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Completed

NCT Number: NCT04623775

A Study of Relatlimab Plus Nivolumab in Combination With Chemotherapy vs. Nivolumab in Combination With Chemotherapy as First Line Treatment for Participants With Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)

The purpose of this study is to assess the safety profile of relatlimab plus nivolumab in combination with platinum doublet chemotherapy (PDCT) and to determine if nivolumab plus relatlimab in combination with PDCT improves overall response rate (ORR) when compared to nivolumab plus PDCT in participants with previously untreated Stage IV or recurrent non-small cell lung cancer (NSCLC).

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Metastatic Non-small Cell Lung Cancer Neoplasms Neoplasms by Site Recurrent Non-small Cell Lung Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution - 0037, Río Cuarto, Córdoba Province, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed metastatic non-small cell lung cancer (NSCLC) of squamous (SQ) or non-squamous (NSQ) histology with Stage IV A/B (as defined by the 8th International Association for the Study of Lung Cancer Classification) or recurrent disease following multi-modal therapy for locally advanced disease.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of less than or equal to 1 at screening and confirmed prior to randomization.
  • Measurable disease by computed tomography (CT) or magnetic resonance resources (MRI) per response evaluation criteria in solid tumor version 1.1 (RECIST 1.1) criteria.
  • No prior systemic anti-cancer treatment (including epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) inhibitors) given as primary therapy for advanced or metastatic disease.

Exclusion criteria

  • Participants with EGFR, ALK, ROS-1, or known B-rapidly accelerated fibrosarcoma proto-oncogene (BRAF V600E) mutations that are sensitive to available targeted therapy.
  • Untreated CNS metastases.
  • Leptomeningeal metastases (carcinomatous meningitis).
  • Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to randomization (ie, participants with a history of prior malignancy are eligible if treatment was completed at least 2 years before randomization and the participant has no evidence of disease).
  • Prior treatment with an anti-programmed cell death protein 1 (PD-1), anti-programmed death-ligand 1 (PD-L1), anti-programmed death-ligand 2 (PD-L2), or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Treatment and study plan

Nivolumab

Biological

Specified dose on specified days

Relatlimab

Biological

Specified dose on specified days

carboplatin

Drug

Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.

Cisplatin

Drug

Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.

paclitaxel

Drug

Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.

Nab-paclitaxel

Drug

Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.

Pemetrexed

Drug

Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.

Primary outcomes

  1. TRAEs Leading to Discontinuation Within 12 Weeks of First Dose in Part 1

    Time frame: from first dose to 12 weeks after first dose

    Percentage of participants with treatment related adverse events (TRAEs) leading to discontinuation within 12 weeks of first dose.

    AE is defined as any new untoward medical occurrence or worsenig of a preexising medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.

    Grading will be determined for severity according to the NCI CTCAE v5.0.

  2. ORR Per RECISTS v1.1 by BICR in Part 2

    Time frame: Approximately 14.8 Months

    Objective Response Rate (ORR) per RECIST v1.1 by BICR is defined as the number of participants in the randomized population who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) based on BICR assessments (using RECIST v1.1) divided by the number of participants in the population. BOR is defined as the best response, as determined by the BICR, recorded between the date of randomization and the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first.

Secondary outcomes

  1. TRAEs Leading to Discontinuation in Part 1

    Time frame: From first dose to 30 days post last dose of study therapy (Approximately 32.8 Months)

    Number of participants with treatment related adverse events (TRAEs) leading to discontinuation based on grade.

    AE is defined as any new untoward medical occurrence or worsenig of a preexising medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.

    Grading will be determined for severity according to the NCI CTCAE v5.0

  2. Number of Participants With a Treatment Related AEs in Part 1

    Time frame: From first dose to 30 days post last dose of study therapy (Approximately 32.8 Months)

    Number of participants with a treatment related AE in part 1.

    AE is defined as any new untoward medical occurrence or worsenig of a preexising medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.

    Grading will be determined for severity according to the NCI CTCAE v5.0

  3. Number of Participants With Treatment Releted SAEs in Part 1

    Time frame: From first dose to 30 days post last dose of study therapy (Approximately 32.8 Months)

    A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose, results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event (defined as a medical event(s) that may not be immediately life-threatening or result in death or hospitalization but, based upon appropriate medical and scientific judgment, may jeopardize the participant or may require intervention [e.g., medical, surgical] to prevent one of the other serious outcomes listed in the definition).

    Grading will be determined for severity according to the NCI CTCAE v5.0.

  4. Number of Participants With Treatment Releted Select AEs in Part 1

    Time frame: From first dose to 30 days post last dose of study therapy (Approximately 32.8 Months)

    AE is defined as any new untoward medical occurrence or worsenig of a preexising medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.

    Select Adverse Events (AEs) will be determined for severity according to the NCI CTCAE v5.0.

  5. ORR by PD-L1 Expression Per RECISTS v1.1 by BICR in Part 2

    Time frame: Approximately 14.8 Months

    Objective Response Rate (ORR) per RECIST v1.1 by BICR is defined as the number of participants in the randomized population who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) based on BICR assessments (using RECIST v1.1) divided by the number of participants in the population. BOR is defined as the best response, as determined by the BICR, recorded between the date of randomization and the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first.

  6. DoR Per RECISTS v1.1 by BICR in Part 2

    Time frame: Approximately up to 13.7 months

    Duration of Response (DOR) will be assessed by BICR. It is defined as the time between the date of first documented response (CR or PR) that is subsequently confirmed, to the date of the first objectively documented tumor progression as determined by the BICR (per RECIST v1.1), or death due to any cause, whichever occurs first.

  7. Number of Participants With a AE in Part 2

    Time frame: From first dose to 30 days post last dose of study therapy (Approximately 14.8 Months)

    Number of participants with an adverse event (AE).

    AE is defined as any new untoward medical occurrence or worsenig of a preexising medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.

    Grading will be determined for severity according to the NCI CTCAE v5.0.

  8. Number of Participants With a Treatment Related AEs in Part 2

    Time frame: From first dose to 30 days post last dose of study therapy (Approximately 14.8 Months)

    AE is defined as any new untoward medical occurrence or worsenig of a preexising medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.

    Grading will be determined for severity according to the NCI CTCAE v5.0.

  9. Number of Participants With a Treatment Related SAEs in Part 2

    Time frame: From first dose to 30 days post last dose of study therapy (Approximately 14.8 Months)

    SAE is defined as a life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe). SAEs can also result in death. The AE requires inpatient hospitalization or causes prolongation of existing hospitalization. Results in persistent or significant disability/incapacity. Is a congenital anomaly/birth defect. Is an important medical event (defined as a medical event(s) that may not be immediately lifethreatening or result in death or hospitalization but, based upon appropriate medical and scientific judgment, may jeopardize the participant or may require intervention [e.g., medical, surgical] to prevent one of the other serious outcomes listed in the definition above.)

    Grading will be determined for severity according to the NCI CTCAE v5.0.

  10. Number of Participants With Endocrine Immune-mediated Adverse Events in Part 2

    Time frame: From first dose to 30 days post last dose of study therapy (Approximately 14.8 Months)

    IMAEs are AEs consistent with an immune-mediated mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include events with an alternate etiology which were exacerbated by the induction of autoimmunity.

    Grading will be determined for severity according to the NCI CTCAE v5.0.

  11. ORR by LAG-3 Expression Per RECISTS v1.1 by BICR in Part 2

    Time frame: On Going

    Objective Response Rate (ORR) per RECIST v1.1 by BICR is defined as the number of participants in the randomized population who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) based on BICR assessments (using RECIST v1.1) divided by the number of participants in the population. BOR is defined as the best response, as determined by the BICR, recorded between the date of randomization and the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first.

  12. ORR by FG-L1 Expression Per RECISTS v1.1 by BICR in Part 2

    Time frame: Ongoing

    Objective Response Rate (ORR) per RECIST v1.1 by BICR is defined as the number of participants in the randomized population who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) based on BICR assessments (using RECIST v1.1) divided by the number of participants in the population. BOR is defined as the best response, as determined by the BICR, recorded between the date of randomization and the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first.

  13. PFS Per RECISTS v1.1 by BICR in Part 2

    Time frame: Ongoing

    Progression Free Survival is defined as the time between the date of randomization and the first date of documented progression, based on BICR assessments (per RECIST v1.1), or death due to any cause, whichever occurs first.

  14. PFS by PD-L1 Expression Per RECISTS v1.1 by BICR in Part 2

    Time frame: Ongoing

    Progression Free Survival is defined as the time between the date of randomization and the first date of documented progression, based on BICR assessments (per RECIST v1.1), or death due to any cause, whichever occurs first.

  15. PFS by LAG-3 Expression Per RECISTS v1.1 by BICR in Part 2

    Time frame: Ongoing

    Progression Free Survival is defined as the time between the date of randomization and the first date of documented progression, based on BICR assessments (per RECIST v1.1), or death due to any cause, whichever occurs first.

  16. PFS by FG-L1 Expression Per RECISTS v1.1 by BICR in Part 2

    Time frame: Ongoing

    Progression Free Survival is defined as the time between the date of randomization and the first date of documented progression, based on BICR assessments (per RECIST v1.1), or death due to any cause, whichever occurs first.

  17. Number of Participants With Treatment Releted Select AEs in Part 2

    Time frame: Ongoing

    AE is defined as any new untoward medical occurrence or worsenig of a preexising medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.

    Select Adverse Events (AEs) will be determined for severity according to the NCI CTCAE v5.0.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 2 Randomized Study of Relatlimab Plus Nivolumab in Combination With Chemotherapy vs. Nivolumab in Combination With Chemotherapy as First Line Treatment for Participants With Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
Nov 10, 2020
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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