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 (CheckMate 79X)
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ClinicalTrials.gov Identifier: NCT04151563 |
Recruitment Status :
Withdrawn
(Business objectives have changed)
First Posted : November 5, 2019
Last Update Posted : February 17, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Carcinoma, Non-small Cell Lung Cancer | Biological: nivolumab Biological: ipilimumab Drug: cabozantinib Biological: docetaxel Biological: ramucirumab Drug: lucitanib | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1/2, Randomized Study Evaluating Multiple Nivolumab Combination Therapies in Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC) After Failure of Platinum-Based Chemotherapy and Anti-PD-1 (L)1 Immunotherapy |
Estimated Study Start Date : | April 15, 2021 |
Estimated Primary Completion Date : | December 17, 2023 |
Estimated Study Completion Date : | May 13, 2026 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm A: cabozantinib + nivolumab + ipilimumab |
Biological: nivolumab
Specified dose on Specified days
Other Names:
Biological: ipilimumab Specified dose on Specified days
Other Name: YERVOY Drug: cabozantinib Specified dose on Specified days
Other Name: CABOMETYX |
Experimental: Arm B: cabozantinib + nivolumab |
Biological: nivolumab
Specified dose on Specified days
Other Names:
Drug: cabozantinib Specified dose on Specified days
Other Name: CABOMETYX |
Experimental: Arm C: nivolumab + ramucirumab + docetaxel |
Biological: nivolumab
Specified dose on Specified days
Other Names:
Biological: docetaxel Specified dose on Specified days Biological: ramucirumab Specified dose on Specified days
Other Name: CYRAMZA |
Experimental: Arm D: lucitanib + nivolumab |
Biological: nivolumab
Specified dose on Specified days
Other Names:
Drug: lucitanib Specified dose on Specified days
Other Name: CO-3810 |
Experimental: Arm E: nivolumab + docetaxel |
Biological: nivolumab
Specified dose on Specified days
Other Names:
Biological: docetaxel Specified dose on Specified days |
Active Comparator: Arm F: docetaxel |
Biological: docetaxel
Specified dose on Specified days |
- Overall Reponse Rate (ORR) using RECIST 1.1 per Blinded Independent Central Review (BICR) assessment [ Time Frame: approximately 33 months ]
- Overall Survival (OS) [ Time Frame: Up to 5 Years ]
- Duration of Response (DOR) by BICR using RECIST 1.1 [ Time Frame: approximately 33 months ]
- Progression-Free Survival (PFS) by BICR using RECIST 1.1 [ Time Frame: Up to 5 Years ]
- Incidence of Adverse Events (AEs) [ Time Frame: Up to 5 Years ]
- Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 5 Years ]
- Incidence of Select AEs [ Time Frame: Up to 5 Years ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- 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.
Exclusion Criteria
- 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 interstital 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
Other protocol defined inclusion/exclusion criteria could apply

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04151563
United States, Michigan | |
Local Institution | |
Detroit, Michigan, United States, 48201 | |
Argentina | |
Local Institution | |
Caba, Buenos Aires, Argentina, 1430 | |
Local Institution | |
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina, 1426 | |
Local Institution | |
Buenos Aires, Distrito Federal, Argentina, 1431 | |
Local Institution | |
Buenos Aires, Distrito Federal, Argentina, C1199ABB | |
Local Institution | |
Capital, Distrito Federal, Argentina, C1280 | |
Belgium | |
Local Institution | |
Charleroi, Belgium, 6000 | |
Local Institution | |
Gilly, Belgium, 6060 | |
Local Institution | |
Leuven, Belgium, 3000 | |
Chile | |
Local Institution | |
Santiago, Metropolitana, Chile, 7500921 | |
Local Institution | |
Santiago, Metropolitana, Chile, 8420383 | |
Denmark | |
Local Institution | |
Copenhagen ?, Denmark, 2100 | |
France | |
Local Institution | |
Nantes, France, 44093 | |
Local Institution | |
Paris Cedex 5, France, 75248 | |
Local Institution | |
Rennes, France, 35033 | |
Greece | |
Local Institution | |
Athens, Greece, 11527 | |
Local Institution | |
Neo Faliro, Greece, 18547 | |
Mexico | |
Local Institution | |
Torreon, Coahuila, Mexico, 27010 | |
Local Institution | |
Ciudad de Mexico, Distrito Federal, Mexico, 03240 | |
Local Institution | |
Zapopan, Jalisco, Mexico, 44280 | |
Local Institution | |
Heroica Puebla de Zaragoza, Puebla, Mexico, 72530 | |
Netherlands | |
Local Institution | |
Amsterdam, Netherlands, 1066 CX | |
Local Institution | |
Rotterdam, Netherlands, 3015 GD | |
Norway | |
Local Institution | |
Oslo, Norway, 0379 | |
Poland | |
Local Institution | |
Warszawa, Mazowieckie, Poland, 02-781 | |
Local Institution | |
Krakow, Poland, 30-688 | |
Romania | |
Local Institution | |
Craiova, Romania, 200347 | |
Local Institution | |
Timisoara, Romania, 300696 | |
Spain | |
Local Institution | |
A Coru?a, Spain, 15006 | |
Local Institution | |
Barcelona, Spain, 08035 | |
Local Institution | |
Barcelona, Spain, 08036 | |
Local Institution | |
Madrid, Spain, 28041 | |
Local Institution | |
Majadahonda - Madrid, Spain, 28222 | |
Local Institution | |
Malaga, Spain, 29010 | |
Local Institution | |
Santiago Compostela, Spain, 15706 | |
Local Institution | |
Sevilla, Spain, 41014 | |
Local Institution | |
Valencia, Spain, 46026 |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT04151563 |
Other Study ID Numbers: |
CA209-79X 2018-004283-65 ( EudraCT Number ) |
First Posted: | November 5, 2019 Key Record Dates |
Last Update Posted: | February 17, 2021 |
Last Verified: | February 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |
Docetaxel Nivolumab Ipilimumab Ramucirumab Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Immunological |