Trial Outcomes & Findings for Single Agent Chemotherapy +/- Nivolumab in Patients With Advanced Squamous or Non-squamous NSCLC With Primary Resistance to Prior PD-1 or PDL-1 Inhibitor (NCT NCT03041181)

Last Updated: 2022-07-11

Results Overview

Compare PFS rates for subjects on each treatment arm, per RECIST 1.1. Subjects who have not progressed will be right-censored at the date of the last follow up.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

24 months

Results posted on

2022-07-11

Participant Flow

Participant milestones

Participant milestones
Measure	Arm A - Single Agent Chemotherapy + Nivolumab Single Agent Chemotherapy of choice plus nivolumab: Taxotere Pemetrexed Gemcitabine Docetaxel: Docetaxel 75 mg/m2 IV Day 1 of each cycle (21 days = 1 cycle) Nivolumab: Nivolumab 360 mg IV Day 1 of each cycle (21 days = 1 cycle) Gemcitabine: Gemcitabine 1000 mg/m2 IV Day 1 and Day 8 of each cycle (21 days = 1 cycle) Pemetrexed: Pemetrexed 500 mg/m2 IV Day 1 of each cycle (21 days = 1 cycle)	Arm B - Single Agent Chemotherapy Single Agent Chemotherapy of choice Taxotere Pemetrexed Gemcitabine Docetaxel: Docetaxel 75 mg/m2 IV Day 1 of each cycle (21 days = 1 cycle) Gemcitabine: Gemcitabine 1000 mg/m2 IV Day 1 and Day 8 of each cycle (21 days = 1 cycle) Pemetrexed: Pemetrexed 500 mg/m2 IV Day 1 of each cycle (21 days = 1 cycle)
Overall Study STARTED	1	2
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A - Single Agent Chemotherapy + Nivolumab Single Agent Chemotherapy of choice plus nivolumab: Taxotere Pemetrexed Gemcitabine Docetaxel: Docetaxel 75 mg/m2 IV Day 1 of each cycle (21 days = 1 cycle) Nivolumab: Nivolumab 360 mg IV Day 1 of each cycle (21 days = 1 cycle) Gemcitabine: Gemcitabine 1000 mg/m2 IV Day 1 and Day 8 of each cycle (21 days = 1 cycle) Pemetrexed: Pemetrexed 500 mg/m2 IV Day 1 of each cycle (21 days = 1 cycle)	Arm B - Single Agent Chemotherapy Single Agent Chemotherapy of choice Taxotere Pemetrexed Gemcitabine Docetaxel: Docetaxel 75 mg/m2 IV Day 1 of each cycle (21 days = 1 cycle) Gemcitabine: Gemcitabine 1000 mg/m2 IV Day 1 and Day 8 of each cycle (21 days = 1 cycle) Pemetrexed: Pemetrexed 500 mg/m2 IV Day 1 of each cycle (21 days = 1 cycle)
Overall Study Disease Progression	1	2

Baseline Characteristics

Single Agent Chemotherapy +/- Nivolumab in Patients With Advanced Squamous or Non-squamous NSCLC With Primary Resistance to Prior PD-1 or PDL-1 Inhibitor

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 24 months

Population: Data for this objective was neither collected or analyzed due to the early termination of the study.

Compare PFS rates for subjects on each treatment arm, per RECIST 1.1. Subjects who have not progressed will be right-censored at the date of the last follow up.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Every 6 weeks beginning with C3D1 and every odd numbered cycle thereafter, assessed for up to 24 months

Population: Data for this objective was neither collected or analyzed due to the early termination of the study.

Proportion of subjects on each arm with complete response or partial response, per RECIST 1.1 and irRECIST

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From D1 of treatment until documented disease progression/recurrence, assessed for up to 24 months

Population: Data for this objective was neither collected or analyzed due to the early termination of the study.

Proportion of subjects on each arm with complete response, partial response or stable disease for at least 3 months, per RECIST 1.1 and irRECIST

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

Population: Data for this objective was neither collected or analyzed due to the early termination of the study.

Compare PFS rates for subjects on each treatment arm, per irRECIST. From date of randomization until the criteria for disease progression is met or death as a result of any cause, assessed up to 24 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Assess toxicity of Nivolumab plus single agent chemotherapy compared with single agent chemotherapy alone. Number of grade 3 and 4 toxicities as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.

Outcome measures

Outcome measures
Measure	Arm A n=1 Participants Single Agent Chemotherapy of choice plus nivolumab: Taxotere Pemetrexed Gemcitabine Docetaxel: Docetaxel 75 mg/m2 IV Day 1 of each cycle (21 days = 1 cycle) Nivolumab: Nivolumab 360 mg IV Day 1 of each cycle (21 days = 1 cycle) Gemcitabine: Gemcitabine 1000 mg/m2 IV Day 1 and Day 8 of each cycle (21 days = 1 cycle) Pemetrexed: Pemetrexed 500 mg/m2 IV Day 1 of each cycle (21 days = 1 cycle)	Arm B n=2 Participants Single Agent Chemotherapy of choice Taxotere Pemetrexed Gemcitabine Docetaxel: Docetaxel 75 mg/m2 IV Day 1 of each cycle (21 days = 1 cycle) Gemcitabine: Gemcitabine 1000 mg/m2 IV Day 1 and Day 8 of each cycle (21 days = 1 cycle) Pemetrexed: Pemetrexed 500 mg/m2 IV Day 1 of each cycle (21 days = 1 cycle)
Number of Participants With Grade 3 or Grade 4 Adverse Events GR4 Thromboembolic Event	0 participants	1 participants
Number of Participants With Grade 3 or Grade 4 Adverse Events GR3 Adverse Events	0 participants	0 participants

Adverse Events

Arm A

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Arm B

Serious events: 1 serious events

Other events: 2 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Arm A n=1 participants at risk Single Agent Chemotherapy of choice plus nivolumab: Taxotere Pemetrexed Gemcitabine Docetaxel: Docetaxel 75 mg/m2 IV Day 1 of each cycle (21 days = 1 cycle) Nivolumab: Nivolumab 360 mg IV Day 1 of each cycle (21 days = 1 cycle) Gemcitabine: Gemcitabine 1000 mg/m2 IV Day 1 and Day 8 of each cycle (21 days = 1 cycle) Pemetrexed: Pemetrexed 500 mg/m2 IV Day 1 of each cycle (21 days = 1 cycle)	Arm B n=2 participants at risk Single Agent Chemotherapy of choice Taxotere Pemetrexed Gemcitabine Docetaxel: Docetaxel 75 mg/m2 IV Day 1 of each cycle (21 days = 1 cycle) Gemcitabine: Gemcitabine 1000 mg/m2 IV Day 1 and Day 8 of each cycle (21 days = 1 cycle) Pemetrexed: Pemetrexed 500 mg/m2 IV Day 1 of each cycle (21 days = 1 cycle)
Vascular disorders THROMBOEMBOLIC EVENT	0.00% 0/1 • Adverse events are to be collected for the duration of the subject's participation on study, up to a maximum of six months.	50.0% 1/2 • Number of events 1 • Adverse events are to be collected for the duration of the subject's participation on study, up to a maximum of six months.

Other adverse events

Additional Information

Clinicaltrials.gov Results Coordinator

Hoosier Cancer Research Network

Phone: 317-643-5842

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Arm A n=1 Participants Single Agent Chemotherapy of choice plus nivolumab: Taxotere Pemetrexed Gemcitabine Docetaxel: Docetaxel 75 mg/m2 IV Day 1 of each cycle (21 days = 1 cycle) Nivolumab: Nivolumab 360 mg IV Day 1 of each cycle (21 days = 1 cycle) Gemcitabine: Gemcitabine 1000 mg/m2 IV Day 1 and Day 8 of each cycle (21 days = 1 cycle) Pemetrexed: Pemetrexed 500 mg/m2 IV Day 1 of each cycle (21 days = 1 cycle)	Arm B n=2 Participants Single Agent Chemotherapy of choice Taxotere Pemetrexed Gemcitabine Docetaxel: Docetaxel 75 mg/m2 IV Day 1 of each cycle (21 days = 1 cycle) Gemcitabine: Gemcitabine 1000 mg/m2 IV Day 1 and Day 8 of each cycle (21 days = 1 cycle) Pemetrexed: Pemetrexed 500 mg/m2 IV Day 1 of each cycle (21 days = 1 cycle)	Total n=3 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants
Histology Adenocarcinoma	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Histology Large Cell Carcinoma	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Histology Mixed Histology	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Histology Non-small Cell Carcinoma	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Histology Sqamous	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

Measure	Arm A n=1 participants at risk Single Agent Chemotherapy of choice plus nivolumab: Taxotere Pemetrexed Gemcitabine Docetaxel: Docetaxel 75 mg/m2 IV Day 1 of each cycle (21 days = 1 cycle) Nivolumab: Nivolumab 360 mg IV Day 1 of each cycle (21 days = 1 cycle) Gemcitabine: Gemcitabine 1000 mg/m2 IV Day 1 and Day 8 of each cycle (21 days = 1 cycle) Pemetrexed: Pemetrexed 500 mg/m2 IV Day 1 of each cycle (21 days = 1 cycle)	Arm B n=2 participants at risk Single Agent Chemotherapy of choice Taxotere Pemetrexed Gemcitabine Docetaxel: Docetaxel 75 mg/m2 IV Day 1 of each cycle (21 days = 1 cycle) Gemcitabine: Gemcitabine 1000 mg/m2 IV Day 1 and Day 8 of each cycle (21 days = 1 cycle) Pemetrexed: Pemetrexed 500 mg/m2 IV Day 1 of each cycle (21 days = 1 cycle)
Respiratory, thoracic and mediastinal disorders ALLERGIC RHINITIS	100.0% 1/1 • Number of events 1 • Adverse events are to be collected for the duration of the subject's participation on study, up to a maximum of six months.	0.00% 0/2 • Adverse events are to be collected for the duration of the subject's participation on study, up to a maximum of six months.
Gastrointestinal disorders CONSTIPATION	100.0% 1/1 • Number of events 1 • Adverse events are to be collected for the duration of the subject's participation on study, up to a maximum of six months.	0.00% 0/2 • Adverse events are to be collected for the duration of the subject's participation on study, up to a maximum of six months.
Nervous system disorders HEADACHE	100.0% 1/1 • Number of events 2 • Adverse events are to be collected for the duration of the subject's participation on study, up to a maximum of six months.	0.00% 0/2 • Adverse events are to be collected for the duration of the subject's participation on study, up to a maximum of six months.
Vascular disorders HOT FLASHES	100.0% 1/1 • Number of events 1 • Adverse events are to be collected for the duration of the subject's participation on study, up to a maximum of six months.	0.00% 0/2 • Adverse events are to be collected for the duration of the subject's participation on study, up to a maximum of six months.
Investigations INVESTIGATIONS - OTHER, SPECIFY	100.0% 1/1 • Number of events 2 • Adverse events are to be collected for the duration of the subject's participation on study, up to a maximum of six months.	0.00% 0/2 • Adverse events are to be collected for the duration of the subject's participation on study, up to a maximum of six months.
Infections and infestations LUNG INFECTION	100.0% 1/1 • Number of events 1 • Adverse events are to be collected for the duration of the subject's participation on study, up to a maximum of six months.	0.00% 0/2 • Adverse events are to be collected for the duration of the subject's participation on study, up to a maximum of six months.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER - OTHER, SPECIFY	100.0% 1/1 • Number of events 2 • Adverse events are to be collected for the duration of the subject's participation on study, up to a maximum of six months.	50.0% 1/2 • Number of events 1 • Adverse events are to be collected for the duration of the subject's participation on study, up to a maximum of six months.
Respiratory, thoracic and mediastinal disorders PRODUCTIVE COUGH	100.0% 1/1 • Number of events 2 • Adverse events are to be collected for the duration of the subject's participation on study, up to a maximum of six months.	0.00% 0/2 • Adverse events are to be collected for the duration of the subject's participation on study, up to a maximum of six months.
Infections and infestations SINUSITIS	100.0% 1/1 • Number of events 1 • Adverse events are to be collected for the duration of the subject's participation on study, up to a maximum of six months.	0.00% 0/2 • Adverse events are to be collected for the duration of the subject's participation on study, up to a maximum of six months.
Blood and lymphatic system disorders ANEMIA	0.00% 0/1 • Adverse events are to be collected for the duration of the subject's participation on study, up to a maximum of six months.	50.0% 1/2 • Number of events 1 • Adverse events are to be collected for the duration of the subject's participation on study, up to a maximum of six months.
Psychiatric disorders ANXIETY	0.00% 0/1 • Adverse events are to be collected for the duration of the subject's participation on study, up to a maximum of six months.	50.0% 1/2 • Number of events 1 • Adverse events are to be collected for the duration of the subject's participation on study, up to a maximum of six months.
Respiratory, thoracic and mediastinal disorders COUGH	0.00% 0/1 • Adverse events are to be collected for the duration of the subject's participation on study, up to a maximum of six months.	50.0% 1/2 • Number of events 1 • Adverse events are to be collected for the duration of the subject's participation on study, up to a maximum of six months.
Psychiatric disorders DEPRESSION	0.00% 0/1 • Adverse events are to be collected for the duration of the subject's participation on study, up to a maximum of six months.	50.0% 1/2 • Number of events 1 • Adverse events are to be collected for the duration of the subject's participation on study, up to a maximum of six months.
Respiratory, thoracic and mediastinal disorders DYSPNEA	0.00% 0/1 • Adverse events are to be collected for the duration of the subject's participation on study, up to a maximum of six months.	50.0% 1/2 • Number of events 1 • Adverse events are to be collected for the duration of the subject's participation on study, up to a maximum of six months.
Psychiatric disorders INSOMNIA	0.00% 0/1 • Adverse events are to be collected for the duration of the subject's participation on study, up to a maximum of six months.	50.0% 1/2 • Number of events 1 • Adverse events are to be collected for the duration of the subject's participation on study, up to a maximum of six months.
Respiratory, thoracic and mediastinal disorders NASAL CONGESTION	0.00% 0/1 • Adverse events are to be collected for the duration of the subject's participation on study, up to a maximum of six months.	50.0% 1/2 • Number of events 1 • Adverse events are to be collected for the duration of the subject's participation on study, up to a maximum of six months.
General disorders NON-CARDIAC CHEST PAIN	0.00% 0/1 • Adverse events are to be collected for the duration of the subject's participation on study, up to a maximum of six months.	50.0% 1/2 • Number of events 2 • Adverse events are to be collected for the duration of the subject's participation on study, up to a maximum of six months.
Nervous system disorders PERIPHERAL SENSORY NEUROPATHY	0.00% 0/1 • Adverse events are to be collected for the duration of the subject's participation on study, up to a maximum of six months.	50.0% 1/2 • Number of events 1 • Adverse events are to be collected for the duration of the subject's participation on study, up to a maximum of six months.
Respiratory, thoracic and mediastinal disorders PNEUMOTHORAX	0.00% 0/1 • Adverse events are to be collected for the duration of the subject's participation on study, up to a maximum of six months.	50.0% 1/2 • Number of events 1 • Adverse events are to be collected for the duration of the subject's participation on study, up to a maximum of six months.