A study of nivolumab and ipilimumab in untreated patients with stage 3 NSCLC that is unable or not planned to be removed by surgery

A Phase 3, Randomized, Open Label Study to Compare Nivolumab plus Concurrent Chemoradiotherapy (CCRT) followed by Nivolumab plus Ipilimumab or Nivolumab plus CCRT Followed by Nivolumab vs CCRT followed by Durvalumab in Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) - CheckMate73L

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001222-98-BE

Enrollment

1400

Registered

2019-07-22

Start date

2019-08-28

Completion date

Unknown

Last updated

2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Previously Untreated Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) MedDRA version: 21.1 Level: PT Classification code 10029519 Term: Non-small cell lung cancer stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Eastern Cooperative Oncology Group (ECOG) performance status =1 - Locally advanced stage IIIA, IIIB, or IIIC (T1-2 N2-3 M0, T3 N1-3 M0, or T4 N0-3 M0) pathologically-confirmed NSCLC, according to 8th TNM classification - Newly diagnosed and treatment-naïve, with no prior local or systemic anticancer therapy given as primary therapy for locally advanced disease Other protocol defined inclusion criteria could apply 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 770 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 630

Exclusion criteria

Exclusion criteria: - Any condition including medical, emotional, psychiatric, or logistical that, in the opinion of the Investigator would preclude the participant from adhering to the protocol or would increase the risk associated with study treatment - Active infection requiring systemic therapy within 14 days prior to randomization - History of organ or tissue transplant that requires systemic use of immune suppressive agents. - Prior thoracic radiotherapy Other protocol defined exclusion criteria could apply

Design outcomes

Primary

Measure	Time frame
Main Objective: - To compare progression-free survival (PFS) for Arm A vs Arm C;Secondary Objective: - To compare OS for Arm A vs Arm C -To evaluate PFS and OS for Arm B vs Arm C and Arm A vs Arm B - To evaluate tumor response for Arm A vs Arm C, Arm B vs Arm C, and Arm A vs Arm B according to BICR assessment - To evaluate PFS and tumor response for Arm A vs Arm C, Arm B vs Arm C, and Arm A vs Arm B according to Investigator assessment of tumor imaging - To evaluate time to death or distant metastases (TTDM) for Arm A vs Arm C, Arm B vs Arm C, and Arm A vs Arm B according to Investigator assessment of tumor imaging - To assess safety and tolerability of study treatments - To evaluate symptom deterioration for Arm A vs Arm C, Arm B vs Arm C, and Arm A vs Arm B ;Primary end point(s): 1. Progression Free Survival (PFS) Assessed by RECIST 1.1 per Blinded Independent Central Review (BICR) ;Timepoint(s) of evaluation of this end point: 1. Up to 5 Years	—

Measure

Time frame

Main Objective: - To compare progression-free survival (PFS) for Arm A vs Arm C;Secondary Objective: - To compare OS for Arm A vs Arm C -To evaluate PFS and OS for Arm B vs Arm C and Arm A vs Arm B - To evaluate tumor response for Arm A vs Arm C, Arm B vs Arm C, and Arm A vs Arm B according to BICR assessment - To evaluate PFS and tumor response for Arm A vs Arm C, Arm B vs Arm C, and Arm A vs Arm B according to Investigator assessment of tumor imaging - To evaluate time to death or distant metastases (TTDM) for Arm A vs Arm C, Arm B vs Arm C, and Arm A vs Arm B according to Investigator assessment of tumor imaging - To assess safety and tolerability of study treatments - To evaluate symptom deterioration for Arm A vs Arm C, Arm B vs Arm C, and Arm A vs Arm B ;Primary end point(s): 1. Progression Free Survival (PFS) Assessed by RECIST 1.1 per Blinded Independent Central Review (BICR) ;Timepoint(s) of evaluation of this end point: 1. Up to 5 Years

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Secondary

Measure	Time frame
Secondary end point(s): 2. OS for Arm A vs Arm C 3. Overall Survival (OS) for Arm B and Arm C 4. Progression-free survival (PFS) by RECIST 1.1 per Blinded Independent Central Review (BICR) for Arm B and Arm C 5. Overall Survival (OS) for Arm A and Arm B 6. Progression-free survival (PFS) by RECIST 1.1 per Blinded Independent Central Review (BICR) for Arm A and Arm B 7. Objective Response Rate (ORR) by RECIST 1.1 per Blinded Independent Central Review (BICR) 8. Duration of Response (DoR) by RECIST 1.1 per Blinded Independent Central Review (BICR) 9. Time to Response (TTR) by RECIST 1.1 per Blinded Independent Central Review (BICR) 10. Progression-free survival (PFS) by RECIST 1.1 per investigator assessment 11. Objective response rate (ORR) by RECIST 1.1 per investigator assessment 12. DoR by RECIST 1.1 per investigator assessment 13. TTR by RECIST 1.1 per investigator assessment 14. Time to death or distant metastases (TTDM) by RECIST 1.1 per Investigator assessment 15. Incidence of adverse events (AEs) 16. Incidence of serious adverse events (SAEs) 17. Proportion of participants without symptom deterioration based on NSCLC-SAQ ;Timepoint(s) of evaluation of this end point: 2. Up to 5 years 3. Up to 55 Months 4. Up to 40 Months 5. Up to 50 Months 6. Up to 40 Months 7. Up to 7,5 Years 8. Up to 7,5 Years 9. Up to 7,5 Years 10. Up to 40 Months 11. Up to 7,5 Years 12. Up to 7,5 Years 13. Up to 7,5 Years 14. Up to 7,5 Years 15. Up to 5 Years 16. Up to 5 Years 17. 48 Weeks	—

Measure

Time frame

Secondary end point(s): 2. OS for Arm A vs Arm C 3. Overall Survival (OS) for Arm B and Arm C 4. Progression-free survival (PFS) by RECIST 1.1 per Blinded Independent Central Review (BICR) for Arm B and Arm C 5. Overall Survival (OS) for Arm A and Arm B 6. Progression-free survival (PFS) by RECIST 1.1 per Blinded Independent Central Review (BICR) for Arm A and Arm B 7. Objective Response Rate (ORR) by RECIST 1.1 per Blinded Independent Central Review (BICR) 8. Duration of Response (DoR) by RECIST 1.1 per Blinded Independent Central Review (BICR) 9. Time to Response (TTR) by RECIST 1.1 per Blinded Independent Central Review (BICR) 10. Progression-free survival (PFS) by RECIST 1.1 per investigator assessment 11. Objective response rate (ORR) by RECIST 1.1 per investigator assessment 12. DoR by RECIST 1.1 per investigator assessment 13. TTR by RECIST 1.1 per investigator assessment 14. Time to death or distant metastases (TTDM) by RECIST 1.1 per Investigator assessment 15. Incidence of adverse events (AEs) 16. Incidence of serious adverse events (SAEs) 17. Proportion of participants without symptom deterioration based on NSCLC-SAQ ;Timepoint(s) of evaluation of this end point: 2. Up to 5 years 3. Up to 55 Months 4. Up to 40 Months 5. Up to 50 Months 6. Up to 40 Months 7. Up to 7,5 Years 8. Up to 7,5 Years 9. Up to 7,5 Years 10. Up to 40 Months 11. Up to 7,5 Years 12. Up to 7,5 Years 13. Up to 7,5 Years 14. Up to 7,5 Years 15. Up to 5 Years 16. Up to 5 Years 17. 48 Weeks

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Countries

Argentina, Australia, Belgium, Brazil, Canada, Chile, China, France, Germany, Greece, Ireland, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Poland, Romania, Russian Federation, Singapore, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States

Contacts

Public ContactGSM-CT

Bristol-Myers Squibb International Corporation

clinical.trials@bms.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026