A study of Relatlimab plus Nivolumab in combination with chemotherapy versus Nivolumab in combination with chemotherapy in participants with non-small cell lung cancer (NSCLC) stage IV or recurrent.

Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, France, Germany, Ireland, Italy, Mexico, Netherlands, New Zealand, Poland, Romania, Russian Federation, Spain, Switzerland, T?rkiye, United Kingdom, United States (ICTRP)

ID di studio ICTRP
EUCTR2020-004026-31 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
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) (BASEC)

Titolo accademico
A Phase 2 Randomized Double-blind 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) (ICTRP)

Titolo pubblico
A Study of Relatlimab plus Nivolumab in Combination with Chemotherapy vs. Nivolumab in Combination with Chemotherapy in Participants with Stage IV or Recurrent NSCLC (ICTRP)

Malattie studiate
Non Small Cell Lung Cancer
MedDRA version: 20.1Level: LLTClassification code 10025048Term: Lung cancer non-small cell recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 20.0Level: LLTClassification code 10025055Term: Lung cancer non-small cell stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps);Therapeutic area: Diseases [C] - Cancer [C04] (ICTRP)

Intervento studiato

Product Name: Anti-LAG-3-3.7 mL vial
Product Code: BMS-986016
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: relatlimab
Current Sponsor code: BMS-986016
Other descriptive name: BMS986016
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 130-
Pharmaceutical form of the placebo: Concentrate and solvent for concentrate for solution for infusion
Route of administration of the placebo: Intravenous use

Trade Name: Opdivo (100 mg / 10 ml)
Product Name: NIVOLUMAB - 10ml vial COMMERCIAL
Product Code: BMS-936558
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: NIVOLUMAB
CAS Number: 946414-94-4
Current Sponsor code: BMS-936558
Other descriptive name: BMS936558
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Product Name: Carboplatin
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Carboplatin
CAS Number: 41575-94-4
Other descriptive name: CARBOPLATIN
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Product Name: Cisplatin
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Cisplatin
CAS Number: 15663-27-1
Other descriptive name: Cisplatin
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 1-

Product Name: Nab Paclitaxel
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Paclitaxel
Other descriptive name: PACLITAXEL ALBUMIN-BOUND
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Product Name: Paclitaxel
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Paclitaxel
CAS Numb (ICTRP)

Tipo di studio
Interventional clinical trial of medicinal product (ICTRP)

Disegno dello studio
Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2 (ICTRP)

Criteri di inclusione/esclusione
Gender:
Female: yes
Male: yes

Inclusion criteria:
?Males and females; = 18 years of age or local age of majority.
?Histologically confirmed metastatic NSCLC of squamous (SQ) or non-squamous (NSQ) histology with Stage IV or recurrent disease following multi-modal therapy for locally advanced disease.
?Measurable disease by computed tomography or magnetic resonance imaging per Response
?Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria; radiographic tumor assessment performed within 28 days before randomization.
?No prior systemic anti-cancer treatment given as primary therapy for advanced or metastatic disease.
?ECOG PS of less than or equal to 1 at screening and confirmed prior to randomization.
?Participants must have a life expectancy of at least 3 months at the time of first dose.
?A formalin-fixed paraffin-embedded tissue block containing enough tissue to cut 20 sections (preferred) or a minimum of 20 unstained slides of tumor tissue from core biopsy, punch
biopsy, excisional biopsy, or surgical specimen obtained during screening or prior to enrollment (within 3 months of enrollment if stored at 2-8?C or within 2 months of enrollment if stored at ambient temperature and with no intervening systemic anti-cancer treatment between time of acquisition and enrollment) must be sent to the central laboratory.
?Participants must have PD-L1 immunohistochemistry (IHC) results from a central laboratory during the screening period prior to randomization.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 156
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 364
(ICTRP)

Exclusion criteria:
?Women who are pregnant or breastfeeding.
?Participants with EGFR, ALK, or ROS-1 mutations which are sensitive to available targeted inhibitor therapy. All participants with NSQ histology must have been tested for EGFR, ALK, or ROS-1 mutation status. Participants with NSQ histology and unknown EGFR, ALK, or ROS-1 status are excluded.
?Participants with known BRAFV600E mutations that are sensitive to available targeted inhibitor therapy. Participants with unknown or indeterminate BRAF mutation status are
eligible.
?Participants with untreated central nervous system metastases.
?Participants with leptomeningeal metastases (carcinomatous meningitis).
?Concurrent malignancy requiring treatment.
?Participants with an active, known, or suspected autoimmune disease.
?Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-LAG-3, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
?Participants with history of myocarditis.



Endpoint primari e secondari
Main Objective: Part 1
?To evaluate the proportion of participants with TRAEs leading to discontinuation within 12 weeks after the first dose of nivolumab plus 2 different dose levels of relatlimab (360 mg and 720 mg) in combination with PDCT in dose safety evaluable participants with histologically confirmed 1L Stage IV or recurrent NSCLC
Part 2
?To compare PFS of nivolumab plus relatlimab in combination with PDCT vs nivolumab in combination with PDCT in participants with histologically confirmed 1L Stage IV or recurrent NSCLC
;Secondary Objective: Part 1
?To evaluate the safety and tolerability of nivolumab plus 2 different doses of relatlimab (360 mg and 720 mg) in combination with PDCT in all participants with histologically confirmed 1L Stage IV or recurrent NSCLC that were treated during the dose safety confirmation period

Part 2
?To compare PFS of nivolumab plus relatlimab in combination with PDCT vs nivolumab in combination with PDCT in participants with histologically confirmed 1L Stage IV or recurrent NSCLC, in subgroups defined by PD-L1 expression, LAG-3 expression, FG-L1 expression
;Primary end point(s): Part 1
?TRAEs leading to discontinuation within 12 weeks after the first dose

Part 2
?PFS per RECIST v1.1 by BICR
;Timepoint(s) of evaluation of this end point: Part 1
?12 weeks after last patient first dose
Part 2
?Up to 21 months after the first participant is randomized
(ICTRP)

Secondary end point(s): Part 1
?Incidence of TRAEs leading to discontinuation, AEs, SAEs, and select AEs
Part 2
?PFS per RECIST v1.1 by BICR
;Timepoint(s) of evaluation of this end point: Part 1
?12 weeks after last patient first dose
Part 2
?Up to 21 months after the first participant is randomized
(ICTRP)

Data di registrazione
17.10.2024 (ICTRP)

Inclusione del primo partecipante
10.11.2021 (ICTRP)

Sponsor secondari
non disponibile

Contatti aggiuntivi
Head of the GSM-CT, clinical.trials@bms.com, Bristol-Myers Squibb International Corporation (ICTRP)

ID secondari
CA224-104, 2020-004026-31-BE (ICTRP)

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-004026-31 (ICTRP)