NCT04151563

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

Trial Health

42
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2021

Longer than P75 for phase_1

Geographic Reach
10 countries

23 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 5, 2019

Completed
1.4 years until next milestone

Study Start

First participant enrolled

April 15, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2023

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 13, 2026

Completed
Last Updated

December 19, 2023

Status Verified

December 1, 2023

Enrollment Period

2.7 years

First QC Date

November 1, 2019

Last Update Submit

December 17, 2023

Conditions

Carcinoma, Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall Reponse Rate (ORR) using RECIST 1.1 per Blinded Independent Central Review (BICR) assessment

    approximately 33 months

Secondary Outcomes (6)

  • Overall Survival (OS)

    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 Adverse Events (AEs)

    Up to 5 Years

  • Incidence of Serious Adverse Events (SAEs)

    Up to 5 Years

  • +1 more secondary outcomes

Study Arms (6)

Arm A: cabozantinib + nivolumab + ipilimumab

EXPERIMENTAL
Biological: nivolumabBiological: ipilimumabDrug: cabozantinib

Arm B: cabozantinib + nivolumab

EXPERIMENTAL
Biological: nivolumabDrug: cabozantinib

Arm C: nivolumab + ramucirumab + docetaxel

EXPERIMENTAL
Biological: nivolumabBiological: docetaxelBiological: ramucirumab

Arm D: lucitanib + nivolumab

EXPERIMENTAL
Biological: nivolumabDrug: lucitanib

Arm E: nivolumab + docetaxel

EXPERIMENTAL
Biological: nivolumabBiological: docetaxel

Arm F: docetaxel

ACTIVE COMPARATOR
Biological: docetaxel

Interventions

nivolumabBIOLOGICAL

Specified dose on Specified days

Also known as: OPDIVO, BMS-936558
Arm A: cabozantinib + nivolumab + ipilimumabArm B: cabozantinib + nivolumabArm C: nivolumab + ramucirumab + docetaxelArm D: lucitanib + nivolumabArm E: nivolumab + docetaxel
ipilimumabBIOLOGICAL

Specified dose on Specified days

Also known as: YERVOY
Arm A: cabozantinib + nivolumab + ipilimumab
cabozantinibDRUG

Specified dose on Specified days

Also known as: CABOMETYX
Arm A: cabozantinib + nivolumab + ipilimumabArm B: cabozantinib + nivolumab
docetaxelBIOLOGICAL

Specified dose on Specified days

Arm C: nivolumab + ramucirumab + docetaxelArm E: nivolumab + docetaxelArm F: docetaxel
ramucirumabBIOLOGICAL

Specified dose on Specified days

Also known as: CYRAMZA
Arm C: nivolumab + ramucirumab + docetaxel
lucitanibDRUG

Specified dose on Specified days

Also known as: CO-3810
Arm D: lucitanib + nivolumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically-documented Stage IV A/B non-small cell lung Cancer, stage IIIB/C disease failed concurrent chemoRT.
  • ECOG Performance Status of ≤ 1.
  • Radiologically-documented disease progression on one anti-PD-1/anti-PD-L1 therapy and one platinum-based doublet regimen given either concurrently or sequentially within 90 days after the last dose of anti-PD-(L)1.
  • All participants must have tumor tissue submitted prior to randomization, either a recent archival sample obtained on/after the date of disease progression of the last prior anticancer therapy and within 3 months prior to enrollment, or a fresh biopsy obtained during the screening period.
  • Prior toxicities must have resolved to grade ≤1.
  • Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test and must not be breastfeeding.
  • Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception. In addition, male participants must be willing to refrain from sperm donation during this time and must agree to follow instructions for method(s) of contraception. Azoospermic males are exempt from contraceptive requirements as well as WOCBP who are continuously not heterosexually active, however, a pregnancy test will still be required.

You may not qualify if:

  • Prior treatment with Docetaxel.
  • Untreated CNS metastases, carcinomatous meningitis or leptomeningeal metastases.
  • Any tumor invading the Superior Vena Cava other blood vessel, GI Tract or Trachea.
  • EGFR mutations, ALK translocations, ROS1 translocations which are sensitive to inhibitor therapy.
  • History of cerebrovascular accident and coagulation disorders.
  • Participants with interstitial lung disease, history of cerebrovascular accident or history of abdominal fistula, gastrointestinal perforation, bowel obstruction, intra-abdominal abscess or grade 3-4 bleeding event within 6 months prior to randomization.
  • Known toxicity on prior checkpoint inhibitor treatment.
  • Participants who received more than one line of anti- PD-1/PD-L1 treatment.
  • Participants who received previous CTLA-4 inhibitor treatment.
  • Participants with known BRAF V600E mutation which are sensitive to available targeted inhibitor therapy are excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Local Institution

Detroit, Michigan, 48201, United States

Location

Local Institution

Ciudad Autónoma de Buenos Aires, Buenos Aires, 1426, Argentina

Location

Local Institution

Buenos Aires, Distrito Federal, 1431, Argentina

Location

Local Institution

Buenos Aires, Distrito Federal, C1199ABB, Argentina

Location

Local Institution

Caba, Distrito Federal, 1430, Argentina

Location

Local Institution

Capital, Distrito Federal, C1280, Argentina

Location

Local Institution

Charleroi, 6000, Belgium

Location

Local Institution

Gilly, 6060, Belgium

Location

Local Institution

Leuven, 3000, Belgium

Location

Local Institution

Copenhagen Ø, 2100, Denmark

Location

Local Institution

Athens, 11527, Greece

Location

Local Institution

Neo Faliro, 18547, Greece

Location

Local Institution

Torreón, Coahuila, 27010, Mexico

Location

Local Institution

Zapopan, Jalisco, 44280, Mexico

Location

Local Institution

Mexico City, Mexico City, 03240, Mexico

Location

Local Institution

Puebla City, Puebla, 72530, Mexico

Location

Local Institution

Amsterdam, 1066 CX, Netherlands

Location

Local Institution

Rotterdam, 3015 GD, Netherlands

Location

Local Institution

Oslo, 0379, Norway

Location

Local Institution

Warsaw, Masovian Voivodeship, 02-781, Poland

Location

Local Institution

Krakow, 30-688, Poland

Location

Local Institution

Craiova, 200347, Romania

Location

Local Institution

Timișoara, 300696, Romania

Location

Related Links

MeSH Terms

Conditions

CarcinomaCarcinoma, Non-Small-Cell Lung

Interventions

NivolumabIpilimumabcabozantinibDocetaxelRamucirumabE-3810

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2019

First Posted

November 5, 2019

Study Start

April 15, 2021

Primary Completion

December 17, 2023

Study Completion

May 13, 2026

Last Updated

December 19, 2023

Record last verified: 2023-12

Locations

US(1)ME(4)NO(1)DK(1)PL(2)GR(2)NL(2)AR(5)RO(2)BE(3)