A Neoadjuvant Study of Nivolumab and Ipilimumab compared to Chemotherapy Doublet in Early Stage Non-Small Cell Lung Cancer (NSCLC).

Randomized, Open-Label, Phase 3 Trial of Nivolumab and Ipilimumab versus Platinum-Doublet Chemotherapy in Early Stage NSCLC - CheckMate 816: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 816

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003536-21-ES

Enrollment

326

Registered

2016-12-27

Start date

2017-03-21

Completion date

Unknown

Last updated

2017-04-03

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

Conditions

Early Stage Non-Small Cell Lung Cancer (NSCLC) MedDRA version: 19.0 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Opdivo Product Name: NIVOLUMAB Product Code: BMS-936558 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: NIVOLUMAB CAS Number: 946414-94-4 Current Sponsor co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Early stage (IB - IIIA), operable non-small cell lung cancer, confirmed in tissue. Lung function capacity capable of tolerating the proposed lung surgery Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 Available tissue of primary lung tumor. 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 126 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200

Exclusion criteria

Exclusion criteria: Presence of locally advanced, inoperable or metastatic disease. Participants with active, known or suspected autoimmune disease. Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors).

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the MPR rate by blinded independent pathology review (BIPR) of participants receiving nivolumab and ipilimumab to that of participants receiving platinum doublet chemotherapy in operable stage IB (superior or equal to 4 cm), II, or resectable IIIA (N2) PD-L1+ (superior or equal to 1%) NSCLC;Secondary Objective: To compare the event-free survival (EFS) by blinded independent central review (BICR) in participants receiving nivolumab and ipilimumab to participants receiving platinum doublet chemotherapy in operable stage IB (superior or equal to 4 cm), II, or resectable IIIA (N2) PD-L1+ (superior or equal to 1%) NSCLC To assess the OS of participants receiving nivolumab and ipilimumab to that of participants receiving platinum doublet chemotherapy in operable stage IB (superior or equal to 4 cm), II, or resectable IIIA (N2) PD-L1+ (superior or equal to 1%) NSCLC To assess complete pathological response (pCR) by BIPR of participants receiving nivolumab and ipilimumab compared to participants receiving platinum doublet chemotherapy in operable stage IB (superior or equal to 4 cm), II, or resectable IIIA (N2) PD-L1+ (superior or equal to 1%) NSCLC;Primary end point(s): Major Pathological Response (MPR) rate in subjects with Early Stage NSCLC.;Timepoint(s) of evaluation of this end point: At time of surgery.	—

Measure

Time frame

Main Objective: To compare the MPR rate by blinded independent pathology review (BIPR) of participants receiving nivolumab and ipilimumab to that of participants receiving platinum doublet chemotherapy in operable stage IB (superior or equal to 4 cm), II, or resectable IIIA (N2) PD-L1+ (superior or equal to 1%) NSCLC;Secondary Objective: To compare the event-free survival (EFS) by blinded independent central review (BICR) in participants receiving nivolumab and ipilimumab to participants receiving platinum doublet chemotherapy in operable stage IB (superior or equal to 4 cm), II, or resectable IIIA (N2) PD-L1+ (superior or equal to 1%) NSCLC To assess the OS of participants receiving nivolumab and ipilimumab to that of participants receiving platinum doublet chemotherapy in operable stage IB (superior or equal to 4 cm), II, or resectable IIIA (N2) PD-L1+ (superior or equal to 1%) NSCLC To assess complete pathological response (pCR) by BIPR of participants receiving nivolumab and ipilimumab compared to participants receiving platinum doublet chemotherapy in operable stage IB (superior or equal to 4 cm), II, or resectable IIIA (N2) PD-L1+ (superior or equal to 1%) NSCLC;Primary end point(s): Major Pathological Response (MPR) rate in subjects with Early Stage NSCLC.;Timepoint(s) of evaluation of this end point: At time of surgery.

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Secondary

Measure	Time frame
Secondary end point(s): 1/ Event free survival (EFS) in subjects with Early Stage NSCLC. 2/ Overall survival (OS) in subjects with Early Stage NSCLC. 3/ Complete pathological response (pCR) in subjects with Early Stage NSCLC.;Timepoint(s) of evaluation of this end point: 1/ Up to approximately 130 months after study initiation. 2/ Up to approximately 130 months after study initiation. 3/ At time of surgery.	—

Measure

Time frame

Secondary end point(s): 1/ Event free survival (EFS) in subjects with Early Stage NSCLC. 2/ Overall survival (OS) in subjects with Early Stage NSCLC. 3/ Complete pathological response (pCR) in subjects with Early Stage NSCLC.;Timepoint(s) of evaluation of this end point: 1/ Up to approximately 130 months after study initiation. 2/ Up to approximately 130 months after study initiation. 3/ At time of surgery.

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Countries

Argentina, Brazil, Canada, France, Greece, Hungary, Ireland, Italy, Japan, Netherlands, Romania, South Africa, Spain, Turkey, United Kingdom, United States

Contacts

Public ContactGCT-SU

Bristol-Myers Squibb International Corporation

clinical.trials@bms.com900 150 160

Outcome results

None listed

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