A Study of Nivolumab + Relatlimab Fixed-dose Combination with Chemotherapy Versus Pembrolizumab with Chemotherapy in Participants with Non-squamous Stage IV or Recurrent NSCLC and PD-L1 ≥1%

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Bristol-Myers Squibb Services Unlimited Company

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

4 Jul 2025 → ongoing

Decision date (initial)

2025-06-11

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Bristol-Myers Squibb Services Unlimited Company

External identifiers

EU CT number

2024-513682-40-01

WHO UTN

U1111-1306-8896

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

The main goal of this study is to see if nivolumab+relatlimab FDC (1:1) + chemotherapy allows people to live longer (Overall Survival or OS) than pembrolizumab + chemotherapy for people who have a certain type of lung cancer that has either spread to other parts of the body (Stage IV) or come back after treatment (recurrent).

Secondary objectives 5

1. To see how long people live without their cancer getting worse (PFS or progression free survival)
2. To look at the number of people whose tumors shrink with each treatment (Overall Response Rate or ORR)
3. To see how long it takes for cancer symptoms to get worse (Time to Deterioration or TTD)
4. To monitor how safe the drugs are in Arm A and B participants.
5. check how safe the treatments are and what side effects people may have

Conditions and MedDRA coding

Non-squamous (NSQ), Stage IV or Recurrent Non-small Cell Lung Cancer

Regulatory references

Scientific advice from competent authorities

European Medicines Agency, Food And Drug Administration

Plan to share IPD

Yes

IPD plan description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. The people who can participate in this study are men and women who are 18 years or older.
2. They must have a specific type of lung cancer called non-small cell lung cancer (NSCLC) that is either in stage IV or has come back.
3. This type of cancer has not been treated with any other cancer drugs before.
4. The cancer cells must have a certain amount of a protein called PD-L1, which will be checked in a lab before the study starts.
5. The cancer must be visible on a CT or MRI scan, and these scans must be done within 32 days before receiving study treatment.
6. The participants should be generally healthy, with a score of 1 or less on a scale that measures how well they can do their daily activities.
7. They should also be expected to live for at least 3 months from the start of the study.

Exclusion criteria 6

1. Women who are pregnant or breastfeeding.
2. People who have certain changes in their cancer cells that can be treated with other drugs are also not allowed. Tests are required to determine changes in the EGFR, ALK, ROS-1, and BRAF genes.
3. Patients with known changes in BRAF, RET and NTRK cannot participate.
4. People with cancer that has spread to the brain or the lining of the brain and spinal cord cannot participate.
5. People with another type of cancer that needs treatment, or people with diseases where the body's immune system attacks its own cells, are also not allowed.
6. People who have been treated with certain drugs that affect the immune system, or who have had a heart condition called myocarditis, cannot participate.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Comparison of overall survival in Arm A and Arm B participants.

Secondary endpoints 2

1. Comparison of PFS in Arm A and Arm B participant, as well as evaluation of DoR and ORR in Arm A and B participants.
2. Safety of study drugs administered will be evaluated, along with TTD

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 5

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bristol-Myers Squibb Services Unlimited Company

Sponsor organisation

Bristol-Myers Squibb Services Unlimited Company

Address

Plaza 254 Blanchardstown Corporate Park 2

City

Dublin 15

Postcode

D15 T867

Country

Ireland

Scientific contact point

Organisation

Bristol-Myers Squibb Services Unlimited Company

Contact name

GSM-CT

Public contact point

Organisation

Bristol-Myers Squibb Services Unlimited Company

Contact name

GSM-CT

Third parties 15

Locations

12 EU/EEA countries · 77 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 115 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

17 submissions — initial application plus substantial / non-substantial modifications