What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) involving immune checkpoint inhibitors like Nivolumab (PD-1 Inhibitor) and chemotherapy can lead to a range of side effects. Nivolumab can cause immune-related adverse events such as pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. Chemotherapy, often combined with these inhibitors, can result in nausea, vomiting, fatigue, neutropenia, and increased risk of infections. The combination of these treatments may also lead to more severe side effects, including grade 3-4 toxicities like severe diarrhea, pneumonitis, and infusion-related reactions.

What prior FDA approvals exist?

The FDA has approved several immunotherapy drugs for the treatment of Non-Small Cell Lung Cancer (NSCLC). Nivolumab, a PD-1 inhibitor, has been approved for use in patients with metastatic NSCLC whose disease progressed after platinum-based chemotherapy, showing improved overall survival and response rates compared to docetaxel. Pembrolizumab, another PD-1 inhibitor, has been approved for use in combination with chemotherapy for first-line treatment of metastatic NSCLC, demonstrating significant improvements in overall survival and progression-free survival. Atezolizumab, a PD-L1 inhibitor, has also been approved for patients with metastatic NSCLC following progression on platinum-containing chemotherapy. These approvals highlight the effectiveness of immune checkpoint inhibitors in treating advanced NSCLC.

What other types of research exist?

Promising alternatives to Relatlimab and Nivolumab for NSCLC patients include: 1) Pembrolizumab (PD-1 inhibitor) combined with chemotherapy, which has shown improved overall survival in patients with PD-L1 expression. 2) Atezolizumab (PD-L1 inhibitor) combined with bevacizumab and chemotherapy, which has demonstrated benefits in progression-free and overall survival. 3) Elraglusib, a GSK-3 beta inhibitor, which may reduce the intensity of anti-PD-1 treatment needed and enhance T cell cytolytic activity. 4) Lorlatinib, for patients with ROS1-positive NSCLC, which has shown efficacy in advanced stages. These alternatives offer different mechanisms of action and combination strategies that could be beneficial for NSCLC treatment.

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Alkylating agents

Relatlimab + Nivolumab + Chemotherapy for Lung Cancer

Phase 2

Waitlist Available

Research Sponsored by Bristol-Myers Squibb

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status (PS) of less than or equal to 1 at screening and confirmed prior to randomization

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

Must not have

Participants with EGFR, ALK, ROS-1, or known B-rapidly accelerated fibrosarcoma proto-oncogene (BRAF V600E) mutations that are sensitive to available targeted therapy

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment combining two immunotherapy drugs (relatlimab and nivolumab) with standard chemotherapy. It targets patients with advanced or recurrent lung cancer. The goal is to see if this combination improves outcomes compared to using just one immunotherapy drug with chemotherapy. Nivolumab has shown improved survival in the treatment of advanced non-small-cell lung cancer (NSCLC) previously treated with chemotherapy.

Who is the study for?

This trial is for adults with Stage IV or recurrent non-small cell lung cancer (NSCLC) who haven't had systemic anti-cancer treatment for advanced disease. They should have a good performance status, meaning they're fairly active and can care for themselves. People with certain gene mutations treatable by targeted therapy, untreated brain metastases, another active cancer, or previous immunotherapy are excluded.

What is being tested?

The study tests the effectiveness of Relatlimab combined with Nivolumab and chemotherapy versus just Nivolumab with chemotherapy in treating NSCLC. It aims to see if adding Relatlimab improves response rates compared to the current standard which includes Nivolumab.

What are the potential side effects?

Potential side effects include reactions related to immune system activation such as inflammation in various organs like lungs or intestines, skin rashes, hormone gland problems (like thyroid), fatigue, nausea from chemotherapy drugs used alongside these treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or have some restrictions but can still care for myself.

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I haven't received any systemic anti-cancer treatments for my advanced cancer.

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My lung cancer is confirmed to be advanced or has come back and is either SQ or NSQ type.

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My cancer can be measured on scans.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has specific mutations (EGFR, ALK, ROS-1, BRAF V600E) treatable with targeted therapy.

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I have previously been treated with specific immunotherapy drugs.

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My cancer has spread to the lining of my brain and spinal cord.

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I have brain metastases that have not been treated.

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I do not have any other cancers needing treatment or that were active in the last 2 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded independent clinical review (BICR)

Treatment-related adverse events (TRAEs) leading to discontinuation within 12 weeks after the first dose

Secondary study objectives

Duration of Response (DoR) per RECIST v1.1 by BICR

Incidence of Adverse Events (AEs)

Incidence of Immune-mediated Adverse Events (IMAEs)

+6 more

Side effects data

From 2023 Phase 1 & 2 trial • 62 Patients • NCT03310619

71%

White blood cell count decreased

65%

Neutrophil count decreased

59%

Anaemia

59%

Lymphocyte count decreased

53%

Platelet count decreased

41%

Cytokine release syndrome

29%

Neutropenia

29%

Decreased appetite

18%

Diarrhoea

18%

Vomiting

18%

Muscular weakness

18%

Dizziness

18%

Neurotoxicity

18%

Insomnia

18%

Pleural effusion

18%

Hypertension

12%

Pyrexia

12%

Hypoxia

12%

Febrile neutropenia

12%

Thrombocytopenia

12%

Tachycardia

12%

Conjunctival haemorrhage

12%

Fatigue

12%

Pain

12%

Contusion

12%

Hyperuricaemia

12%

Hypokalaemia

12%

Hypomagnesaemia

12%

Tremor

12%

Dyspnoea

12%

Pruritus

Appetite disorder

Extrasystoles

Hypercalcaemia

Atrial fibrillation

Blood creatinine increased

Enteritis

COVID-19

Pneumonia

Agraphia

Large intestine perforation

Hypofibrinogenaemia

Supraventricular extrasystoles

Ventricular tachycardia

Periorbital oedema

Visual impairment

Abdominal distension

Abdominal pain

Anal incontinence

Constipation

Dry mouth

Gastrointestinal disorder

Oedema

Oedema peripheral

Physical deconditioning

Jaundice

Ocular icterus

Conjunctivitis

Cytomegalovirus infection reactivation

Urinary tract infection

Fall

Alanine aminotransferase increased

Blood bilirubin increased

Dehydration

Hypocalcaemia

Hypophosphataemia

Arthralgia

Musculoskeletal chest pain

Amnesia

Peroneal nerve palsy

Anxiety

Confusional state

Urinary retention

Cough

Oropharyngeal pain

Night sweats

Seborrhoeic dermatitis

Deep vein thrombosis

Haematoma

Hypotension

100%

80%

60%

40%

20%

Study treatment Arm

Arm D: Cohort 1A JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion)

Arm F: Cohort 1A Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)

Arm A: Cohort 1A JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)

Arm A: Cohort 1B JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)

Arm B: Cohort 1A JCAR017 Plus CC-122 (Post-JCAR017 Infusion)

Arm C: Cohort 1A JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion)

Arm E: Cohort 1C JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion)

Arm F: Cohort 1D Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Part 2: Arm C (Nivolumab + Relatlimab Dose 2 + PDCT)Experimental Treatment6 Interventions

Group II: Part 1: Arm B (Nivolumab + Relatlimab Dose 2 + PDCT))Experimental Treatment7 Interventions

Group III: Part 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT))Experimental Treatment7 Interventions

Group IV: Part 2: Arm D (Nivolumab + PDCT)Active Control5 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cisplatin

2013

Completed Phase 3

~3120

Paclitaxel

2011

Completed Phase 4

~5370

Nab-Paclitaxel

2014

Completed Phase 3

~4540

Pemetrexed

2014

Completed Phase 3

~5550

Carboplatin

2014

Completed Phase 3

~6120

Nivolumab

2015

Completed Phase 3

~4010

Relatlimab

2019

Completed Phase 2

~1150

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Immunotherapies such as Relatlimab and Nivolumab are pivotal in treating Non-Small Cell Lung Cancer (NSCLC) by enhancing the immune system's ability to fight cancer. Relatlimab, a LAG-3 inhibitor, prevents the suppression of T cells, while Nivolumab, a PD-1 inhibitor, stops cancer cells from evading immune detection. These mechanisms are significant for NSCLC patients as they can lead to improved response rates and survival outcomes by enabling a more robust immune attack on cancer cells.

Large Cell Neuro-Endocrine Carcinoma of the Lung: Current Treatment Options and Potential Future Opportunities.Emerging therapeutic agents for lung cancer.