A Clinical Study Evaluating Nivolumab-containing Treatments in Patients With Advanced Non-small Cell Lung Cancer After Failing Previous PD-1/(L)1 Therapy and Chemotherapy

Phase 1

Withdrawn

• Conditions: Carcinoma, Non-small Cell Lung Cancer
• Interventions: Biological: nivolumab; Biological: docetaxel; Biological: ipilimumab; Drug: lucitanib; Drug: cabozantinib; Biological: ramucirumab

• Registration Number: NCT04151563
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

This study is for participants with Non-small Cell Lung Cancer that has spread or has reoccurred after failure of Chemotherapy and Immunotherapy

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-01
• Study First Submitted QC: 2019-11-01
• Study First Posted: 2019-11-05
• Study Start: 2021-04-15
• Status Verified: 2023-12
• Primary Completion: 2023-12-17
• Last Update Submitted: 2023-12-17
• Last Update Posted: 2023-12-19
• Study Completion: 2026-05-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A: cabozantinib + nivolumab + ipilimumab	cabozantinib	-
Arm D: lucitanib + nivolumab	nivolumab	-
Arm E: nivolumab + docetaxel	nivolumab	-
Arm B: cabozantinib + nivolumab	nivolumab	-
Arm A: cabozantinib + nivolumab + ipilimumab	nivolumab	-
Arm C: nivolumab + ramucirumab + docetaxel	nivolumab	-
Arm C: nivolumab + ramucirumab + docetaxel	docetaxel	-
Arm C: nivolumab + ramucirumab + docetaxel	ramucirumab	-
Arm A: cabozantinib + nivolumab + ipilimumab	ipilimumab	-
Arm B: cabozantinib + nivolumab	cabozantinib	-
Arm D: lucitanib + nivolumab	lucitanib	-
Arm E: nivolumab + docetaxel	docetaxel	-
Arm F: docetaxel	docetaxel	-

Primary Outcome Measures

Name	Time	Method
Overall Reponse Rate (ORR) using RECIST 1.1 per Blinded Independent Central Review (BICR) assessment	approximately 33 months

Secondary Outcome Measures

Name	Time	Method
Incidence of Adverse Events (AEs)	Up to 5 Years
Incidence of Select AEs	Up to 5 Years
Duration of Response (DOR) by BICR using RECIST 1.1	approximately 33 months
Progression-Free Survival (PFS) by BICR using RECIST 1.1	Up to 5 Years
Incidence of Serious Adverse Events (SAEs)	Up to 5 Years
Overall Survival (OS)	Up to 5 Years

Trial Locations

Locations (1)

Local Institution; 🇷🇴 Timisoara, Romania