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Bristol-Myers Squibb

Scientific Title

A Phase 3, Randomized, Open-label Study of Nivolumab + Relatlimab Fixed-dose Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy as First-line Treatment for Participants With Non-squamous (NSQ), Stage IV or Recurrent Non-small Cell Lung Cancer and With Tumor Cell PD-L1 Expression of 1% to 49%

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